Pulmatrix Announces Third Quarter 2025 Financial Results and Divestment Plan for Migraine and Inhalation Assets

Rhea-AI Summary

Pulmatrix (Nasdaq: PULM) reported third quarter 2025 results and a corporate update on Oct 16, 2025, announcing intent to divest its iSPERSE dry powder inhalation technology and three related clinical programs as part of a proposed merger with Cullgen.

Key metrics: cash $4.8M (Sept 30, 2025) with anticipated runway into Q4 2026; Q3 revenue $0 (down ~$0.4M YoY); Q3 net loss $0.877M; accumulated deficit $301.4M. Material assets include PUR3100 (Phase 2‑ready with FDA IND acceptance and a “study may proceed” letter), PUR1800 (Phase 1b topline supportive data), PUR1900 (partnered with Cipla; 2% royalty outside U.S.), and a patent portfolio of approximately 146 granted patents plus ~50 pending applications.

The merger with Cullgen was stockholder‑approved on June 16, 2025 but remains subject to customary closing conditions including Nasdaq listing approval and approval from the China Security Regulatory Commission. Management is pursuing divestment of the iSPERSE portfolio and clinical assets concurrent with the merger process.

Positive

• PUR3100 Phase 2‑ready with FDA IND acceptance and a “study may proceed” letter
• iSPERSE patent portfolio ~146 granted patents and ~50 pending applications
• Cash balance of $4.8M as of Sept 30, 2025, runway into Q4 2026
• Stockholder approval of the proposed merger on June 16, 2025

Negative

• Q3 2025 revenue $0, down ~$0.4M versus Q3 2024
• Q3 2025 net loss $0.877M and accumulated deficit $301.4M
• Merger closing remains conditional on Nasdaq listing approval and China regulator consent

Insights

Corporate finance and transaction analyst

Merger-focused pivot with asset divestiture and a limited cash runway into Q4 2026.

Pulmatrix intends to divest its iSPERSE™ patent portfolio and three clinical programs as part of a proposed merger with Cullgen, shifting the combined company to Cullgen’s targeted protein degradation business. The Company reported $4.8 million in cash as of September 30, 2025 and expects this to fund operations into Q4 2026, while revenues fell to zero for the quarter and operating expenses declined following program wind-downs.

The deal’s completion depends on Nasdaq listing approval and China Security Regulatory Commission clearance, which are explicit closing conditions and therefore key execution risks. The decision to divest core inhalation assets materially changes the combined company’s asset base and potential revenue streams until any sale or monetization occurs.

Watch near-term milestones: Nasdaq approval and regulatory clearances, any definitive asset sale terms, and cash-burn trajectory through Q4 2026. These items will determine whether the transaction preserves value or forces accelerated asset sales under constrained liquidity.

Clinical and IP portfolio analyst

Divestiture announced of a broad inhalation IP estate and Phase 2-ready migraine asset; clinical value contingent on buyers.

The iSPERSE™ portfolio comprises about 146 granted patents and ~50 pending applications globally, and includes three clinical programs: a Phase 2‑ready PUR3100 for acute migraine, PUR1800 with supportive Phase 1b safety data for AECOPD, and PUR1900 with partner-led activity outside the U.S. The press release confirms an FDA ‘‘study may proceed’’ letter for the PUR3100 Phase 2 IND, which preserves its near-term clinical optionality.

Divestiture transfers clinical and regulatory progress to prospective acquirers; the portfolio’s value depends on who acquires it and on how the Phase 2 PUR3100 trial is run. Important near-term items to follow are any announced asset sale agreements, retained royalty terms (notably the 2% royalty from Cipla outside the U.S.), and confirmation that the PUR3100 Phase 2 protocol proceeds under new ownership.

