Pulmatrix(PULM) - 2025 Q3 - Quarterly Results

Corporate Overview and Strategic Initiatives This section outlines Pulmatrix's Q3 2025 updates, the proposed Cullgen merger, and the iSPERSE™ divestment Third Quarter 2025 Highlights & Corporate Update Pulmatrix announced its third quarter 2025 financial results and a strategic plan to divest its migraine and inhalation assets, including the iSPERSE™ technology, as it focuses on completing a proposed merger with Cullgen - Pulmatrix announced third quarter 2025 financial results and a plan to divest its proprietary dry powder delivery technology, iSPERSE™, and related assets[1] - The company's focus in Q3 2025 was to advance steps to complete the proposed merger with Cullgen, a clinical-stage biopharmaceutical company focused on targeted protein degrader therapies[2] - If consummated, the merger would create a Nasdaq-listed company focused on targeted protein degradation technology with three degrader programs in Phase 1 clinical trials[2] Proposed Merger with Cullgen Pulmatrix entered into a merger agreement with Cullgen Inc. on November 13, 2024, which was approved by Pulmatrix stockholders on June 16, 2025. The closing is subject to customary conditions, including Nasdaq and China Security Regulatory Commission approvals, and will result in Cullgen's business continuing as the combined company - Pulmatrix entered into a merger agreement with Cullgen Inc. on November 13, 2024, amended on April 7, 2025[3] - Pulmatrix stockholders approved the Merger and related proposals on June 16, 2025[5] - The closing of the merger is subject to customary conditions, including Nasdaq listing approval and approval from the China Security Regulatory Commission[5] - If the merger is completed, Cullgen's business will continue as the business of the combined company[6] Divestment Plan for iSPERSE™ Technology and Clinical Assets As part of the proposed merger, Pulmatrix is actively seeking to divest its patent portfolio encompassing the iSPERSE™ technology and three related clinical programs, including its Phase 2-ready acute migraine program - Pulmatrix is in the process of potentially divesting its patent portfolio for iSPERSE™ technology and three related clinical programs, including its Phase 2-ready acute migraine program[2] - The company is currently seeking divestment of its clinical assets and proprietary iSPERSE™ technology[7] iSPERSE™ Technology and Clinical Pipeline This section details Pulmatrix's proprietary iSPERSE™ dry powder delivery technology and its clinical pipeline iSPERSE™ Technology Overview iSPERSE™ is Pulmatrix's proprietary dry powder delivery technology, engineered for superior drug delivery to the lungs with small, dense, and dispersible particles, aiming to improve pharmacokinetics and reduce systemic side effects. The technology is protected by a substantial patent portfolio - iSPERSE™ particles are engineered for superior drug delivery to the lungs, exceeding traditional dry powder performance with dispersibility advantages[10] - As of September 30, 2025, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 146 granted patents (18 U.S.) and 50 pending patent applications[10] - iSPERSE™ is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs[20] Clinical Asset Details Pulmatrix's clinical pipeline includes PUR3100 for acute migraine (Phase 2-ready), PUR1800 for AECOPD (Phase 1b completed), and PUR1900 for antifungal indications, which is in Phase 3 development in India through a partnership with Cipla PUR3100 (Acute Migraine) PUR3100, an orally inhaled DHE using iSPERSE™ technology, is a Phase 2-ready asset for acute migraine. Phase 1 results showed peak exposures in the targeted therapeutic range, rapid time to maximum concentration, and a lower incidence of nausea compared to IV DHE - PUR3100 is an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™ technology for acute migraine, and is a Phase 2-ready asset with FDA IND acceptance[10] - Phase 1 trial results for PUR3100 showed peak exposures in the targeted therapeutic range, time to maximum concentration at five minutes, and a lower incidence of nausea with no vomiting compared to IV DHE[10] PUR1800 (AECOPD) PUR1800, a Narrow Spectrum Kinase Inhibitor (NSKI) utilizing iSPERSE™ technology, is being developed for acute exacerbations in chronic obstructive pulmonary disease (AECOPD). A Phase 1b study in 2023 indicated PUR1800 was well-tolerated with no observed safety signals, supporting its continued development - PUR1800 is a Narrow Spectrum Kinase Inhibitor (NSKI) engineered with iSPERSE™ technology for the treatment of acute exacerbations in chronic obstructive pulmonary disease (AECOPD)[10] - Complete results from a Phase 1b study in 2023 indicated PUR1800 was well-tolerated with no observed safety signals, supporting its continued development[10] PUR1900 (Antifungal) PUR1900 is an inhaled iSPERSE™ formulation of itraconazole. While Pulmatrix wound down its Phase 2b trial in 2024, its partner Cipla has completed a Phase 2 study in India and received approval to proceed with a Phase 3 clinical trial, with Pulmatrix eligible for 