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]

Financial Performance - Revenues decreased approximately $1.4 million to $0.4 million for Q3 2024, compared to $1.8 million for Q3 2023, primarily due to reduced revenue under the Cipla Agreement related to the wind down of the PUR1900 Phase 2b clinical trial[6]. - The net loss for Q3 2024 was approximately $2.6 million, compared to a net loss of $3.8 million for Q3 2023[12]. Research and Development - Research and development expenses decreased approximately $3.2 million to $0.8 million for Q3 2024, compared to $4.0 million for Q3 2023, mainly due to reduced employment and operating costs following the MannKind cross-license agreement[7]. - The Phase 1 trial results for PUR3100 indicated that it achieved peak exposures in the targeted therapeutic range, with time to maximum concentration occurring at five minutes after dosing[2]. - Pulmatrix is exploring financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100, which is positioned as Phase 2-ready following FDA acceptance of its IND application[2]. - The company plans to pursue partnership or other alternatives to monetize or advance PUR1800, which is a Narrow Spectrum Kinase Inhibitor for the treatment of acute exacerbations in chronic obstructive pulmonary disease[3]. Expenses - General and administrative expenses increased approximately $0.5 million to $2.2 million for Q3 2024, compared to $1.7 million for Q3 2023, primarily due to one-time employee separation costs[8]. Cash Position - The total cash and cash equivalents balance as of September 30, 2024, was $10.8 million, with a projected cash runway into Q4 2026[9]. Intellectual Property - As of September 30, 2024, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 147 granted patents and 51 pending patent applications[5]. Clinical Trials - Pulmatrix completed all wind down activities for the PUR1900 Phase 2b study in Q3 2024, and will receive 2% royalties on any potential future net sales by Cipla outside the United States[4].

Company Overview - The company is a clinical-stage biopharmaceutical firm focused on developing novel inhaled therapeutic products using its patented iSPERSE technology, targeting respiratory and CNS disorders [69]. - The company aims to seek partnerships and license agreements to support the development and commercialization of its product candidates [82]. - The company is leveraging its iSPERSE technology to identify new product candidates for diseases with significant unmet medical needs [80]. Product Pipeline - 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 [71]. - PUR3100 has received FDA acceptance for its IND application and is positioned for a Phase 2 clinical study, which will evaluate its safety and efficacy in treating acute migraine [76]. - PUR1800 has completed a Phase 1b clinical study, showing safety and tolerability, and is being developed for the treatment of AECOPD [77]. - The company has terminated the PUR1900 Phase 2b study but will seek to monetize it in the U.S., while receiving 2% royalties on future net sales by Cipla outside the U.S. [78]. Financial Performance - Revenues for the three months ended June 30, 2024, were $1.6 million, a decrease of $0.3 million from $1.8 million in the same period of 2023, primarily due to the winding down of the PUR1900 Phase 2b clinical trial [105]. - Revenues for the six months ended June 30, 2024, were $7.4 million, an increase of $4.1 million from $3.3 million in the same period of 2023 [107]. - Total operating expenses for the three months ended June 30, 2024, were $7.5 million, an increase of approximately 27.7% from $5.8 million in the same period of 2023 [105]. - Total operating expenses for the six months ended June 30, 2024, were $12.6 million, an increase of approximately 5.6% from $11.9 million in the same period of 2023 [107]. - The company incurred an accumulated deficit of $292.6 million through June 30, 2024, primarily due to research and development activities and general administrative expenses [110]. Research and Development Expenses - Research and development expenses decreased to $2.8 million for the three months ended June 30, 2024, from $4.2 million in the same period of 2023, a reduction of approximately 31.9% [106]. - Research and development expenses for the six months ended June 30, 2024, were $6.3 million, down from $8.0 million in the same period of 2023, a decrease of approximately 21.1% [107]. - Research and development expenses decreased to $6.3 million for the six months ended June 30, 2024, down approximately $1.7 million (21.25%) from $8.0 million for the same period in 2023, mainly due to winding down the PUR1900 Phase 2b clinical trial [108]. General and Administrative Expenses - General and administrative expenses increased to $2.0 million for the three months ended June 30, 2024, compared to $1.7 million in the same period of 2023, an increase of approximately 17.6% [106]. - General and administrative expenses were $3.6 million for the six months ended June 30, 2024, a decrease of approximately $0.3 million (7.69%) from $3.9 million for the same period in 2023 [109]. Cash Flow and Financing - Total cash and cash equivalents as of June 30, 2024, were $12.4 million, with an additional $1.4 million in short-term restricted cash becoming available for operations in August 2024 [110]. - Net cash used in operating activities for the six months ended June 30, 2024, was $6.4 million, compared to $9.8 million for the same period in 2023, reflecting a decrease of $3.4 million (34.69%) [113][115]. - No cash was provided by financing activities for the six months ended June 30, 2024, while $0.053 million was provided in the same period of 2023 from the issuance of common stock [117]. - The company is exploring financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100 [111]. Future Outlook - The company plans to continue incurring substantial expenses and operating losses for several years as it advances its drug development plans, particularly for PUR3100 [74]. - The company expects to continue incurring losses over the next several years due to development costs associated with its iSPERSE pipeline programs, contingent on obtaining financing or partnerships [111]. - The company anticipates completing all Phase 2b wind down activities within the third quarter of 2024 [96]. Market Conditions - The ongoing geopolitical conflicts and the end of the COVID-19 public health emergency may adversely impact the company's business and operations, contributing to increased market volatility [121].

Cross license involves Pulmatrix iSPERSE™ technology and MannKind's Cricket® inhalation device. Pulmatrix transferring leased building, all leasehold improvements, laboratory equipment and other related personal property in exchange for MannKind assumption of lease. For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html. About PUR3100 PUR3100 is an orally inhaled formulation of dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute mig ...

Core Insights - Pulmatrix, Inc. has developed PUR3100, an orally inhaled formulation of dihydroergotamine (DHE), which shows potential for rapid pain relief and improved tolerability compared to intravenous DHE [2][3] - The Phase 1 study results indicate that PUR3100 has a Tmax of 5 minutes and a Cmax within the therapeutic window, suggesting its efficacy for acute migraine treatment [3] - The company is seeking financing or partnerships to advance PUR3100 into a Phase 2 clinical study [4] Company Overview - Pulmatrix is a clinical-stage biopharmaceutical company focused on innovative inhaled therapies for serious central nervous system and pulmonary diseases using its patented iSPERSE™ technology [2][9] - The company aims to address significant unmet medical needs, particularly in the treatment of acute migraine and other CNS disorders [9] Product Details - PUR3100 is engineered with iSPERSE™ technology, which allows for efficient drug delivery and deep lung penetration, addressing limitations of conventional inhaled therapies [5][6] - The Phase 1 trial demonstrated that all doses of PUR3100 were well tolerated, with significantly lower incidences of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%) compared to IV DHE [3] Clinical Study Insights - The Phase 1 study was a randomized, double-blind trial comparing inhaled PUR3100 with IV DHE, showing optimal pharmacokinetics and improved tolerability [3] - The pharmacokinetic profile of PUR3100 included a reduced AUC0–2h (1120–4320 vs. 6340) and a lower Cmax (3620–14,400 vs. 45,000), while maintaining efficacy levels above 1000 pg/mL [3] Market Context - Over 38 million patients in the United States suffer from migraines, and currently, there is no orally inhaled DHE treatment option available [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q PULMATRIX, INC. (Exact name of registrant as specified in its charter) Delaware 46-1821392 (State or other jurisdiction of incorporation or organization) (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, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ ...