UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q For the transition period from ___________ to __________ Commission file number: 001-36199 PULMATRIX, INC. (Exact name of registrant as specified in its charter) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or Delaware 46-1821392 (State or other jurisdiction of incorporation or organization) ☐ TRANSITION REPORT PURSUANT TO SEC ...

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 - Monteverde & Associates PC is investigating Pulmatrix, Inc. regarding its proposed merger with Cullgen, Inc., where Pulmatrix stockholders are expected to own approximately 3.6% of the combined company [1] - Monteverde & Associates PC has a successful track record in recovering millions of dollars for shareholders and is recognized as a Top 50 Firm by ISS Securities Class Action Services Report [1] - The firm operates from the Empire State Building in New York City and specializes in class action securities litigation [2][4] Group 2 - The firm encourages shareholders with concerns about the merger to contact them for additional information free of charge [3] - Monteverde & Associates PC emphasizes that no company, director, or officer is above the law, reinforcing their commitment to shareholder rights [3]

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]

Product Development and Pipeline - The company is focused on developing novel inhaled therapeutic products using its patented iSPERSE technology, targeting respiratory and CNS disorders [77]. - The current product pipeline includes PUR3100 for acute migraine, PUR1800 for AECOPD, and PUR1900 for ABPA, with each candidate designed to achieve specific therapeutic objectives [80]. - PUR3100 has received FDA acceptance for its IND application and is positioned for a Phase 2 clinical study, with a focus on safety and preliminary efficacy in acute migraine patients [86]. - The Phase 1 study of PUR3100 indicated it was safe and well-tolerated, with a Tmax of 5 minutes and Cmax within the targeted therapeutic range for all doses tested [85]. - PUR3100 demonstrated improved tolerability with lower incidence of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%) compared to IV DHE [104]. - The PK profile of PUR3100 showed a lower AUC0–2h (1120–4320 vs. 6340) and a lower Cmax (3620–14,400 vs. 45,000) while maintaining efficacy levels above 1000 pg/mL [104]. - The anticipated benefits of RV1162 include effective anti-inflammatory outcomes in corticosteroid-resistant patients, addressing approximately 80% of AECOPD exacerbations caused by infections [106]. - The company has entered into a License, Development and Commercialization Agreement with RespiVert for the development of RV1162, which is now formulated as PUR1800 [109]. - The company intends to leverage its iSPERSE technology to identify new product candidates for diseases with significant unmet medical needs [81]. Financial Performance - Revenues were $0.4 million for the three months ended September 30, 2024, down from $1.8 million in the same period in 2023, a decrease of $1.4 million [130]. - Revenues for the nine months ended September 30, 2024, were $7.8 million, an increase of $2.7 million from $5.1 million in the same period of 2023, primarily due to a contract modification of the Cipla Agreement [134]. - Research and development expenses decreased to $0.8 million for the three months ended September 30, 2024, from $4.0 million in the same period in 2023, a reduction of approximately 80% [131]. - Research and development expenses decreased to $7.2 million for the nine months ended September 30, 2024, down approximately $4.8 million from $12.0 million in the same period of 2023, mainly due to reduced costs associated with the PUR1900 program and the MannKind Transaction [135]. - General and administrative expenses increased to $2.2 million for the three months ended September 30, 2024, compared to $1.7 million in the same period in 2023, an increase of approximately 29% [132]. - General and administrative expenses increased slightly to $5.8 million for the nine months ended September 30, 2024, compared to $5.6 million in the same period in 2023, primarily due to increased employment costs [136]. - The company incurred a loss of $2.6 million on the MannKind Transaction for certain assets held for sale during the three months ended September 30, 2024, with no such loss reported in the previous year [137]. - As of September 30, 2024, the company had an accumulated deficit of $295.2 million and total cash and cash equivalents of $10.8 million [138]. - Net cash used in operating activities was $9.5 million for the nine months ended September 30, 2024, a decrease from $14.0 million in the same period of 2023 [142][143]. - No cash was provided by financing activities for the nine months ended September 30, 2024, while $53,000 was provided in the same period of 2023 [145]. Strategic Plans and Partnerships - The company plans to continue incurring substantial expenses and operating losses for several years as it advances its drug development plans [83]. - The company aims to seek partnerships and license agreements to support the development and commercialization of its product candidates [92]. - The company completed all Phase 2b wind down activities for PUR1900 within the third quarter of 2024, transferring commercialization responsibilities to Cipla [120]. - The company expects to utilize external resources for further development following the termination of the majority of its research and development employees after the MannKind Transaction [123]. - The company anticipates continued losses due to development costs associated with its iSPERSE pipeline programs and is exploring financing or partnership arrangements for further development [139]. - The existing cash and cash equivalents are expected to fund corporate operating expenses for at least the next 12 months, although projections may be subject to change [140]. - The company has no material off-balance sheet arrangements that could significantly affect its financial condition [141]. Market Context - There are over 39 million migraine patients in the U.S., with no orally inhaled DHE treatment options currently available [105].