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  4. [8-K] Avalyn Pharma Inc. Reports Material Event

Avalyn Pharma (Nasdaq: AVLN) ends Q2 2026 with $413M cash and advances fibrosis trials

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

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.

Positive

  • $413.5 million in cash, cash equivalents and marketable securities as of June 30, 2026, with management projecting a cash runway into 2029.
  • Global Phase 2b MIST trial of AP01 fully enrolled with 398 patients, exceeding the 375-patient target and positioning for topline data in the second half of 2027.
  • Pipeline advancing on multiple fronts: AP02 AURA Phase 2 enrollment ongoing in IPF and AP03 Phase 1 study planned to initiate by the end of 2026.

Negative

  • Quarterly net loss increased to $28.9 million in Q2 2026 from $20.2 million in Q2 2025, reflecting higher operating expenses.
  • Research and development expenses rose to $24.7 million in Q2 2026 from $17.9 million a year earlier as clinical programs expanded, increasing cash burn.

Filing Explained

This Form 8-K furnishes Avalyn’s quarterly results for the period ended June 30, 2026 under Item 2.02; the results and attached release are not treated as filed under Exchange Act Section 18 or incorporated by reference unless separately specified.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash, cash equivalents and marketable securities $413,528 thousand As of June 30, 2026; projected to fund operations into 2029
Net proceeds from IPO $316.6 million Net proceeds from initial public offering completed in May 2026
Research and development expenses $24,729 thousand Three months ended June 30, 2026 (vs. $17,882 thousand in 2025)
General and administrative expenses $6,561 thousand Three months ended June 30, 2026 (vs. $3,895 thousand in 2025)
Net loss $28,935 thousand Three months ended June 30, 2026 (vs. $20,191 thousand in 2025)
Total assets $425,448 thousand As of June 30, 2026 (vs. $148,881 thousand at December 31, 2025)
Total liabilities $27,102 thousand As of June 30, 2026 (vs. $15,316 thousand at December 31, 2025)
MIST trial enrollment 398 patients Global Phase 2b AP01 trial, over-enrolled vs 375-patient target
progressive pulmonary fibrosis medical
"trial evaluating two doses of AP01 ... in patients with progressive pulmonary fibrosis (PPF)"
Progressive pulmonary fibrosis is a condition where lung tissue becomes increasingly scarred and stiff over time, reducing the lungs’ ability to move air and exchange oxygen—imagine a once-spongey lung turning into a hardened sponge that can’t expand. It matters to investors because a growing or underserved patient population, ongoing clinical trials, and potential new treatments or diagnostics can drive revenue, regulatory milestones, partnership activity, and share-price volatility in healthcare, biotech, and medical-device companies.
idiopathic pulmonary fibrosis medical
"AURA is a randomized, double-blind global trial ... in patients with IPF"
Idiopathic pulmonary fibrosis is a chronic lung disease in which the air‑carrying tissue becomes progressively thickened and scarred for no identifiable reason, making the lungs stiff and less able to move oxygen—similar to a sponge that hardens and loses its pores. It matters to investors because it is life‑limiting with limited effective treatments, so clinical trial outcomes, regulatory approvals, pricing and reimbursement decisions can strongly affect the commercial value of therapies and the financial prospects of companies developing treatments.
forced vital capacity (FVC) medical
"primary endpoint of change in lung function measured by forced vital capacity (FVC)"
Forced vital capacity (FVC) is the total amount of air a person can forcefully exhale after taking the deepest breath possible, measured during a simple breathing test. Investors care because changes in FVC are a common, straightforward measure used in clinical trials and regulatory evaluations for respiratory drugs and devices, acting like a yardstick that shows whether a treatment is improving lung capacity or slowing disease progression.
open label extension study medical
"driven by the ongoing AP01 and AP02 clinical trials and the AP01 open label extension study, SAIL"
initial public offering financial
"includes net proceeds of approximately $316.6 million from its initial public offering in May 2026"
An initial public offering (IPO) is when a private company first sells its shares to the public and becomes a stock-listed company. It matters because it allows the company to raise money from a wide range of investors, helping it grow, while giving early shareholders a way to sell some of their ownership.
Net loss (Q2 2026) $28,935 thousand Compared with $20,191 thousand in Q2 2025
Research and development expenses (Q2 2026) $24,729 thousand Compared with $17,882 thousand in Q2 2025
General and administrative expenses (Q2 2026) $6,561 thousand Compared with $3,895 thousand in Q2 2025
Cash, cash equivalents and marketable securities $413,528 thousand Increased from $138,359 thousand at December 31, 2025

FAQ

What were Avalyn Pharma (AVLN)’s cash and investments at June 30, 2026?
Avalyn reported $413.5 million in cash, cash equivalents and marketable securities as of June 30, 2026. This total includes approximately $316.6 million in net proceeds from its May 2026 initial public offering and is expected to fund operations into 2029.

