PART I—FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the interim period [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's organization, accounting policies, and specific financial line items. It highlights the company's financial position and performance for the periods ended June 30, 2025, and December 31, 2024 [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%2C%20and%20December%2031%2C%202024) This section presents the company's financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 (unaudited, in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------- | :------------------------------- | | Cash and cash equivalents | $5,825 | $9,521 | | Total current assets | $6,142 | $9,920 | | Total assets | $6,152 | $9,943 | | Total current liabilities | $548 | $929 | | Warrant liability | $- | $67 | | Total liabilities | $548 | $996 | | Total stockholders' equity | $5,604 | $8,947 | - **Total assets** decreased by **$3,791k** from December 31, 2024, to June 30, 2025[11](index=11&type=chunk) - **Cash and cash equivalents** decreased by **$3,696k** during the six months ended June 30, 2025[11](index=11&type=chunk) [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%2C%20and%202024) This section outlines the company's financial performance, including revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Revenues | $- | $1,552 | $- | $7,437 | | R&D expenses | $14 | $2,834 | $33 | $6,346 | | G&A expenses | $1,534 | $2,001 | $3,362 | $3,627 | | Loss on MannKind Transaction | $- | $2,618 | $- | $2,618 | | Net loss | $(1,549) | $(5,811) | $(3,357) | $(4,986) | | Net loss per share (basic & diluted) | $(0.42) | $(1.59) | $(0.92) | $(1.37) | - **Revenues** decreased significantly to **$0** for both the three and six months ended June 30, 2025, compared to **$1,552k** and **$7,437k** respectively in 2024[14](index=14&type=chunk) - **Research and development expenses** saw a substantial reduction, from **$2,834k** to **$14k** for the three months and from **$6,346k** to **$33k** for the six months ended June 30, 2025[14](index=14&type=chunk) [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%2C%20and%202024) This section details changes in stockholders' equity, including net loss and stock-based compensation, for the three and six months ended June 30, 2025, and 2024 | Metric | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | | :---------------------- | :--------------------------- | :--------------------------- | | Total Stockholders' Equity | $5,604 | $13,310 | | Accumulated Deficit | $(300,513) | $(292,583) | | Stock-based compensation | $14 (6M) | $301 (6M) | - **Total stockholders' equity** decreased from **$8,947k** at January 1, 2025, to **$5,604k** at June 30, 2025, primarily due to **net losses**[17](index=17&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%2C%20and%202024) This section presents the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(3,696) | $(6,396) | | Net cash used in investing activities | $- | $(398) | | Net decrease in cash, cash equivalents, and restricted cash | $(3,696) | $(6,794) | | Cash, cash equivalents and restricted cash — end of period | $5,835 | $13,851 | - **Net cash used in operating activities** decreased by **$2,700k**, from **$(6,396)k** in 2024 to **$(3,696)k** in 2025[20](index=20&type=chunk) - No cash was used in investing activities for the six months ended June 30, 2025, compared to **$(398)k** in the prior year[20](index=20&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements, covering accounting policies, organization, and specific financial line items [1. Organization](index=8&type=section&id=1.%20Organization) This note describes Pulmatrix as a biopharmaceutical company and details the ongoing merger agreement with Cullgen Inc., including key terms and conditions - **Pulmatrix** is a biopharmaceutical **Company** focused on developing novel inhaled therapeutic products using its patented **iSPERSE™ technology**[23](index=23&type=chunk) - The **Company** entered into a **Merger Agreement** with **Cullgen Inc.** on November 13, 2024, which was amended on April 7, 2025[24](index=24&type=chunk) - Upon closing, **pre-Merger Cullgen stockholders** are expected to own approximately **96.4%** and **pre-Merger Pulmatrix stockholders** **3.6%** of the combined **Company** on a fully-diluted basis[29](index=29&type=chunk) - The **Merger** is subject to customary closing conditions, including **Nasdaq listing approval** and approval from the **China Security Regulatory Commission (CSRC)**. The term was extended to **October 12, 2025**, due to pending **CSRC** approval[31](index=31&type=chunk) - If the **Merger** is not consummated, the **Company's** board of directors may decide to pursue a dissolution and liquidation[34](index=34&type=chunk) [2. Summary of Significant Accounting Policies and Recent Accounting Standards](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies%20and%20Recent%20Accounting%20Standards) This note outlines the basis of financial statement preparation, significant accounting policies, and the impact of recent accounting pronouncements - The condensed consolidated financial statements are unaudited and prepared in accordance with **SEC** rules and **U.S. GAAP**, with certain information condensed or omitted[35](index=35&type=chunk)[36](index=36&type=chunk) - The **Company's** future **operations** are highly dependent on the success of the **Merger**. If not consummated, existing cash is expected to fund **operations** for at least twelve months, but substantial additional funding would be needed for program development[37](index=37&type=chunk) - No **revenue** was recognized for the three and six months ended June 30, 2025. For the same periods in 2024, **revenue** from one customer accounted for **61%** and **89%** of total **revenue**, respectively[42](index=42&type=chunk) - The **Company** is evaluating the impact of new accounting pronouncements **ASU 2023-09 (Income Taxes)** and **ASU 2024-03 (Expense Disaggregation Disclosures)** on its annual and consolidated financial statements[45](index=45&type=chunk)[46](index=46&type=chunk) [3. Prepaid Expenses and Other Current Assets](index=11&type=section&id=3.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note provides a breakdown of prepaid expenses and other current assets, highlighting changes between reporting periods | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------ | :--------------------------- | :------------------------------- | | Insurance | $228 | $200 | | Software and hosting costs | $4 | $19 | | Other | $85 | $180 | | **Total** | **$317** | **$399** | - **Total prepaid expenses** and other current assets decreased by **$82k** from **$399k** at December 31, 2024, to **$317k** at June 30, 2025[48](index=48&type=chunk) [4. Accrued Expenses and Other Current Liabilities](index=11&type=section&id=4.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note details the composition and changes in accrued expenses and other current liabilities, including legal and patent costs | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------ | :--------------------------- | :------------------------------- | | Legal and patents | $120 | $11 | | Wages and incentives | $30 | $38 | | Other | $14 | $71 | | **Total** | **$164** | **$120** | - **Total accrued expenses** and other current liabilities increased by **$44k** from **$120k** at December 31, 2024, to **$164k** at June 30, 2025, primarily due to an increase in legal and patent expenses[49](index=49&type=chunk) [5. Common Stock](index=12&type=section&id=5.%20Common%20Stock) This note describes the company's common stock, including its At-The-Market sales agreement and share issuance activities - The **Company** has an **At-The-Market (ATM) Sales Agreement** to issue and sell up to **$20.0 million** of **common stock**, subject to public float limitations[50](index=50&type=chunk) - No **shares** of **common stock** were sold under the **ATM Sales Agreement** during the six months ended June 30, 2025, and 2024[52](index=52&type=chunk) [6. Warrants](index=12&type=section&id=6.