Avalyn Pharma Inc. (AVLN)

Price$37.39Cached quoteAs of 2026-09-05 07:47 UTC

AI: Overvalued

Price checkInvestors pay heavily for unproven drugs, leaving little balance-sheet protection.

Using 44.33 million June shares, the verified quote implies a basic market value near $1.49 billion. June cash and short-term investments were $413.5 million, against $17.1 million of reported debt, leaving about $396.4 million after debt. Investors therefore assign roughly $1.09 billion to the drug pipeline before accounting for options. That is nearly three times the remaining cash and offers little safety for a company with no revenue and no decisive mid-stage results until 2027.

Big pictureNo sales or profits exist yet, so trial outcomes drive nearly all value.

Avalyn has never generated revenue, and its first-half 2026 net loss widened to $55.8 million from $37.7 million. Cash used to run the business rose to $56.0 million from $40.0 million; minimal equipment spending means that figure closely reflects ongoing cash consumption. This business does not follow a normal economic cycle because it has no commercial sales. Its value instead rises or falls with patient enrollment, lung-function results, regulatory progress, and the spending required to reach those milestones.

Business strengthThe cash cushion reaches planned results, but shareholders paid through heavy dilution.

The main strength is $413.5 million of cash and readily saleable investments, which management expects to fund its current plan into 2029 and through planned 2027 results. Directing money to trials instead of dividends or buybacks is sensible for a pre-revenue developer. However, the May stock sale issued 19.17 million shares, while the total reached 44.33 million by June. Another 7.08 million options and warrants—rights to buy shares—could add roughly 16% to the basic count, although exercises would provide some cash.

What could change the storySuccess must confirm both lung benefit and tolerability before the premium looks justified.

The bull case requires the 398-patient AP01 study to preserve lung capacity with better tolerability than oral pirfenidone, while AP02 validates a second inhaled treatment. Success could support a valuable respiratory-drug platform. The bear case is that encouraging evidence mainly comes from early studies and open-label extensions, where patients and doctors know the treatment and historical comparisons are less reliable than randomized controls. Results are not expected until late 2027. Weak benefit, airway irritation, delays, or faster cash use would threaten the implied $1.09 billion pipeline value.

AI: News

Cash Lasts Into 2029Strong financing should fund key trial results, despite rapidly rising research costs.

On August 12, Avalyn reported $413.5 million of cash and readily saleable investments and said these resources should fund operations into 2029. Second-quarter research spending rose 38% to $24.7 million, while the net loss widened 43% to $28.9 million as AP01 and AP02 trials advanced. Shares gained 5.4% that session. The report likely reassured investors that 2027 results can arrive before another financing, although price timing alone cannot separate the announcement from other trading influences.

Key Study Enrollment CompletedAvalyn filled its main inhaled-drug study early, reducing delay risk before 2027 results.

On June 17, Avalyn said its main AP01 study had reached the 375-patient target ahead of schedule; by August, 398 patients had been assigned across two doses and a placebo group. The 52-week trial measures changes in lung capacity and should report during the second half of 2027. Shares gained 4.4% that day and 7.3% the next session. The timing is consistent with investor approval, but it does not prove that this announcement caused the moves.

Large Stock Sale CompletedA large public stock sale funded the pipeline while sharply expanding ownership.

Avalyn priced an upsized public offering on April 29 and completed it May 1. The company sold 19.17 million shares and raised $345.0 million before costs, or approximately $316.6 million after costs. Trading began April 30, and the first close stood about 64% above the offering level, signaling strong initial demand without proving lasting value. The proceeds materially reduce near-term financing risk, but the larger share count spreads any future value from successful drugs across more owners.

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Revenue

2024

2025

Net income

2024

2025

Free cash flow

2024

2025

Total cash / debt

CashTotal debt

2024

2025

Financial statements

	2025	2024
Revenue	$0	$0
Research & development	$76.6M	$45.8M
Operating expenses	$91.3M	$57.1M
Operating income	−$91.3M	−$57.1M
EBITDA	−$91.3M	−$57.1M
Net income	−$85.2M	−$49.7M
Basic EPSper basic share	-$2.04	-$1.19
Diluted EPSper diluted share	-$2.04	-$1.19

Review official source filings ↗

Owners

Reported shareholders

Reference date Jun 30, 2026

13.16%of listed shares

FMR LLC5.84M shares · Jun 30, 2026

View holders

Top 20 reported holders of AVLN
Holder	% owned
FMR LLC	13.16%5.84M shares
NOVO HOLDINGS A/S	8.76%3.88M shares
George Simeon / SR ONE CAPITAL MANAGEMENT, LLC	≈7.46%3.31M shares
SR One Capital Management, LP	7.46%3.31M shares
PERCEPTIVE ADVISORS LLC	6.03%2.68M shares
MONTANOVA CAPITAL, LLC	5.65%2.5M shares
NVP ASSOCIATES, LLC	5.12%2.27M shares
WELLINGTON MANAGEMENT GROUP LLP	4.97%2.2M shares
Carroll Jill	≈4.93%2.19M shares
PRICE T ROWE ASSOCIATES INC /MD/	3.91%1.74M shares
Catalio Capital Management, LP	3.78%1.68M shares
T. Rowe Price Investment Management, Inc.	3.62%1.6M shares
EVENTIDE ASSET MANAGEMENT, LLC	3.10%1.38M shares
Bellevue Group AG	3.05%1.35M shares
Wellington Biomedical Innovation Master Investors (Cayman) II L.P.	≈2.88%1.28M shares
BlackRock, Inc.	2.20%977.26K shares
Pivotal bioVenture Partners Investment Advisor LLC	2.18%966.79K shares
CITADEL ADVISORS LLC	2.16%959.1K shares
ANDERA PARTNERS	2.10%929.82K shares
JENNISON ASSOCIATES LLC	1.83%812.75K shares

Percentages use 44.33M shares of this listed class outstanding on Jun 30, 2026. ≈ compares the latest reported holding with a share total from a different date; it is not a confirmed current stake.

Gray completes the 100% scale. Reported positions may overlap; holders have different reporting dates.

Source: SEC Form 13F ↗Updated Sep 29, 2026 · Quarterly data

Insider buys & sells

Jul 1, 2024–Jun 30, 2026

Buys4$25.00M disclosed value

Sells (SEC code S)0$0.00 disclosed value

Transaction	Insider	Type	Shares	Price	Value	Owned after
May 1, 2026Form 4	Novo Holdings A/STenPercentOwner	BuyVoting Common Stock	555.6K	$18.00	$10.00M	3.88M
May 1, 2026Form 4	Carroll JillDirector	BuyCommon Stock · indirect	277.8K	$18.00	$5.00M	2.19M
May 1, 2026Form 4	George Simeon +1TenPercentOwner	BuyCommon Stock · indirect	277.8K	$18.00	$5.00M	1.12M
May 1, 2026Form 4	George Simeon +1TenPercentOwner	BuyCommon Stock · indirect	277.8K	$18.00	$5.00M	2.19M

Review ownership filings at SEC.gov ↗

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Avalyn Pharma Inc. (AVLN)

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