How much did Avalyn Pharma (AVLN) lose in the second quarter of 2026?
Avalyn recorded a net loss of $28.9 million for the quarter ended June 30, 2026, compared with a net loss of $20.2 million in the same period of 2025, driven primarily by higher research and development and general and administrative expenses.

What are the key clinical milestones for Avalyn Pharma (AVLN)’s AP01 program?
Avalyn has completed global enrollment in the MIST Phase 2b trial of AP01 in progressive pulmonary fibrosis with 398 patients. The 52-week study’s topline data are anticipated in the second half of 2027, with forced vital capacity as the primary endpoint.

How is Avalyn Pharma (AVLN) progressing its AP02 and AP03 respiratory programs?
The AURA Phase 2 trial of AP02 in idiopathic pulmonary fibrosis is enrolling up to 160 patients, with topline data expected in late 2027. A Phase 1 trial of combination candidate AP03, inhaled nintedanib plus pirfenidone, is planned to initiate by the end of 2026.

What were Avalyn Pharma (AVLN)’s operating expenses in Q2 2026?
Total operating expenses were $31.3 million in Q2 2026, including $24.7 million of research and development and $6.6 million of general and administrative costs. This compares with $21.8 million of total operating expenses in the second quarter of 2025.

How did Avalyn Pharma (AVLN)’s balance sheet change between December 2025 and June 2026?
Total assets increased from $148.9 million at December 31, 2025 to $425.4 million at June 30, 2026, while total liabilities rose from $15.3 million to $27.1 million, reflecting IPO proceeds and growth in operations.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Understanding 8-K Material Events →
false000154017100015401712026-08-122026-08-12

 

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): August 12, 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 August 12, 2026, Avalyn Pharma Inc. (the “Company”) announced its financial results for the quarter ended June 30, 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 August 12, 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:

August 12, 2026

By:

/s/ Lyn Baranowski

 

 

 

Lyn Baranowski
Chief Executive Officer
(Principal Executive Officer)

 

 

Avalyn Reports Second Quarter 2026 Financial Results and Recent Business Highlights

 

Completed enrollment of MIST global Phase 2b trial of AP01 with 398 patients; topline data expected in the second half of 2027

 

Two abstracts accepted for presentation at the European Respiratory Society (ERS) Congress, including data modeling AP01 lung tissue distribution

 

Ended the second quarter of 2026 with $413.5 million in cash, cash equivalents and marketable securities; cash runway projected into 2029

 

 

BOSTON, MA, August 12, 2026 -- Avalyn Pharma Inc. (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 second quarter ended June 30, 2026 and recent business highlights.

 

“Completing global enrollment in MIST marks a significant milestone for Avalyn, and the degree of over-enrollment in this study is a testament to the high level of interest from investigators and patients,” said Lyn Baranowski, Chief Executive Officer of Avalyn Pharma. “This achievement also reflects the dedication and strong execution demonstrated by our teams, who have worked tirelessly to advance the program. Pulmonary fibrosis is a devastating disease with few effective medications, and too many patients remain untreated due to the tolerability challenges associated with currently available options. With AP01, AP02, and our emerging combination therapy product candidate AP03, we are building a differentiated platform designed to unlock the full value of established antifibrotic medications, support longer-term treatment, and improve patient outcomes. We are proud of the progress we have made and believe our approach has the potential to drive sustained pipeline expansion and position Avalyn as a leader in transforming the treatment of rare respiratory diseases.”

 

 

Recent Pipeline Progress

 

AP01 (inhaled pirfenidone)

 

•
MIST Phase 2b Trial Enrollment Complete. MIST is a randomized, double-blind, placebo-controlled global trial evaluating two doses of AP01 dosed twice daily in patients with progressive pulmonary fibrosis (PPF). This 52-week trial is designed to assess safety and efficacy of AP01, with a primary endpoint of change in lung function measured by forced vital capacity (FVC). The study overenrolled beyond its target enrollment of 375, with a total of 398 patients randomized into three treatment cohorts. Topline data are anticipated in the second half of 2027.

 

 

•
In September 2026, the Company plans to present two abstracts at the ERS Congress in Barcelona, Spain. The first poster will highlight data modeling effective AP01 distribution throughout the target tissue in both healthy and idiopathic pulmonary fibrosis (IPF) lungs. The second poster will describe the integration of patient perspectives into clinical trial design. Detailed poster session information will be provided in advance of the congress.

 

AP02 (inhaled nintedanib)

 

•
Enrollment On Track in AURA Phase 2 Trial. AURA is a randomized, double-blind global trial evaluating two doses of AP02 dosed twice daily in patients with IPF. Enrollment was initiated in the first quarter of 2026. The 12-week study is designed to enroll 160 patients and will assess safety and efficacy as measured by FVC. Topline data are anticipated in late 2027.