%20Warrants) This note details the company's outstanding warrants, their classification, exercise prices, and the re-measurement of warrant liability - The **warrant liability** was re-measured to **$0** as of June 30, 2025, resulting in a **$67k** gain recorded in the consolidated statements of **operations** for the six months ended June 30, 2025[53](index=53&type=chunk) | Classification | Adjusted Exercise Price | Expiration Date | Number of Shares Underlying Warrants | | :------------- | :---------------------- | :-------------- | :----------------------------------- | | Equity | $14.99 | Dec 15, 2026 | 36,538 | | Equity | $13.99 | Dec 17, 2026 | 281,047 | | Equity | $49.99 | Feb 11, 2026 | 65,003 | | Liability | $35.99 | July 14, 2025 | 90,743 | | Liability | $44.99 | July 14, 2025 | 10,939 | | Liability | $35.99 | July 14, 2025 | 77,502 | | Liability | $44.99 | July 14, 2025 | 21,846 | | Liability | $35.99 | July 14, 2025 | 334,800 | | **Total** | | | **918,418** | - **Warrants** to purchase up to **15,955 shares** of **common stock** expired during the six months ended June 30, 2025[55](index=55&type=chunk) [7. Stock-based Compensation](index=13&type=section&id=7.%20Stock-based%20Compensation) This note outlines the company's stock-based compensation plan, available shares for grant, and the expenses recognized for stock-based awards - As of June 30, 2025, **963,854 shares** remained available for future grant under the Incentive Plan[56](index=56&type=chunk) - No options were granted or exercised during the six months ended June 30, 2025[57](index=57&type=chunk) | Expense Category | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------ | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development | $- | $29 | $- | $145 | | General and administrative | $6 | $74 | $14 | $156 | | **Total** | **$6** | **$103** | **$14** | **$301** | [8. Commitments and Contingencies](index=13&type=section&id=8.%20Commitments%20and%20Contingencies) This note discloses the company's material noncancellable commitments and any pending legal proceedings - As of June 30, 2025, the **Company** had no material noncancellable commitments related to **research and development activities**[59](index=59&type=chunk) - The **Company** is not aware of any pending **legal proceedings** that would reasonably be expected to have a material impact on its financial position or results of **operations**[60](index=60&type=chunk) [9. Income Taxes](index=13&type=section&id=9.%20Income%20Taxes) This note explains the company's income tax position, including the absence of tax expense due to operating losses and the valuation allowance against deferred tax assets - The **Company** had no **income tax expense** for the three and six months ended June 30, 2025, and 2024, due to **operating losses** incurred since inception[61](index=61&type=chunk) - A full valuation allowance was recorded against deferred tax assets as of June 30, 2025, and December 31, 2024, as it is more likely than not that the **Company** will not recognize the benefits of these assets[62](index=62&type=chunk) - The **Company** has no material uncertain tax positions as of June 30, 2025, and December 31, 2024[63](index=63&type=chunk) [10. Net Loss Per Share](index=14&type=section&id=10.%20Net%20Loss%20Per%20Share) This note details the calculation of basic and diluted net loss per share, including the impact of potentially dilutive securities - Basic and diluted **net loss per share** were the same for the three and six months ended June 30, 2025, and 2024, as the effect of potentially dilutive securities would have been anti-dilutive[65](index=65&type=chunk) | Potentially Dilutive Securities | Three and Six Months Ended June 30, 2025 | Three and Six Months Ended June 30, 2024 | | :------------------------------ | :--------------------------------------- | :--------------------------------------- | | Options to purchase common stock | 33,858 | 311,437 | | Warrants to purchase common stock | 918,418 | 1,001,048 | | **Total** | **952,276** | **1,312,485** | [11. Segment Reporting](index=14&type=section&id=11.%20Segment%20Reporting) This note clarifies that the company operates in a single reportable segment and how the chief operating decision maker assesses performance - The **Company** operates in a single reportable segment[66](index=66&type=chunk) - The chief executive officer, as the chief operating decision maker, reviews financial information on a consolidated basis and uses **net loss**, **operating forecasts**, and clinical results to assess financial performance and allocate resources[67](index=67&type=chunk) [12. Subsequent Events](index=14&type=section&id=12.%20Subsequent%20Events) This note discloses events occurring after the balance sheet date that may require adjustment or disclosure in the financial statements - The **Company** has evaluated all subsequent events through the date of financial statement issuance and concluded that no other events require disclosure beyond those already presented[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and liquidity. It discusses the ongoing merger with Cullgen, the strategic shift in product development, and the financial impact of these changes, including significant reductions in revenue and operating expenses [Forward-Looking Statements](index=15&type=section&id=Forward-Looking%20Statements) This section cautions readers about forward-looking statements, outlining inherent risks and uncertainties related to business plans and the merger - This report contains **forward-looking statements** regarding business plans, strategies, and anticipated **operating results**, which are subject to risks and uncertainties[70](index=70&type=chunk) - Key risks include the failure to satisfy closing conditions for the **Merger** with **Cullgen**, uncertainties in timing and costs, potential termination fees, and the outcome of **legal proceedings**[70](index=70&type=chunk) - Additional risks, should product development resume, include recurring losses, inability to carry out **R&D**, manufacturing challenges, and difficulties in obtaining financing[70](index=70&type=chunk)[76](index=76&type=chunk) [Overview](index=16&type=section&id=Overview) This section provides a high-level summary of the company's business, the ongoing merger agreement, strategic alternatives, and therapeutic candidates [Business](index=16&type=section&id=Business) This section describes Pulmatrix's core business as a biopharmaceutical company developing inhaled therapeutic products using its iSPERSE™ technology - **Pulmatrix** is a biopharmaceutical **Company** focused on developing novel inhaled therapeutic products for migraine and respiratory diseases using its patented **iSPERSE™ technology**[73](index=73&type=chunk) - The **iSPERSE™ dry powder delivery platform** is engineered for efficient dispersibility and delivery to the airways, suitable for various drug substances and inhaler technologies[74](index=74&type=chunk) - Advantages of **iSPERSE™** include reduced total inhaled powder mass, enhanced dosing efficiency, reduced cost of goods, and improved safety and tolerability profiles[75](index=75&type=chunk) [Merger Agreement and Strategic Alternatives](index=17&type=section&id=Merger%20Agreement%20and%20Strategic%20Alternatives) This section details the status of the merger agreement with Cullgen Inc., including approvals, potential outcomes, and strategic implications - **Pulmatrix** entered into a **Merger Agreement** with **Cullgen Inc.