Pulmatrix, Inc 10-K for FY2025

Pulmatrix, Inc. (PULM)

10-K 2026-02-26 For: 2025-12-31

Added on April 08, 2026

About this 10-K

Pulmatrix, Inc filed this 10-K on February 26, 2026, covering the fiscal year ended December 31, 2025 (FY2025).

Headline figures

Fiscal year ended December 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $5.16M; compared with a net loss of $9.56M a year earlier
Diluted EPS: -$1.41; compared with -$2.62 a year earlier

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Delaware		46-1821392
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

945 Concord Street, Suite 1217 Framingham, MA		01701
(Address of principal executive offices)		(Zip Code)

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		PULM		The Nasdaq Stock Market LLC

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		Emerging growth company	☐

		Page No.

Forward-Looking Statements		1

PART I

Item 1.	Business.	2

Item 1A.	Risk Factors.	20

Item 1B.	Unresolved Staff Comments.	54

Item 1C.	Cybersecurity.	54

Item 2.	Properties.	55

Item 3.	Legal Proceedings.	55

Item 4.	Mine Safety Disclosures.	55

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.	56

Item 6.	Reserved.	56

Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	56

Item 7A.	Quantitative and Qualitative Disclosures About Market Risk.	64

Item 8.	Financial Statements and Supplementary Data.	64

Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.	65

Item 9A.	Controls and Procedures.	65

Item 9B.	Other Information.	66

Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.	66

PART III

Item 10.	Directors, Executive Officers and Corporate Governance.	67

Item 11.	Executive Compensation.	74

Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.	76

Item 13.	Certain Relationships and Related Transactions, and Director Independence.	77

Item 14.	Principal Accountant Fees and Services.	77

PART IV

Item 15.	Exhibits, Financial Statement Schedules.	79

Item 16.	Form 10-K Summary.	79

Signatures		84

	●	the risk that the conditions to closing of the potential Merger with Cullgen (each as defined herein) are not satisfied, including failure to obtain approval from the CSRC (as defined herein);

	●	the risk that we are unable to meet expectations regarding the timing and completion of the Merger;

	●	uncertainties as to the timing and costs of the consummation of the transactions contemplated by the Merger Agreement (as defined herein);

	●	the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Merger Agreement;

	●	the outcome of any legal proceedings that may be instituted against us, Cullgen, or any of each company’s respective directors or officers related to the Merger Agreement or the transactions contemplated thereby;

	●	should we resume development of our product candidates, our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue or complete our business objectives;

	●	should we resume development of our product candidates, our inability to carry out research, development and commercialization plans;

	●	should we resume development of our product candidates, our inability to manufacture our product candidates on a commercial scale on our own or in collaborations with third parties;

	●	should we resume development of our product candidates, our inability to complete preclinical testing and clinical trials as anticipated;

	●	should we resume development of our product candidates, our collaborators’ inability to successfully carry out their contractual duties;

	●	should we resume development of our product candidates, termination of certain license agreements;

	●	should we resume development of our product candidates, our ability to adequately protect and enforce rights to intellectual property, or defend against claims of infringement by others;

	●	should we resume development of our product candidates, difficulties in obtaining financing on commercially reasonable terms, or at all;

	●	should we resume development of our product candidates, intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution, personnel and resources than we do;

	●	should we resume development of our product candidates, entry of new competitors and products and potential technological obsolescence of our products;

	●	adverse market and economic conditions;

	●	our ability to maintain compliance with the listing standards of the Nasdaq Capital Market (“Nasdaq”);

	●	loss of one or more key executives; and

	●	should we resume development of our product candidates, difficulties in securing regulatory approval to market our product candidates.

	●	Pursue further clinical studies for PUR3100, an orally inhaled dihydroergotamine (“DHE”) including a Phase 2 clinical study for the treatment of acute migraine. We received Food and Drug Administration (“FDA”) acceptance of our Investigational New Drug Application (“IND”) and a “study may proceed” letter in September 2023, positioning PUR3100 as Phase 2-ready for potential financing or partnership discussions.

		We developed PUR3100, an iSPERSE™ formulation of DHE in 2020. We completed good laboratory practice (“GLP”) toxicology studies in 2021 and 2022. In 2022, we completed a Phase 1 study designed as a double-blinded trial to assess the safety, tolerability, and pharmacokinetics of three dose levels of single doses of inhaled PUR3100 with intravenous (“IV”) placebo, as compared to IV DHE (DHE mesylate injection) with inhaled placebo. On January 4, 2023, we announced the Phase 1 topline results, indicating that PUR3100 was safe and tolerated with fewer gastrointestinal side effects in all doses compared to IV DHE. PUR3100 showed a five-minute T_max and C_max within the targeted therapeutic range for all three doses tested. The Phase 1 study data was presented at the American Headache Society 65th Annual Meeting in June 2023. In May 2024, we announced a peer-reviewed publication of Phase 1 clinical results in the publication Headache: The Journal of Head and Face Pain.