2% royalties on future net sales outside the United States - PUR1900 is an inhaled iSPERSE™ formulation of the antifungal drug itraconazole[10] - Cipla, Pulmatrix's partner, completed its Phase 2 study in India in 2025 and received approval to proceed with a Phase 3 clinical trial[10] - Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States[10] Third Quarter 2025 Financial Performance This section summarizes Pulmatrix's Q3 2025 financial results, including balance sheets and statements of operations Overview of Financial Performance Pulmatrix reported a significant decrease in revenues, R&D expenses, and G&A expenses for Q3 2025 compared to Q3 2024, primarily due to the wind-down of the PUR1900 Phase 2b clinical trial and operational efficiencies. The company maintains a cash position sufficient to fund operations into Q4 2026 | Metric | Q3 2025 (in thousands) | Q3 2024 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------- | :--------------------- | :--------------------- | :-------------------- | :--------- | | Revenues | $0 | $366 | $(366) | -100% | | Research and development | $8 | $814 | $(806) | -99.0% | | General and administrative | $858 | $2,209 | $(1,351) | -61.2% | - The decrease in revenues, R&D, and G&A expenses was primarily related to the completion of the PUR1900 Phase 2b clinical trial wind-down, disposal of lab/facilities lease, and employee terminations[11][12][13] | Metric | September 30, 2025 (in millions) | | :---------------------- | :------------------------------- | | Cash and cash equivalents | $4.8 | - The company anticipates its cash position is sufficient to fund operations into the fourth quarter of 2026[14] Consolidated Balance Sheets As of September 30, 2025, Pulmatrix reported a decrease in cash and cash equivalents, total current assets, and total assets compared to December 31, 2024. Total liabilities also decreased significantly, leading to a reduction in total stockholders' equity | Metric (in thousands) | Sep 30, 2025 | Dec 31, 2024 | | :---------------------------- | :----------- | :----------- | | Cash and cash equivalents | $4,794 | $9,521 | | Total current assets | $4,972 | $9,920 | | Total assets | $4,982 | $9,943 | | Total current liabilities | $249 | $929 | | Total liabilities | $249 | $996 | | Total stockholders' equity | $4,733 | $8,947 | Consolidated Statements of Operations For the three months ended September 30, 2025, Pulmatrix reported no revenues, a net loss of $0.877 million, and a net loss per share of $0.24. This represents a significant reduction in net loss compared to the same period in 2024, driven by decreased operating expenses | Metric (in thousands) | Three Months Ended Sep 30, 2025 | Three Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2025 | Nine Months Ended Sep 30, 2024 | | :-------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Revenues | $ - | $ 366 | $ - | $ 7,803 | | Research and development | $ 8 | $ 814 | $ 41 | $ 7,160 | | General and administrative | $ 858 | $ 2,209 | $ 4,220 | $ 5,836 | | Loss from operations | $ (866) | $ (2,657) | $ (4,261) | $ (7,811) | | Net loss | $ (877) | $ (2,587) | $ (4,234) | $ (7,573) | | Net loss per share (basic and diluted) | $ (0.24) | $ (0.71) | $ (1.16) | $ (2.07) | Additional Company Information This section provides company background, a forward-looking statements disclaimer, and investor contact information About Pulmatrix, Inc. Pulmatrix is a biopharmaceutical company focused on developing novel inhaled therapeutic products for migraine and respiratory diseases using its patented iSPERSE™ technology, which aims to improve drug delivery and patient outcomes - Pulmatrix is a biopharmaceutical company focused on developing novel inhaled therapeutic products for migraine and respiratory diseases using its patented iSPERSE™ technology[19] - The company's proprietary product pipeline includes treatments for CNS disorders (e.g., acute migraine) and serious lung diseases (e.g., COPD, ABPA)[19] - iSPERSE™ is an engineered dry powder delivery platform designed to improve therapeutic delivery to the lungs by optimizing pharmacokinetics and reducing systemic side effects[19] Forward-Looking Statements This section provides a disclaimer regarding forward-looking statements, highlighting that actual results may differ materially due to various factors, including the consummation of the Cullgen merger, the ability to divest assets, clinical trial delays, regulatory approvals, funding, and patent protection - Forward-looking statements are subject to risks and uncertainties, and actual results could differ materially[22] - Key factors include the consummation and timing of the proposed merger with Cullgen, the ability to divest clinical assets, maintaining Nasdaq listing, raising capital, delays in clinical trials, and obtaining regulatory approvals[22] - The company disclaims any intention or obligation to revise forward-looking statements, except as required by law[22] Investor Contact Contact information for investor relations is provided for inquiries - Investor contact information is provided for Chuck Padala of LifeSci Advisors[23]