** on November 13, 2024, which was approved by **Pulmatrix stockholders** on June 16, 2025[77](index=77&type=chunk)[78](index=78&type=chunk) - The **Merger** is subject to **Nasdaq listing approval** and approval from the **China Security Regulatory Commission (CSRC)**. The term was extended to **October 12, 2025**, due to pending **CSRC** approval[78](index=78&type=chunk) - If the **Merger** is completed, **Cullgen's business** will continue as the combined **Company**, and **Pulmatrix** will seek opportunities to monetize its **iSPERSE™ technology** and existing clinical assets[79](index=79&type=chunk) - If the **Merger** is not consummated, the **Pulmatrix** board of directors may decide to pursue a dissolution and liquidation of the **Company**[80](index=80&type=chunk) [Therapeutic Candidates](index=17&type=section&id=Therapeutic%20Candidates) This section introduces the company's key therapeutic candidates, PUR3100, PUR1800, and PUR1900, and their development status [PUR3100](index=17&type=section&id=PUR3100) This section describes PUR3100, an inhaled DHE formulation for acute migraine, highlighting its clinical development and safety profile - **PUR3100** is an **iSPERSE™ formulation** of dihydroergotamine (**DHE**) for the treatment of acute migraine, aiming to be the first orally inhaled **DHE** treatment[91](index=91&type=chunk) - **Phase 1 study** results showed **PUR3100** was safe and well-tolerated, achieving peak exposures in the targeted therapeutic range with a **Tmax** of five minutes and a lower incidence of nausea and no vomiting compared to **IV DHE**[86](index=86&type=chunk)[95](index=95&type=chunk)[100](index=100&type=chunk) - The **FDA** accepted the **Investigational New Drug (IND) application** for **PUR3100** and issued a 'study may proceed' letter for a **Phase 2 study** in September 2023, but initiation is contingent on financing or partnership arrangements[87](index=87&type=chunk)[97](index=97&type=chunk) [PUR1800](index=18&type=section&id=PUR1800) This section details PUR1800, a Narrow Spectrum Kinase Inhibitor for AECOPD, outlining its clinical study results and potential for chronic dosing - **PUR1800** is a **Narrow Spectrum Kinase Inhibitor**, engineered with **iSPERSE™ technology**, being developed for the treatment of acute exacerbations in chronic obstructive pulmonary disease (**AECOPD**)[101](index=101&type=chunk) - A **Phase 1b clinical study** demonstrated **PUR1800** was well tolerated with no observed safety signals and resulted in low and consistent systemic exposure when administered via oral inhalation[104](index=104&type=chunk) - **Chronic toxicology studies** support the potential for chronic dosing of **PUR1800**, which could expand its potential indications beyond **AECOPD**[105](index=105&type=chunk) [PUR1900](index=21&type=section&id=PUR1900) This section describes PUR1900, an inhaled itraconazole formulation, and the development and commercialization agreement with Cipla - **Pulmatrix** has a **Development and Commercialization Agreement** with **Cipla** for **PUR1900**, an inhaled **iSPERSE™ formulation** of itraconazole for pulmonary indications like **ABPA**[107](index=107&type=chunk) - Under a recent amendment, **Cipla** exclusively handles development and commercialization outside the United States, bearing all costs and profits, with **Pulmatrix** receiving **2% royalties** on any potential future net sales by **Cipla** in those territories[108](index=108&type=chunk)[111](index=111&type=chunk) - **Cipla** has received approval to proceed with **Phase 3 trials** for inhaled itraconazole dry powder formulation outside the United States[111](index=111&type=chunk) [Financial Overview](index=21&type=section&id=Financial%20Overview) This section provides a summary of the company's financial performance, including revenues, research and development, and general and administrative expenses [Revenues](index=21&type=section&id=Revenues) This section discusses the company's revenue recognition, noting the absence of revenues for the current period and the source of past revenues - No **revenues** were recognized for the six months ended June 30, 2025[112](index=112&type=chunk) - **Revenues** for the three and six months ended June 30, 2024, were primarily from the **Cipla Agreement** related to the **PUR1900 program**, for which wind-down activities have been completed[112](index=112&type=chunk) [Research and Development Expenses](index=21&type=section&id=Research%20and%20Development%20Expenses) This section analyzes the significant decrease in research and development expenses and future funding requirements for program development - **Research and development expenses** decreased significantly due to reduced **employment** and **operating costs** following the **MannKind Transaction** and the completion of **PUR1900 wind-down activities**[115](index=115&type=chunk)[121](index=121&type=chunk)[125](index=125&type=chunk) - Future development of existing programs or new **iSPERSE™ opportunities** will require additional funding and is expected to utilize external resources[115](index=115&type=chunk)[116](index=116&type=chunk) [General and Administrative Expenses](index=22&type=section&id=General%20and%20Administrative%20Expenses) This section explains the changes in general and administrative expenses, attributing decreases to reduced operating costs and increases to merger-related expenses - **General and administrative expenses** decreased primarily due to reduced **employment** and other **operating costs**[122](index=122&type=chunk)[126](index=126&type=chunk) - This decrease was partially offset by costs related to the ongoing **Merger**[122](index=122&type=chunk)[126](index=126&type=chunk) [Critical Accounting Estimates](index=22&type=section&id=Critical%20Accounting%20Estimates) This section highlights the importance of management's estimates and judgments in financial reporting and the potential for actual results to differ - The preparation of condensed consolidated financial statements requires management to make estimates and judgments that affect reported amounts of assets, liabilities, **revenues**, and **expenses**[118](index=118&type=chunk) - Actual results may differ from these estimates under different assumptions or conditions[118](index=118&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of the company's financial performance for the three and six months ended June 30, 2025, and 2024 [Comparison of the Three Months Ended June 30, 2025, and 2024](index=23&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%2C%20and%202024) This section compares key financial metrics for the three-month periods, highlighting changes in revenues, expenses, and net loss | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :---------------------- | :------------------ | :------------------ | :-------------------- | | Revenues | $- | $1,552 | $(1,552) | | Research and development | $14 | $2,834 | $(2,820) | | General and administrative | $1,534 | $2,001 | $(467) | | Loss from operations | $(1,548) | $(5,901) | $4,353 | | Net loss | $(1,549) | $(5,811) | $4,262 | - **Revenues** decreased by **$1.6 million** due to the completion of the **PUR1900 Phase 2b clinical trial wind-down**[120](index=120&type=chunk) - **Research and development expenses** decreased by approximately **$2.8 million**, primarily due to reduced **employment costs** after the **MannKind Transaction** and lower costs for the **PUR1900 program**[121](index=121&type=chunk) [Comparison of the Six Months Ended June 30, 2025, and 2024](index=23&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%2C%20and%202024) This section compares key financial metrics for the six-month periods, detailing changes in revenues, expenses, and net loss | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :---------------------- | :------------------ | :------------------ | :-------------------- | | Revenues | $- | $7,437 | $(7,437) | | Research and development | $33 | $6,346 | $(6,313) | | General and administrative | $3,362 | $3,627 | $(265) | | Loss from operations | $(3,395) | $(5,154) | $1,759 | | Net loss | $(3,357) | $(4,986) | $1,629 | - **Revenues** decreased by **$7.4 million**, primarily due to the completion of the **PUR1900 Phase 2b clinical trial wind-down**[124](index=124&type=chunk) - **Research and development expenses** decreased by approximately **$6.3 million**, mainly due to reduced **employment costs** after the **MannKind Transaction** and lower costs for the **PUR1900**, **PUR3100**, and **PUR1800 programs**[125](index=125&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's