		In September 2023, we announced the FDA’s acceptance of an IND application for PUR3100 and receipt of a “study may proceed” letter for 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. Based on the rapid systemic exposure in the therapeutic range and the improved side effect profile relative to IV dosing, we believe the PUR3100 formulation of DHE may differentiate from approved DHE products or those in development. If effectiveness is demonstrated, PUR3100 may offer the convenience of being self-administered with a pharmacokinetic profile that may potentially provide rapid onset of action.

	●	Pursue partnership or other alternatives to monetize or advance PUR1800, focusing on the development of an orally inhaled kinase inhibitor for treatment of AECOPD.

		We completed preclinical safety studies for PUR1800, our iSPERSE^™ formulation of RV1162, in 2018 and advanced our formulation and process development efforts to support clinical testing in stable moderate-severe COPD patients. We completed a Phase 1b safety, tolerability, and pharmacokinetics clinical study of PUR1800 for subjects with stable moderate-severe COPD and received topline data from the Phase 1b clinical study in the first quarter of 2022. We analyzed data from the completed Phase 1b clinical study of PUR1800 for AECOPD and presented study results at the American Academy of Allergy, Asthma & Immunology (AAAAI) conference in the first quarter of 2023. The results indicated PUR1800 was safe and 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”.

	●	Capitalize on our proprietary iSPERSE™ technology and our expertise in inhaled therapeutics and particle engineering to identify new product candidates for prevention and treatment of diseases, including those with important unmet medical needs.

		To add additional inhaled therapeutics to our development pipeline and facilitate additional collaborations, we are leveraging our iSPERSE™ technology and our expertise in inhaled therapeutics and particle engineering to identify potential product candidates.

	●	Invest in protecting and expanding our intellectual property portfolio and file for additional patents to strengthen our intellectual property rights.

		The status of our patent portfolio changes frequently in the ordinary course of patent prosecution. As of December 31, 2025, our patent portfolio related to iSPERSE^™ included approximately 149 granted patents, 18 of which are granted US patents, with expiration dates from 2026 to 2043, and approximately 48 additional pending patent applications in the US and other jurisdictions. Our in-licensed portfolio related to kinase inhibitors included approximately 284 granted patents, 33 of which are granted US patents, with expiration dates from 2029 to 2035, and approximately 11 additional pending patent applications in the US and other jurisdictions. We have national phase applications pending in Australia, Brazil, Canada, China, Europe, Israel, India, Japan, Korea, Mexico, New Zealand, Russia, Hong Kong and the United States that cover certain formulations and methods of use relevant to our PUR3100 program.

	●	Seek partnerships and license agreements to support the product development and commercialization of our product candidates.

		In order to advance our clinical programs, we may seek partners or licensees in areas of pharmaceutical and clinical development.

	●	Completion of preclinical laboratory and animal testing;

	●	The submission to the FDA of an IND application, which must be evaluated, for safety and quality of scientific evaluation, and found acceptable by the FDA before human clinical trials may commence;

	●	Performance of adequate and well-controlled human clinical trials in accordance with the protocols described in the accepted IND, as well as FDA’s IND regulations to establish the safety and efficacy of the proposed drug for its intended use; and

	●	Submission and approval of an NDA.

	●	There is no assurance when or if the Merger will be completed. Any delay in completing the Merger may substantially reduce the potential benefits that we and Cullgen expect to obtain from the Merger;

	●	We may engage in the sale, license, transfer, disposition, divestiture or other monetization transaction Pulmatrix Legacy Business;

	●	The issuance of shares of our common stock to Cullgen stockholders in the Merger will substantially dilute the voting power of our current stockholders. Having a minority share position will reduce the influence that current stockholders have on our management;

	●	The issuance, or expected issuance, of our common stock in connection with the Merger could decrease the market price of our common stock;

	●	The intended benefits of the Merger may not be realized;

	●	Because the lack of a public market for Cullgen common stock makes it difficult to evaluate the fairness of the Merger, Cullgen stockholders may receive consideration in the Merger that is greater than or less than the fair market value of Cullgen common stock;

	●	Transfers of the Combined Company’s securities utilizing Rule 144 of the Securities Act may be limited;

	●	Our expected disposal of our historical assets and operations in connection with our proposed Merger with Cullgen will make us a shell company. As a result, we will be subject to more stringent reporting requirements, offering limitations and resale restrictions;

	●	Directors and officers of us and Cullgen may have interests in the Merger that are different from, or in addition to, those of our stockholders and Cullgen stockholders generally that may influence them to support or approve the Merger;