As part of the proposed merger, Pulmatrix currently intends to divest its assets including its proprietary dry powder delivery technology, iSPERSE™, which enables delivery of small- or large-molecule drugs to the lungs by inhalation to treat migraine and respiratory diseases

FRAMINGHAM, Mass., Oct. 16, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced third quarter financial results for 2025 and provided a corporate update.

Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the third quarter has been to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies for the treatment of pain, cancer and other diseases. If consummated, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain, which Cullgen recently announced has completed enrollment. As part of the proposed merger, Pulmatrix is currently in a process to potentially divest its patent portfolio encompassing our iSPERSE™ technology, as well as three related clinical programs, including our Phase 2 ready acute migraine program."

Proposed Merger with Cullgen

As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger").

Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025, and declared effective on May 9, 2025.

On June 16, 2025, the Company held a special meeting in lieu of the annual meeting of Pulmatrix stockholders, at which the Company's stockholders approved the Merger and related proposals. The Closing is subject to other customary closing conditions, including Nasdaq's approval of the listing of the shares of Pulmatrix common stock to be issued in connection with the Merger and approval from the China Security Regulatory Commission.  

If the proposed Merger is completed, the business of Cullgen will continue as the business of the combined company.

Pulmatrix Currently Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology

iSPERSE™ Technology

• iSPERSE™ particles are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases.
• As of September 30, 2025, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 146 granted patents, 18 of which are U.S.-granted patents, plus approximately 50 pending patent applications in the U.S. and other jurisdictions.

PUR3100

• PUR3100 is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE™ dry powder inhalation technology for the treatment of acute migraine and is a Phase 2-ready asset with a Food and Drug Administration acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine.
• The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in the peer-reviewed publication, Headache: The Journal of Head and Face Pain. The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously ("IV") administered DHE dose group.

PUR1800

• PUR1800 is a Narrow Spectrum Kinase Inhibitor ("NSKI"), engineered with our iSPERSE™ technology, for the treatment of acute exacerbations in chronic obstructive pulmonary disease ("AECOPD"). In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for AECOPD, indicating PUR1800 was well-tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases.
• In 2024, Pulmatrix published an abstract titled "Ex vivo evaluation of the potential for Narrow Spectrum Kinase inhibitors as a treatment for Idiopathic Pulmonary Fibrosis".

PUR1900

• PUR1900 is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole being investigated for various indications. The Company and its partner, Cipla, wound down a Phase 2b trial that the Company was operating in 2024. Cipla has continued clinical development outside the United States and in 2025 advised Pulmatrix that they have completed their Phase 2 study in India and have been approved by India's Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial.
• Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States should Cipla successfully market PUR1900 outside the United States. Within the United States, the Company and Cipla will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need.

Third Quarter 2025 Financial Results 

Revenues decreased approximately $0.4 million to $0 for the three months ended September 30, 2025, compared to $0.4 million for the three months ended September 30, 2024. The decrease is primarily related to completion of the wind down of the PUR1900 Phase 2b clinical trial during the year ended December 31, 2024.

Research and development expenses decreased approximately $0.8 million to less than $0.1 million for the three months ended September 30, 2025, compared to $0.8 million for the three months ended September 30, 2024. The decrease was primarily due to winding down the PUR1900 Phase 2b clinical trial, disposal of the Company's lab and facilities lease and employee terminations.

General and administrative expenses decreased approximately $1.4 million to $0.9 million for the three months ended September 30, 2025, compared to $2.2 million for the three months ended September 30, 2024. The decrease was primarily due to decreased employment and other operating costs due to the previously mentioned winddown, partially offset by incurred costs related to the proposed Merger.

The Company's total cash and cash equivalents balance as of September 30, 2025, was $4.8 million. The Company anticipates that its cash position, based on current operational efficiencies and prioritization of spending, is sufficient to fund its operations into the fourth quarter of 2026.