financial liquidity, cash position, accumulated deficit, and future capital requirements - The **Company** incurred an **accumulated deficit** of **$300.5 million** through June 30, 2025[127](index=127&type=chunk) - **Cash and cash equivalents** totaled **$5.8 million** as of June 30, 2025[127](index=127&type=chunk) - Existing **cash and cash equivalents** are expected to fund corporate **operating expenses** for at least the next **12 months**, but additional capital will be needed for program development[129](index=129&type=chunk) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(3,696) | $(6,396) | | Net cash used in investing activities | $- | $(398) | | Net decrease in cash, cash equivalents, and restricted cash | $(3,696) | $(6,794) | - No **shares** of **common stock** were sold under the **At The Market Offering Agreement** during the six months ended June 30, 2025, and 2024[137](index=137&type=chunk) [Known Trends, Events and Uncertainties](index=25&type=section&id=Known%20Trends%2C%20Events%20and%20Uncertainties) This section discusses the inherent risks and uncertainties facing the biopharmaceutical industry, including the need for regulatory approvals and additional capital - The **Company** is subject to risks common in the biopharmaceutical industry, including those related to completing preclinical studies and clinical trials, receiving regulatory approvals, competition, and securing additional capital[138](index=138&type=chunk) - Should product development resume, significant additional **research and development efforts**, capital, personnel, infrastructure, and compliance reporting would be required[138](index=138&type=chunk) - It is uncertain when, if ever, the **Company** would realize **revenue** from product sales[138](index=138&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that the company has no material market risk disclosures to report - This item is not applicable to the **Company**[139](index=139&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the effectiveness of the company's disclosure controls and procedures and confirms no material changes in internal controls over financial reporting during the quarter [Disclosure Controls and Procedures](index=26&type=section&id=Disclosure%20Controls%20and%20Procedures) The Principal Executive Officer and Principal Financial Officer concluded that the Company's disclosure controls and procedures were effective as of June 30, 2025 - The **Principal Executive Officer** and **Principal Financial Officer** concluded that the **Company's disclosure controls and procedures** were effective as of June 30, 2025[140](index=140&type=chunk) - Management recognizes that controls provide only reasonable assurance and applies judgment in evaluating their cost-benefit relationship[141](index=141&type=chunk) [Changes in Internal Controls over Financial Reporting](index=26&type=section&id=Changes%20in%20Internal%20Controls%20over%20Financial%20Reporting) This section confirms no material changes in internal controls over financial reporting during the quarter ended June 30, 2025 - There were no changes in **internal control over financial reporting** during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, the **Company's internal control over financial reporting**[142](index=142&type=chunk) PART II—OTHER INFORMATION This section provides additional disclosures beyond the financial statements, covering legal proceedings, risk factors, equity sales, and other relevant information [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms that the company is not currently involved in any material legal proceedings or aware of any threatened litigation that would significantly impact its financial position or operations - The **Company** is not aware of any material **legal proceedings**, threatened or pending litigation, or proceedings contemplated by governmental authorities that would reasonably be expected to have a material impact on its financial position or results of **operations**[145](index=145&type=chunk) - No directors, officers, affiliates, or major stockholders are party to adverse material proceedings or have a material interest adverse to the **Company**[146](index=146&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) This section directs readers to the comprehensive 'Risk Factors' discussion in the company's Annual Report on Form 10-K for a detailed understanding of the risks associated with investing in its common stock - Investing in the **Company's common stock** involves a high degree of risk[147](index=147&type=chunk) - Readers should carefully consider the risks and uncertainties described in **Part I, Item 1A** of the **Annual Report on Form 10-K** for the year ended December 31, 2024[147](index=147&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports that there were no unregistered sales of equity securities or issuer purchases of equity securities during the period covered by this report - There were no unregistered sales of equity securities during the period[148](index=148&type=chunk) - There were no issuer purchases of equity securities during the period[149](index=149&type=chunk) [Item 3. Defaults Upon Senior Securities](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that the company has no defaults upon senior securities to report - There are no defaults upon senior securities[151](index=151&type=chunk) [Item 4. Mine Safety Disclosures](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - This item is not applicable to the **Company**[152](index=152&type=chunk) [Item 5. Other Information](index=27&type=section&id=Item%205.%20Other%20Information) This section provides an update on the pending merger with Cullgen, specifically noting that approval from the China Security Regulatory Commission (CSRC) is still outstanding, leading to an extension of the merger agreement term - Approval from the **China Security Regulatory Commission (CSRC)** to complete the **Merger** is still pending as of the filing date[153](index=153&type=chunk) - **Pulmatrix** and **Cullgen** mutually agreed to extend the term of the **Merger Agreement** by **60 days**, from **August 13, 2025**, to **October 12, 2025**[153](index=153&type=chunk) - There can be no assurance that **CSRC** approval will be received prior to the extended term end date[153](index=153&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section refers readers to the 'Index to Exhibits' for a complete list of documents filed or furnished as part of this Quarterly Report on Form 10-Q - See the 'Index to Exhibits' following the signature page for a list of exhibits filed or furnished with this **Quarterly Report on Form 10-Q**[154](index=154&type=chunk) [SIGNATURES](index=28&type=section&id=SIGNATURES) This section contains the official signatures, certifying the due authorization and filing of the report on behalf of Pulmatrix, Inc - The report was signed on **August 6, 2025**, by **Peter Ludlum**, **Interim Chief Executive Officer** and **Interim Chief Financial Officer**[158](index=158&type=chunk) [INDEX TO EXHIBITS](index=29&type=section&id=INDEX%20TO%20EXHIBITS) This section provides a detailed list of all exhibits accompanying the Form 10-Q, including amendments to the merger agreement and various certifications - The index lists exhibits such as **Amendment No. 1** to the **Agreement and Plan of Merger and Reorganization**, and certifications pursuant to the **Sarbanes-Oxley Act**[160](index=160&type=chunk)