	●	If the Merger is completed, Cullgen executive officers and Cullgen appointees to the Combined Company board of directors will have the ability to significantly influence the Combined Company’s management and business affairs, as well as matters submitted to the Combined Company board of directors or stockholders for approval, especially if they decide to act together with the current Cullgen stockholders;

	●	The announcement and pendency of the Merger could have an adverse effect on our or Cullgen’s business, financial condition, results of operations or business prospects;

	●	The rights of Cullgen stockholders who become our stockholders in the Merger and our stockholders following the Merger will be governed by the Certificate of Incorporation, as amended;

	●	The Exchange Ratio is not adjustable based on the market price of our common stock, so the Merger consideration at the Closing may have a greater or lesser value than at the time the Merger Agreement was signed;

	●	We are expected to incur substantial expenses related to the Merger with Cullgen;

	●	Failure to complete the Merger could negatively affect the value of our common stock and the future business and financial results of both us and Cullgen;

	●	The Merger is expected to result in a limitation on the Combined Company’s ability to utilize its net operating loss carryforward;

	●	The analysis received by our board of directors from Lucid Capital Markets, LLC has not been, and is not expected to be, updated to reflect changes in circumstances that may have occurred since the date of the analysis;

	●	The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes or other causes;

	●	We and Cullgen may become involved in securities litigation or stockholder derivative litigation in connection with the Merger, and this could divert the attention of our and Cullgen’s management and harm the Combined Company’s business, and insurance coverage may not be sufficient to cover all related costs and damages;

	●	We have never paid and, except the potential Cash Dividend in connection with the Merger, do not intend to pay any cash dividends in the foreseeable future;

	●	We are substantially dependent on our remaining employees, key contractors and consultants to facilitate the consummation of the Merger.

	●	The proposed reverse stock split may not increase the Combined Company’s common stock price over the long term;

	●	The proposed reverse stock split would have the effect of increasing the amount of common stock that the Combined Company is authorized to issue without further approval by the Combined Company stockholders;

	●	The proposed reverse stock split may decrease the liquidity of our common stock;

	●	The proposed reverse stock split may lead to a decrease in overall market capitalization of the Combined Company.

	●	We have a history of net losses and may experience future losses;

	●	We will need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests;

	●	We have historically been a clinical development stage biopharmaceutical company and have never been profitable;

	●	All of our product candidates are still under development, and there can be no assurance of successful commercialization of any of our products;

	●	Drug development is a long, expensive, and inherently uncertain process with a high risk of failure at every stage of development, and results of earlier studies and trials may not be predictive of future trial results;

	●	If our collaborators are not successful, we may not effectively develop and market some of our therapeutic candidates;

	●	We may not be able to attract, retain, or manage highly qualified personnel, which could adversely impact our business;

	●	If the third parties on which we rely to conduct our clinical trials, to manufacture clinical trial materials, and to assist us with preclinical development do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval for, or to commercialize, our products;

	●	We rely on third-party contract vendors to manufacture and supply us with high quality active pharmaceutical ingredients and manufacture our therapeutic candidates in the quantities we require on a timely basis;

	●	Supply chain and shipping disruptions may result in shipping delays, a significant increase in shipping costs, and could increase product costs and result in lost sales and reputational damage, which may have a material adverse effect on our business, operating results and financial condition;

	●	We may not be successful in negotiating for an appropriate price in a future sale or assignment of our rights related to our current drug candidates;

	●	Our failure to successfully acquire, develop and market additional drug candidates or approved drug products could impair our ability to grow;

	●	Our business strategy may include entry into additional collaborative or license agreements. We may not be able to enter into collaborative or license agreements or may not be able to negotiate commercially acceptable terms for these agreements;

	●	We may be subject to claims that our employees, independent consultants or agencies have wrongfully used or inadvertently disclosed confidential information of third parties;

	●	Market and economic conditions may negatively impact our business, financial condition and share price;

	●	If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us;

	●	Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations;

	●	Our business is subject to cybersecurity risks.

	●	We cannot be certain that any of our current and future product candidates will receive regulatory approval, and without regulatory approval we will not be able to market our product candidates;

	●	We have limited experience in filing and pursuing applications necessary to gain regulatory approvals, which may impede our ability to obtain timely approvals from the U.S. Food and Drug Administration (“FDA”) or foreign regulatory agencies, if at all;

	●	Any failure by us to comply with existing or future regulations could harm our reputation and operating results;

	●	We and our third-party manufacturers are, and will be, subject to regulations of the FDA and other foreign regulatory authorities;

	●	Even if we obtain regulatory approvals, our therapeutic candidates will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and applicable foreign laws, regulations and guidelines, we could lose those approvals, and our business would be seriously harmed;

	●	Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading;

	●	If we fail to comply with federal or state “fraud and abuse” laws, the failure to comply with these laws may adversely affect our business, financial condition and results of operations;

	●	Legislative or regulatory reform of the U.S. healthcare system may adversely affect our business.