 

AP03 (inhaled combination of nintedanib and pirfenidone)

 

•
Advancing Next-Generation Therapy. A Phase 1 study of AP03, a fixed dose combination of inhaled pirfenidone and nintedanib, remains on track to initiate by the end of 2026.

 

 

Financial Results for Second Quarter 2026

 

Cash Position: Cash, cash equivalents, and marketable securities were $413.5 million

as of June 30, 2026. The Company’s current cash, cash equivalents, and marketable securities, which includes net proceeds of approximately $316.6 million from its initial public offering in May 2026, are projected to be sufficient to fund operations into 2029.

 

Research & Development (R&D) Expenses: R&D expenses were $24.7 million for the second quarter of 2026, as compared to $17.9 million for the second quarter of 2025. The increase in R&D expenses was primarily driven by the ongoing AP01 and AP02 clinical trials and the AP01 open label extension study, SAIL.

 

General & Administrative (G&A) Expenses: G&A expenses were $6.6 million for the second quarter of 2026, as compared to $3.9 million for the second quarter of 2025. The increase in G&A expenses was primarily driven by the increase of G&A headcount and personnel-related expenses, including stock-based compensation.

 

Net loss: Net loss was $28.9 million for the second quarter of 2026, as compared to $20.2 million for the second quarter of 2025.

About Avalyn Pharma
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has indicated encouraging safety and clinical

 

 

activity across Phase 1b and multi-year open-label extension trials, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.

Forward Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, implied and express statements about Avalyn’s beliefs and expectations regarding: topline data readout for MIST expected in the second half of 2027; the ongoing enrollment in the AURA Phase 2 trial of AP02 in patients with IPF and the expected timing of results in late 2027; the expected initiation of a Phase 1 trial of AP03 by the end of 2026, the interpretation and potential implications of clinical data; the potential of its product candidates to address significant unmet needs in the treatment of pulmonary fibrosis and related diseases; the possibility that improved tolerability may translate into clinically meaningful benefit; the advancement of its pulmonary fibrosis programs; the potential for any of the Company’s product candidates to establish or contribute to a new standard of care; and Avalyn’s expectations regarding the anticipated timeline of its cash runway and future financial performance.

 

 

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the risk that earlier results may not be indicative of future results, risks related to clinical trial site activation, delays in enrollment generally or enrollment rates that are lower than expected; delays related to assessment of clinical trial results; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions, risks related to our ability to protect and maintain our intellectual property position or relationships with third-parties, the initiation, timing, progress and results of our current and future research and development programs, preclinical studies and clinical trials; our ability to successfully complete our clinical trials; our ability to advance any product candidates that we may identify and successfully complete any clinical studies, including the manufacture of any such product candidates; the likelihood of our clinical trials demonstrating safety and efficacy of our product candidates; and risks related to needs for additional financing. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Avalyn’s current and future filings with the Securities and Exchange Commission, including those described from time to time under the caption “Risk Factors.” In addition, any forward-looking statements represent Avalyn’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Avalyn

 

 

explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

 

 

Investor Contact:
Cassie Saitow, Avalyn Pharma Inc.

Sr. Director, IR and Corporate Communications

ir@avalynpharma.com

 

Media Contact:

Precision AQ

avalyn@precisionaq.com

 

 

 

 

 

AVALYN PHARMA INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 

(In thousands, except share and per share amounts)

 

(Unaudited)

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

24,729

 

 

$

17,882

 

 

$

47,618

 

 

$

33,201

 

General and administrative

 

6,561

 

 

 

3,895

 

 

 

11,581

 

 

 

7,292

 

Total operating expenses

 

31,290

 

 

 

21,777

 

 

 

59,199

 

 

 

40,493

 

LOSS FROM OPERATIONS

 

(31,290

)

 

 

(21,777

)

 

 

(59,199

)

 

 

(40,493

)

OTHER INCOME (EXPENSE):

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

2,696

 

 

 

1,627

 

 

 

3,821

 

 

 

2,875

 

Interest expense

 

(272

)

 

 

—

 

 

 

(370

)

 

 

—

 

Other expense

 

(69

)

 

 

(41

)

 

 

(56

)

 

 

(76

)

Total other income

 

2,355

 

 

 

1,586

 

 

 

3,395

 

 

 

2,799

 

NET LOSS

$

(28,935

)

 

$

(20,191

)

 

$

(55,804

)

 

$

(37,694

)

 

 

AVALYN PHARMA INC.

 

CONSOLIDATED BALANCE SHEET DATA

 

(In thousands)

 

(Unaudited)

 

 

June 30,

 

 

December 31,

 

 

2026

 

 

2025

 

Cash, cash equivalents, and marketable securities

$

413,528

 

 

$

138,359

 

Total assets

 

425,448

 

 

 

148,881

 

Total liabilities

 

27,102

 

 

 

15,316

 

Total stockholders’ equity (deficit) and redeemable convertible preferred stock

$

398,346

 

 

$

133,565

 

 

 

Source: View Original Filing on SEC EDGAR

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