[Corporate Update and Strategic Transactions](index=1&type=section&id=Corporate%20Update%20and%20Strategic%20Transactions) Pulmatrix is pursuing a merger with Cullgen and divesting its existing clinical assets and iSPERSE™ technology [Proposed Merger with Cullgen](index=1&type=section&id=Proposed%20Merger%20with%20Cullgen) Pulmatrix is progressing its merger with Cullgen, approved by stockholders and expected to close in 2025, forming an entity focused on targeted protein degradation - Pulmatrix entered into a merger agreement with Cullgen Inc. on November 13, 2024, to create a **Nasdaq-listed company** focused on **targeted protein degradation technology**[3](index=3&type=chunk)[4](index=4&type=chunk) - On June 16, 2025, Pulmatrix **stockholders approved the merger** and related proposals[6](index=6&type=chunk) - The merger is **expected to close in 2025**, but remains subject to customary closing conditions, including **approvals from Nasdaq and the China Security Regulatory Commission**[3](index=3&type=chunk)[6](index=6&type=chunk)[7](index=7&type=chunk) [Pulmatrix Currently Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology](index=2&type=section&id=Pulmatrix%20Currently%20Seeking%20Divestment%20of%20Clinical%20Assets%20and%20Proprietary%20iSPERSE%E2%84%A2%20Technology) Pulmatrix is divesting its iSPERSE™ technology and three clinical programs (PUR3100, PUR1800, PUR1900) in conjunction with the proposed merger - As part of the merger, Pulmatrix intends to **divest its proprietary iSPERSE™ technology and three related clinical programs**[2](index=2&type=chunk)[3](index=3&type=chunk) [iSPERSE™ Technology](index=2&type=section&id=iSPERSE%E2%84%A2%20Technology) iSPERSE™ is a proprietary technology for engineering small, dense, and dispersible dry powder particles for efficient drug delivery - iSPERSE™ is a **proprietary technology** for engineering small, dense, and dispersible dry powder particles for **efficient drug delivery to the lungs**[2](index=2&type=chunk)[12](index=12&type=chunk)[23](index=23&type=chunk) - As of June 30, 2025, the iSPERSE™ patent portfolio included approximately **146 granted patents** and **54 pending applications** worldwide[12](index=12&type=chunk) [PUR3100 (Acute Migraine)](index=2&type=section&id=PUR3100) PUR3100 is a Phase 2-ready inhaled DHE candidate for acute migraine, demonstrating rapid onset and lower nausea in Phase 1 - PUR3100 is a **Phase 2-ready**, orally inhaled dihydroergotamine (DHE) candidate for the treatment of acute migraine[12](index=12&type=chunk) - Phase 1 results demonstrated a **rapid time to maximum concentration (5 minutes)** and a **lower incidence of nausea** compared to intravenously administered DHE[12](index=12&type=chunk) [PUR1800 (AECOPD)](index=2&type=section&id=PUR1800) PUR1800, an iSPERSE™-developed NSKI for AECOPD, demonstrated safety and tolerability in a Phase 1b study - PUR1800 is a **Narrow Spectrum Kinase Inhibitor (NSKI)** developed with **iSPERSE™ technology** for treating acute exacerbations in chronic obstructive pulmonary disease (AECOPD)[10](index=10&type=chunk) - A Phase 1b study showed PUR1800 was **safe and well-tolerated**, supporting its continued development for AECOPD and other inflammatory respiratory diseases[10](index=10&type=chunk) [PUR1900 (Antifungal)](index=2&type=section&id=PUR1900) PUR1900, an inhaled iSPERSE™ itraconazole formulation, completed its U.S. Phase 2b wind-down, while a partner proceeds to Phase 3 in India - PUR1900 is an **inhaled iSPERSE™ formulation** of the antifungal drug itraconazole, with its U.S. Phase 2b study wind-down completed in **Q3 2024**[13](index=13&type=chunk) - Partner **Cipla** has completed a Phase 2 study in India and received approval to proceed with a Phase 3 trial, with Pulmatrix entitled to **2% royalties** on potential future net sales[13](index=13&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) This section details Pulmatrix's financial position and operational results, highlighting the impact of asset divestment and merger activities [Second Quarter 2025 Financial Results Summary](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Pulmatrix reported no Q2 2025 revenue, with reduced R&D and G&A expenses resulting in a $1.5 million net loss and $5.8 million cash, sufficient until merger closing Q2 2025 Financial Results | Financial Metric | Q2 2025 | Q2 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $1.6M | -$1.6M | Completion of PUR1900 Phase 2b trial wind-down | | R&D Expenses | <$0.1M | $2.8M | -$2.8M | Winding down PUR1900 trial and disposal of lab/facilities | | G&A Expenses | $1.5M | $2.0M | -$0.5M | Decreased employment and operating costs, offset by merger costs | | Net Loss | ($1.5M) | ($5.8M) | +$4.3M | Lower operating expenses | - The company's cash and cash equivalents balance was **$5.8 million** as of June 30, 2025, which is considered **sufficient to fund operations through the anticipated closing of the merger** with Cullgen[17](index=17&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) Consolidated financial statements show total assets decreased to $6.2 million by June 30, 2025, with no revenue and significantly reduced operating expenses [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) The balance sheets indicate a decrease in cash and total assets from December 31, 2024, to June 30, 2025, reflecting operational changes Consolidated Balance Sheets (in thousands) | Balance Sheet Item (in thousands) | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $5,825 | $9,521 | | Total current assets | $6,142 | $9,920 | | **Total assets** | **$6,152** | **$9,943** | | Total current liabilities | $548 | $929 | | **Total liabilities** | **$548** | **$996** | | **Total stockholders' equity** | **$5,604** | **$8,947** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Statements of operations show no revenue for Q2 and H1 2025, with reduced operating expenses leading to lower net losses compared to 2024 Consolidated Statements of Operations (Three Months Ended June 30, in thousands) | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $ - | $1,552 | | Total operating expenses | $1,548 | $7,453 | | Loss from operations | ($1,548) | ($5,901) | | **Net loss** | **($1,549)** | **($5,811)** | | **Net loss per share** | **($0.42)** | **($1.59)** | Consolidated Statements of Operations (Six Months Ended June 30, in thousands) | Statement of Operations (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $ - | $7,437 | | Total operating expenses | $3,395 | $12,591 | | Loss from operations | ($3,395) | ($5,154) | | **Net loss** | **($3,357)** | **($4,986)** | | **Net loss per share** | **($0.92)** | **($1.37)** | [Company Overview and Forward-Looking Statements](index=6&type=section&id=Company%20Overview%20and%20Forward-Looking%20Statements) This section provides an overview of Pulmatrix's historical focus on inhaled therapies and includes standard forward-looking statements regarding future risks [About Pulmatrix, Inc. & iSPERSE™ Technology](index=6&type=section&id=About%20Pulmatrix%2C%20Inc.%20%26%20iSPERSE%E2%84%A2%20Technology) Pulmatrix, a biopharmaceutical company, historically developed inhaled therapies for migraine and respiratory diseases using its iSPERSE™ dry powder delivery technology - Pulmatrix has focused on developing **inhaled therapeutic products for migraine and respiratory diseases** like COPD and ABPA[22](index=22&type=chunk) - The company's product candidates are based on its **proprietary iSPERSE™ engineered dry powder delivery platform**, which allows a broad range of drugs to be formulated for **highly efficient lung delivery**[22](index=22&type=chunk)[23](index=23&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements subject to risks, including the Cullgen merger, asset divestment, Nasdaq listing, and clinical trial outcomes - The document contains **forward-looking statements** that are not historical facts and are subject to **risks and uncertainties**[25](index=25&type=chunk) - Identified risks include, but are not limited to, the **Cullgen merger**, **divest assets**, **Nasdaq listing**, and **fund future operations**[25](index=25&type=chunk)