	●	We will be required to raise additional capital to fund our operations, and we may not be able to continue as a going concern if we are unable to do so;

	●	Our long-term capital requirements are subject to numerous risks;

	●	We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.

	●	We may be unable to adequately protect or enforce our rights to intellectual property, causing us to lose valuable rights. Loss of patent rights may lead us to lose market share and anticipated profits;

	●	If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us;

	●	Legal proceedings or third-party claims of intellectual property infringement and other challenges may require us to spend substantial time and money and could prevent us from developing or commercializing our product candidates;

	●	We may be subject to other patent-related litigation or proceedings that could be costly to defend and uncertain in their outcome;

	●	Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements;

	●	If we fail to comply with our obligations under our license agreements, we could lose the rights to intellectual property that is important to our business;

	●	We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

	●	The price of our common stock is subject to fluctuation and has been and may continue to be volatile;

	●	Financial reporting obligations of being a public company in the United States are expensive and time-consuming, and our management may be required to devote substantial time to compliance matters;

	●	We may be at risk of securities class action litigation;

	●	In the event that we fail to satisfy any of the listing requirements of Nasdaq, our common stock may be delisted, which could affect our market price and liquidity;

	●	We may issue additional equity securities in the future, which could result in dilution to existing investors;

	●	We currently take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive to investors;

	●	Anti-takeover provisions under Delaware corporate law may make it difficult for our stockholders to replace or remove our board of directors and could deter or delay third parties from acquiring us, which may be beneficial to our stockholders;

	●	Protective provisions in our charter and bylaws could prevent a takeover which could harm our stockholders.

	●	that senior management’s attention may be diverted from the management of our current operations and development of our products and Cullgen’s current operations and development of its products;

	●	costs and expenses associated with any undisclosed or potential liabilities; and

	●	unforeseen difficulties may arise in integrating Cullgen’s and our business in the Combined Company.

	●	the Combined Company will need to file a Form 8-K to report the Form 10 type information after Closing with the SEC reflecting its status as an entity that is not a shell company;

	●	We are not, and the Combined Company will not be, eligible to use a Form S-3 until 12 full calendar months after Closing;

	●	the Combined Company will need to wait at least 60 calendar days after closing to file a Form S-8 for any equity plans or awards;

	●	the Combined Company will be an “ineligible issuer” for three years following the closing, which will prevent the Combined Company from (i) incorporating by reference in its Form S-1 filings, (ii) using a free writing prospectus, or (iii) taking advantage of well-known seasoned issuer status despite its public float;

	●	Our or Cullgen’s current and prospective employees could experience uncertainty about their future roles within the Combined Company, and this uncertainty might adversely affect our or Cullgen’s ability to retain, recruit and motivate key personnel;

	●	the attention of our or Cullgen’s management may be directed towards the completion of the Merger and other transaction-related considerations and may be diverted from our or Cullgen’s day-to-day business operations, as applicable, and matters related to the Merger may require commitments of time and resources that could otherwise have been devoted to other opportunities that might have been beneficial to us or Cullgen, as applicable;

	●	customers, prospective customers, suppliers, collaborators and other third parties with business relationships with us or Cullgen may decide not to renew or may decide to seek to terminate, change or renegotiate their relationships with us or Cullgen as a result of the Merger, whether pursuant to the terms of their existing agreements with us or Cullgen; and

	●	the market price of our common stock may decline to the extent that the current market price reflects a market assumption that the proposed Merger will be completed.

	●	diversion of management focus and resources from operational matters and other strategic opportunities while working to implement the Merger;
	●	reputational harm due to the adverse perception of any failure to successfully complete the Merger; and
	●	having to pay certain costs relating to the Merger, such as legal, accounting, financial advisory, filing and printing fees.

	●	changes or events affecting the industries in which the parties operate generally;
	●	any natural disaster, calamity or epidemics, pandemics or other force majeure events or any act or threat of terrorism or war, any armed hostilities or terrorist events anywhere in the world or any governmental or other response or reaction to any of the foregoing; or
	●	changes in U.S. GAAP or other applicable law or the interpretation thereof.

	●	advancing the research and development of our therapeutic candidates;

	●	investing in protecting and expanding our intellectual property portfolio, including filing for additional patents to strengthen our intellectual property rights;

	●	hiring and retaining qualified management and key employees;

	●	responding to competitive pressures; and

	●	maintaining compliance with applicable laws.

	●	be shown to be ineffective or to cause harmful side effects during preclinical testing or clinical trials;

	●	fail to receive regulatory approval on a timely basis or at all;

	●	be difficult to manufacture on a large scale;

	●	not be economically viable;

	●	not be prescribed by doctors or accepted by patients;

	●	fail to receive a sufficient level of reimbursement from government, insurers or other third-party payors; or

	●	infringe on intellectual property rights of any other party.