Pulmatrix(PULM) - 2025 Q2 - Quarterly Results

Corporate Update and Strategic Transactions Pulmatrix is pursuing a merger with Cullgen and divesting its existing clinical assets and iSPERSE™ technology Proposed Merger with Cullgen 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][4] - On June 16, 2025, Pulmatrix stockholders approved the merger and related proposals[6] - 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][6][7] Pulmatrix Currently Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology 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][3] iSPERSE™ Technology 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][12][23] - As of June 30, 2025, the iSPERSE™ patent portfolio included approximately 146 granted patents and 54 pending applications worldwide[12] PUR3100 (Acute Migraine) 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] - Phase 1 results demonstrated a rapid time to maximum concentration (5 minutes) and a lower incidence of nausea compared to intravenously administered DHE[12] PUR1800 (AECOPD) 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] - A Phase 1b study showed PUR1800 was safe and well-tolerated, supporting its continued development for AECOPD and other inflammatory respiratory diseases[10] PUR1900 (Antifungal) 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] - 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] Financial Performance 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 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] Consolidated Financial Statements 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 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 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 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 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] - 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][23] Forward-Looking Statements 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] - Identified risks include, but are not limited to, the Cullgen merger, divest assets, Nasdaq listing, and fund future operations[25]