[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Unaudited Q1 2025 financial statements report a **$1.8 million net loss** from zero revenue, with a pending merger critical for future operations [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to **$8.1 million** from **$9.9 million** by Q1 2025, primarily due to reduced cash, impacting stockholders' equity Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,708 | $9,521 | | Total current assets | $8,041 | $9,920 | | Total assets | $8,051 | $9,943 | | Total current liabilities | $903 | $929 | | Total liabilities | $904 | $996 | | Total stockholders' equity | $7,147 | $8,947 | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2025 reported zero revenue and a **$1.8 million net loss**, a stark contrast to Q1 2024's **$5.9 million revenue** and **$0.8 million net income** Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenues | $0 | $5,885 | | Research and development | $19 | $3,512 | | General and administrative | $1,828 | $1,626 | | Total operating expenses | $1,847 | $5,138 | | (Loss) income from operations | ($1,847) | $747 | | Net (loss) income | ($1,808) | $825 | | Net (loss) income per share | ($0.50) | $0.23 | [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased from **$8.9 million** to **$7.1 million** in Q1 2025, primarily due to the **$1.8 million net loss** - Stockholders' equity decreased by **$1.8 million** in Q1 2025, from **$8,947 thousand** to **$7,147 thousand**, almost entirely due to the net loss of **$1,808 thousand**[17](index=17&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$1.8 million** in Q1 2025, an improvement from Q1 2024, with total cash ending at **$7.7 million** Cash Flow Summary (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,813) | ($2,719) | | Net cash used in investing activities | $0 | ($154) | | Net decrease in cash, cash equivalents and restricted cash | ($1,813) | ($2,873) | | Cash, cash equivalents and restricted cash — end of period | $7,718 | $17,772 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the critical pending merger with Cullgen Inc., whose failure could lead to dissolution, and current cash sufficiency is contingent on the merger's outcome - Pulmatrix entered a Merger Agreement with Cullgen Inc. on November 13, 2024, with pre-merger Cullgen stockholders owning approximately **96.4%** and Pulmatrix stockholders **3.6%** of the combined company post-merger[24](index=24&type=chunk)[28](index=28&type=chunk) - The company's future operations are highly dependent on the successful consummation of the merger; failure could lead to board-initiated dissolution and liquidation[33](index=33&type=chunk)[36](index=36&type=chunk) - The fair value of the warrant liability was remeasured at **$1 thousand** as of March 31, 2025, resulting in a gain of **$66 thousand** for the quarter[52](index=52&type=chunk) - On April 7, 2025, the Merger Agreement was amended to revise the transaction structure from a two-step merger to a one-step merger[66](index=66&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift post-Cullgen merger agreement, pausing clinical asset development for monetization, with Q1 2025 showing a net loss and liquidity contingent on merger success [Overview](index=16&type=section&id=Overview) Pulmatrix entered a merger agreement with Cullgen Inc., pausing product development to monetize assets, with its future highly dependent on the merger's success - The company entered into a Merger Agreement with Cullgen Inc. on November 13, 2024, which was unanimously approved by the board[75](index=75&type=chunk) - In connection with the merger, the company is exploring opportunities to monetize its clinical assets (PUR3100, PUR1800, PUR1900) and has paused their development[81](index=81&type=chunk) - The company's future operations are highly dependent on the success of the Merger; if not consummated, the board may pursue dissolution and liquidation[78](index=78&type=chunk) [Therapeutic Candidates](index=19&type=section&id=Therapeutic%20Candidates) Details therapeutic candidates PUR3100, PUR1800, and PUR1900, all being explored for monetization, with PUR1900 having a **2% royalty** agreement with Cipla - PUR3100 (inhaled DHE for migraine) is Phase 2-ready, with its IND application accepted by the FDA in September 2023, and the company is seeking financing or partnership for Phase 2[87](index=87&type=chunk)[94](index=94&type=chunk) - PUR1800 (for AECOPD) completed a Phase 1b study with positive safety and tolerability, supporting continued development, and the company is exploring monetization opportunities for this asset[98](index=98&type=chunk)[99](index=99&type=chunk)[101](index=101&type=chunk) - For PUR1900, partner Cipla holds exclusive development and commercialization rights outside the U.S., paying Pulmatrix a **2% royalty** on future net sales, while Pulmatrix seeks to monetize the asset within the United States[103](index=103&type=chunk)[105](index=105&type=chunk)[108](index=108&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q1 2025 revenues fell by **$5.9 million** to zero, R&D expenses decreased by **$3.5 million**, and G&A expenses increased by **$0.2 million** due to merger costs Comparison of Results of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $0 | $5,885 | ($5,885) | | Research and development | $19 | $3,512 | ($3,493) | | General and administrative | $1,828 | $1,626 | $202 | | Net (loss) income | ($1,808) | $825 | ($2,633) | - The **$5.9 million** decrease in revenue is primarily related to the completion of the wind-down of the PUR1900 Phase 2b clinical trial during 2024[117](index=117&type=chunk) - The **$3.5 million** decrease in R&D expenses was mainly due to **$2.2 million** less in employment/operating costs after the MannKind Transaction and **$1.2 million** less in costs for the PUR1900 program[118](index=118&type=chunk) - The **$0.2 million** increase in G&A expenses was primarily due to **$0.7 million** of costs related to the Merger, partially offset by decreased employment and other operating costs[119](index=119&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, Pulmatrix had **$7.7 million** in cash, with an accumulated deficit of **$299.0 million**, and management believes current cash is sufficient for 12 months - The company had a cash and cash equivalents balance of **$7.7 million** as of March 31, 2025[120](index=120&type=chunk) - Management expects existing cash and cash equivalents will be sufficient to fund corporate operating expenses for at least the next 12 months[122](index=122&type=chunk) Cash Flow Summary (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,813) | ($2,719) | | Net cash used in investing activities | $0 | ($154) | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is marked as 'Not applicable,' indicating no material exposure to market risks requiring quantitative and qualitative disclosure - The company states this item is not applicable[132](index=132&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[133](index=133&type=chunk) - There were no material changes in internal control over financial reporting during Q1 2025[135](index=135&type=chunk) [PART II—OTHER INFORMATION](index=26&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not aware of any material legal proceedings against it, its subsidiaries, or its property - As of the filing date, the company is not aware of any material legal proceedings to which it is a party[137](index=137&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) Investors are directed to the Annual Report on Form 10-K for December 31, 2024, for a comprehensive understanding of the company's risk factors - Investors are advised to consider the risks and uncertainties described in the company's Annual Report on Form 10-K for the year ended December 31, 2024[139](index=139&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or issuer purchases of its equity securities during the reporting period - The company reports no unregistered sales of equity securities or issuer purchases of its equity securities for the period[140](index=140&type=chunk)[141](index=141&type=chunk) [Item 3. Defaults Upon Senior Securities](index=26&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities during the period - None reported[143](index=143&type=chunk) [Item 4. Mine Safety Disclosures](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is marked as 'Not applicable' - Not applicable[145](index=145&type=chunk) [Item 5. Other Information](index=26&type=section&id=Item%205.%20Other%20Information) The company reports no other information for disclosure in this item - None reported[146](index=146&type=chunk) [Item 6. Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section provides a list of exhibits filed or furnished with this Quarterly Report on Form 10-Q - Refers to the 'Index to Exhibits' for a list of exhibits filed or furnished with the report[147](index=147&type=chunk)