 

PULMATRIX, INC. Consolidated Balance Sheets (in thousands, except share and per share data)
		September 30, 2025				December 31, 2024
		(unaudited)
Assets
Current assets:
Cash and cash equivalents		$	4,794			$	9,521
Prepaid expenses and other current assets			178				399
Total current assets			4,972				9,920
Long-term restricted cash			10				10
Other long-term assets			-				13
Total assets		$	4,982			$	9,943
Liabilities and stockholders' equity
Current liabilities:
Accounts payable		$	69			$	809
Accrued expenses and other current liabilities			180				120
Total current liabilities			249				929
Warrant liability			-				67
Total liabilities			249				996
Stockholders' equity:
Preferred Stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at September 30, 2025 and December 31, 2024			-				-
Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 shares issued and outstanding at September 30, 2025 and December 31, 2024			-				-
Additional paid-in capital			306,123				306,103
Accumulated deficit			(301,390)				(297,156)
Total stockholders' equity			4,733				8,947
Total liabilities and stockholders' equity		$	4,982			$	9,943

 

PULMATRIX, INC. Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2025				2024				2025				2024
Revenues		$	-				366				-				7,803
Operating expenses:
Research and development			8				814				41				7,160
General and administrative			858				2,209				4,220				5,836
Loss on MannKind Transaction			-				-				-				2,618
Total operating expenses			866				3,023				4,261				15,614
Loss from operations			(866)				(2,657)				(4,261)				(7,811)
Other income (expense):
Interest income			30				101				124				394
Fair value adjustment of warrants			-				-				67				-
Other expense, net			(41)				(31)				(164)				(156)
Total other income (expense), net			(11)				70				27				238
Net loss		$	(877)				(2,587)				(4,234)				(7,573)
Net loss per share attributable to common stockholders – basic and diluted		$	(0.24))	)			(0.71)				(1.16))	)			(2.07)
Weighted average common shares outstanding – basic and diluted			3,652,285				3,652,285				3,652,285				3,652,285

About Pulmatrix, Inc.
Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for central nervous system ("CNS") disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease ("COPD") and allergic bronchopulmonary aspergillosis ("ABPA"). Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes.

About iSPERSE™ Technology
Pulmatrix's innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE™ is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE™ can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases.

For more on the Company's inhaled product candidates please visit:
https://www.pulmatrix.com/pipeline.html.

Forward-Looking Statements
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that," "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the consummation of and the exact timing of the proposed Merger with Cullgen, the receipt of applicable regulatory approvals in connection with the proposed Merger with Cullgen, and satisfaction of closing conditions thereunder, among others; the Company's ability to divest its clinical assets on terms favorable to the Company, or at all, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market; the Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, including the proposed Merger with Cullgen, is set forth in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:
Chuck Padala
Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com 

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SOURCE Pulmatrix Inc.

FAQ

What did Pulmatrix (PULM) report for cash and runway on Oct 16, 2025?

Pulmatrix reported $4.8M cash as of Sept 30, 2025 and expects this to fund operations into Q4 2026.

What is the status of Pulmatrix's PUR3100 program (PULM)?

PUR3100 is Phase 2‑ready with an FDA IND accepted and a ‘study may proceed’ letter to start a Phase 2 acute migraine trial.

How did Pulmatrix (PULM) perform in Q3 2025 on revenue and net loss?

Pulmatrix reported Q3 revenue $0 (down ~$0.4M YoY) and a net loss of $0.877M for the quarter.

What assets is Pulmatrix planning to divest as part of the proposed merger (PULM)?

Pulmatrix intends to potentially divest its iSPERSE dry powder delivery technology and three related clinical programs including PUR3100.

Has the Pulmatrix merger with Cullgen (PULM) been approved by shareholders?

Yes, Pulmatrix stockholders approved the merger at a special meeting on June 16, 2025, but closing still requires regulatory and Nasdaq approvals.

What royalties does Pulmatrix retain on PUR1900 sales outside the U.S.?

Pulmatrix will receive a 2% royalty on potential future net sales of PUR1900 by Cipla outside the United States.