Core Viewpoint - Pulmatrix, Inc. is advancing its proposed merger with Cullgen, which is expected to close in June 2025, while divesting its clinical assets including the acute migraine candidate PUR3100 and its proprietary iSPERSE™ technology [1][3][2] Financial Performance - For the first quarter of 2025, Pulmatrix reported revenues of $0, a decrease of approximately $5.9 million compared to $5.9 million in the same period of 2024, primarily due to the completion of the PUR1900 Phase 2b clinical trial [11] - Research and development expenses decreased to less than $0.1 million, down approximately $3.5 million from $3.5 million in the first quarter of 2024, attributed to winding down the PUR1900 trial and other operational changes [12] - General and administrative expenses increased to $1.8 million, up approximately $0.2 million from $1.6 million in the first quarter of 2024, mainly due to costs related to the proposed merger [13] - As of March 31, 2025, the company's total cash and cash equivalents were $7.7 million, which is expected to be sufficient to fund operations through the anticipated merger closing [14] Product Pipeline and Technology - Pulmatrix's product pipeline includes PUR3100, an inhaled dihydroergotamine for acute migraine, which is Phase 2-ready following FDA acceptance of its IND application [7] - The company is also developing PUR1800, a Narrow Spectrum Kinase Inhibitor for chronic obstructive pulmonary disease, which has shown safety and tolerability in Phase 1b studies [6] - The iSPERSE™ technology enables the formulation of drugs into small, dense, and dispersible particles for efficient delivery to the lungs, enhancing therapeutic outcomes for various diseases [21][20] Merger Details - The merger agreement with Cullgen was initially reported on November 13, 2024, and amended on April 7, 2025, with the closing anticipated in June 2025, subject to certain conditions [3][4] - If successful, the merger will create a Nasdaq-listed company focused on targeted protein degradation technology, with three degrader programs in Phase 1 clinical trials [2]

Product Development - The company is focused on developing novel inhaled therapeutic products for migraine and respiratory diseases using its patented iSPERSE technology[313]. - The current product pipeline includes PUR3100 for acute migraine, PUR1800 for acute exacerbations of COPD, and PUR1900 for ABPA in asthma and cystic fibrosis patients[320]. - PUR3100 has received FDA acceptance for its IND application and is positioned for a Phase 2 clinical study, with a study may proceed letter received in September 2023[333]. - The Phase 1 study of PUR3100 demonstrated a lower incidence of nausea (21% vs. 86%) and vomiting (0% vs. 29%) compared to IV DHE, indicating improved tolerability[336]. - The company is exploring monetization opportunities for PUR1800, which targets p38 MAP kinases and is being developed for AECOPD treatment[338]. - PUR1800 has completed a Phase 1b study showing it was well tolerated with no safety signals, supporting its continued development for AECOPD[341]. - The company is committed to expanding its intellectual property portfolio and seeking partnerships to support product development and commercialization[327]. Financial Performance - Revenues for the year ended December 31, 2024, were $7.8 million, an increase of $0.5 million from $7.3 million in 2023, primarily due to a contract modification of the Cipla Agreement[359]. - Research and development expenses decreased to $7.2 million in 2024 from $15.5 million in 2023, a reduction of approximately $8.4 million, mainly due to decreased spending on the PUR1900 program[360]. - General and administrative expenses increased to $7.8 million in 2024 from $6.5 million in 2023, an increase of approximately $1.3 million, driven by higher legal and professional service costs[361]. - The loss on the MannKind Transaction was $2.6 million in 2024, compared to no such loss in 2023, related to the assignment of the long-term lease of the Bedford facility[362]. - The accumulated deficit as of December 31, 2024, was $297.2 million, primarily due to research and development and general administrative expenses[363]. - Cash and cash equivalents as of December 31, 2024, totaled $9.5 million, expected to fund operating expenses for at least the next 12 months[365]. - Net cash used in operating activities for 2024 was $10.7 million, compared to $16.0 million in 2023, reflecting a decrease in cash outflows[368][369]. - The company will receive 2% royalties on any potential future net sales by Cipla outside the United States[348]. - The company completed all Phase 2b wind down activities in the third quarter of 2024, eliminating further financial responsibility for commercialization in the Cipla Territory[348]. - The company anticipates needing additional capital to fund operations and continue development of its iSPERSE pipeline programs[364]. Capital and Financing - The company entered into a Merger Agreement with Cullgen Inc. on November 13, 2024, subject to stockholder approvals and other customary conditions[316]. - The Merger aims to combine the businesses of Pulmatrix and Cullgen, with the potential to enhance the combined company's capabilities and market position[317]. - No net cash was provided by financing activities for the year ended December 31, 2024; however, in 2023, net cash provided resulted from proceeds from the issuance of common stock under the Sales Agreement[371]. - The Company entered into an At-The-Market Sales Agreement to issue and sell up to $20.0 million of common stock, but the actual amount that can be raised is limited until the public float exceeds $75,000,000[373]. - During the year ended December 31, 2023, the Company sold 13,100 shares of common stock at a weighted-average price of approximately $4.25 per share, resulting in net proceeds of approximately $53 thousand[375]. Industry Risks - The Company faces risks and uncertainties common to the biopharmaceutical industry, including the need for significant additional capital for product development and regulatory approvals[376].

Financial Performance - Revenues increased approximately $0.5 million to $7.8 million for the year ended December 31, 2024, compared to $7.3 million for the year ended December 31, 2023[9]. - Research and development expenses decreased approximately $8.4 million to $7.2 million for the year ended December 31, 2024, compared to $15.5 million for the year ended December 31, 2023[10]. - General and administrative expenses increased approximately $1.3 million to $7.8 million for the year ended December 31, 2024, compared to $6.5 million for the year ended December 31, 2023[11]. - The Company recognized a $2.6 million loss on its transactions with MannKind Corporation during the third quarter of 2024[12]. Cash Position - Total cash and cash equivalents balance as of December 31, 2024, was $9.5 million, sufficient to fund operations at least through the anticipated closing of the Merger with Cullgen[13]. Merger and Acquisition - The proposed merger with Cullgen is anticipated to close in the first half of 2025, subject to certain closing conditions[3]. - Pulmatrix intends to divest its assets, including its Phase 2-ready acute migraine candidate, PUR3100, as part of the proposed merger[1]. Product Development - PUR3100 is positioned as Phase 2-ready, with the FDA accepting an IND application and a Phase 2 clinical protocol planned[5]. - The Phase 1 trial results of PUR3100 showed lower incidence of nausea and no vomiting compared to IV-administered DHE[5]. Intellectual Property - As of December 31, 2024, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 149 granted patents and 50 pending patent applications[14].

Core Viewpoint - Pulmatrix, Inc. has announced a proposed merger with Cullgen, expected to close in the first half of 2025, while planning to divest its clinical assets including its acute migraine candidate, PUR3100, and other development candidates based on its iSPERSE™ technology [1][2][3] Merger Details - The merger agreement with Cullgen was announced on November 13, 2024, and is subject to certain closing conditions [3][4] - If successful, the merger will create a Nasdaq-listed company focused on targeted protein degradation technology, with three degrader programs entering or about to initiate Phase 1 clinical trials [2][3] Financial Performance - For the year ended December 31, 2024, Pulmatrix reported revenues of approximately $7.8 million, an increase from $7.3 million in 2023, primarily due to a contract modification with Cipla [8] - Research and development expenses decreased to $7.2 million in 2024 from $15.5 million in 2023, attributed to winding down the PUR1900 Phase 2b clinical trial and other cost reductions [9] - General and administrative expenses rose to $7.8 million in 2024 from $6.5 million in 2023, mainly due to legal and professional service costs [10] - The company recognized a $2.6 million loss related to transactions with MannKind Corporation [11] - As of December 31, 2024, Pulmatrix had total cash and cash equivalents of $9.5 million, which is expected to fund operations through the anticipated merger closing [12] Product Pipeline - PUR3100 is a Phase 2-ready acute migraine candidate that has received FDA acceptance for an Investigational New Drug application and is set to proceed with a Phase 2 study [6][14] - PUR1800, a Narrow Spectrum Kinase Inhibitor for treating acute exacerbations in chronic obstructive pulmonary disease, has shown safety and tolerability in Phase 1b studies [6] - The iSPERSE™ technology is designed to enhance drug delivery for various therapeutic applications, with a patent portfolio that includes approximately 149 granted patents [14][18] Summary of Financial Statements - The net loss for the year ended December 31, 2024, was $9.6 million, compared to a net loss of $14.1 million in 2023, with a loss per share of $(2.62) [16][17] - Total operating expenses decreased to $17.6 million in 2024 from $22.0 million in 2023 [16]

Group 1 - Halper Sadeh LLC is investigating Pulmatrix, Inc. and Entero Therapeutics, Inc. for potential violations of federal securities laws and breaches of fiduciary duties to shareholders related to their respective mergers [1][2] - In the proposed merger between Pulmatrix, Inc. and Cullgen Inc., Pulmatrix stockholders are expected to own approximately 3.6% of the combined company upon closing [1] - In the merger between Entero Therapeutics, Inc. and Journey Therapeutics, Inc., Journey shareholders will acquire 99% of the equity of Entero upon closing [2] Group 2 - Halper Sadeh LLC may seek increased consideration for shareholders, additional disclosures, and other relief and benefits on behalf of shareholders [3] - Shareholders are encouraged to contact Halper Sadeh LLC free of charge to discuss their legal rights and options [4] - Halper Sadeh LLC represents investors globally who have been victims of securities fraud and corporate misconduct, recovering millions on behalf of defrauded investors [4]

Core Points - A merger agreement has been announced between Pulmatrix, Inc. and Cullgen Inc. to create a Nasdaq-listed company focused on targeted protein degradation technology, with three degrader programs entering or about to initiate Phase 1 clinical trials, two for cancer treatment and one for pain management [1][3] - The combined company is expected to have approximately $65 million in cash and cash equivalents at the close of the merger, providing funding through multiple clinical milestones and a runway expected to last through 2026 [1] - As part of the merger, Pulmatrix plans to divest its assets, including its acute migraine candidate, PUR3100, and other development candidates based on its iSPERSE™ technology [1][6] Proposed Transaction Details - Upon closing, pre-merger Pulmatrix stockholders are expected to own approximately 3.6% of the combined company, while pre-merger Cullgen stockholders will own approximately 96.4% [3] - The transaction is anticipated to close by the end of March 2025, pending stockholder and regulatory approvals [4] - The executive leadership of the combined company will be led by Cullgen's Chairman and CEO, Ying Luo, Ph.D., with one representative from Pulmatrix joining the board [5] Clinical Pipeline Overview - Cullgen has three degrader programs in or about to initiate Phase 1 clinical testing, including CG001419, a first-in-class oral pan-TRK degrader for solid tumors and pain management [7] - CG009301, a GSPT1 degrader, is being evaluated for blood cancers and has received IND allowance from the China CDE, with patient dosing expected in Q1 2025 [8] - Additional targeted protein degraders and degrader-antibody conjugates (DACs) are being developed, primarily for cancer and autoimmune diseases, including a partnered program with Astellas Pharma Inc. [9]

Core Insights - Pulmatrix, Inc. is focusing on leveraging its iSPERSE™ technology and optimizing the potential of its clinical assets, particularly PUR3100, while pursuing strategic alternatives [1][2] - The company has completed the wind down of the PUR1900 program and has closed transactions with MannKind Corporation, validating the potential value of its technology [1][2] Financial Performance - For Q3 2024, Pulmatrix reported revenues of $0.4 million, a decrease of approximately $1.4 million from $1.8 million in Q3 2023, primarily due to reduced revenue from the Cipla Agreement related to the PUR1900 wind down [7] - Research and development expenses decreased to $0.8 million in Q3 2024 from $4.0 million in Q3 2023, attributed to cost savings following the MannKind transaction and the completion of the PUR1900 program [8] - General and administrative expenses increased to $2.2 million in Q3 2024 from $1.7 million in Q3 2023, mainly due to one-time employee separation costs [9] - As of September 30, 2024, the company had cash and cash equivalents of $10.8 million, projected to fund operations into Q4 2026 [10] Clinical Development Updates - PUR3100, an inhaled dihydroergotamine for acute migraine, is Phase 2-ready following FDA acceptance of its IND application, with plans for a Phase 2 clinical study [3] - The Phase 1 trial results for PUR3100 indicated that it achieved peak exposures in the therapeutic range with a lower incidence of nausea compared to IV-administered DHE [3] - PUR1800, a Narrow Spectrum Kinase Inhibitor for acute exacerbations in COPD, has shown safety and tolerability in Phase 1b studies, and the company plans to pursue partnerships for its advancement [4] Strategic Partnerships and Licensing - The company has entered into a cross-license agreement with MannKind, granting exclusive licenses for various iSPERSE formulations, including those for insulin and treatments for nontuberculous mycobacteria lung disease [6] - Pulmatrix will receive 2% royalties on potential future net sales of PUR1900 by Cipla outside the U.S., while both companies will seek to monetize the product within the U.S. [5] Patent Portfolio - As of September 30, 2024, Pulmatrix holds approximately 147 granted patents related to iSPERSE™, with 18 granted U.S. patents and 51 pending applications [7]