#United States #Framingham #Pulmatrix #iSPERSE #Cullgen

Pulmatrix Financial Overview and Future Plans

Pulmatrix, Inc. a biopharmaceutical company publicly listed on Nasdaq (PULM), recently announced its financial results for the fourth quarter and the entire year of 2024. This report, released on March 21, 2025, includes pivotal updates regarding the company's strategic direction, particularly its proposed merger with Cullgen, Inc.

Financial Results

For the fiscal year ending December 31, 2024, Pulmatrix recorded revenues of approximately $7.8 million, an increase from the previous year's $7.3 million. This uptick is attributed to a contract modification related to the ongoing partnership with Cipla, which adjusted revenue projections upward. However, research and development expenses saw a significant drop, decreasing by about $8.4 million, bringing the total to $7.2 million. This reduction is largely due to the winding down of the PUR1900 Phase 2b clinical trial and other restructuring measures within the company.

On the other hand, general and administrative expenses rose to approximately $7.8 million, up from $6.5 million in 2023. The increase primarily reflects heightened legal and consulting fees along with one-off costs related to employee separations. Moreover, Pulmatrix acknowledged a $2.6 million loss connected with its transactions involving MannKind Corporation, which compounded the overall losses incurred, resulting in a net loss of $9.6 million for 2024, an improvement from a $14.1 million loss the previous year.

As of the end of 2024, Pulmatrix held $9.5 million in cash and cash equivalents, indicating the company’s intent to focus its financial strategies to sustain operations through the merger with Cullgen, expected to close in the first half of 2025.

Proposed Merger with Cullgen

In November 2024, Pulmatrix announced its strategy to merge with Cullgen, a privately-held biopharmaceutical company focused on targeted protein degradation technologies. This merger is anticipated to create a stronger Nasdaq-listed entity leveraging both Pulmatrix’s advanced inhalation therapies and Cullgen's proprietary drug development platforms. Peter Ludlum, the interim CEO of Pulmatrix, expressed optimism about the merger, hinting at a shared goal of advancing cancer treatments and pain relief therapies.

As part of the merger plan, Pulmatrix aims to divest several assets, including its promising acute migraine candidate, PUR3100, which is designed for oral inhalation therapy. Pulmatrix had previously gained FDA acceptance for PUR3100's Investigational New Drug application, paving the way for a Phase 2 clinical study aimed at establishing safety and preliminary efficacy in patients.

Additionally, the company plans to divest further assets related to the innovative iSPERSE™ technology, a proprietary method that significantly enhances the delivery of inhaled medications. The iSPERSE™ technology focuses on optimizing drug delivery while minimizing systemic side effects, thus enhancing therapeutic outcomes for patients with various respiratory conditions.

Clinical Asset Overview

Pulmatrix’s pipeline remains robust. Beyond PUR3100, there are other noteworthy candidates:

• - PUR1800: This Narrow Spectrum Kinase Inhibitor aims to treat acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD). After a successful Phase 1b study indicated safety and tolerability, Pulmatrix is confident in advancing this product further.

• - PUR1900: An inhaled formulation of itraconazole for fungal infections, which experienced a temporary halt in Phase 2b enrollment due to strategic reviews with its partner Cipla, demonstrating potential market realities independent of safety concerns.

Pulmatrix’s commitment to innovation through its iSPERSE™ technology is underpinned by a patent portfolio that boasts approximately 149 granted patents, with an additional 50 pending, ensuring a competitive edge in future product developments.

Conclusion

In summary, Pulmatrix's recent financial disclosures, coupled with its strategic moves towards a merger with Cullgen and an aggressive divestment of clinical assets, position the company for potential transformation. By focusing on operational efficiency and a streamlined product pipeline, Pulmatrix is adapting its business model to address critical therapeutic needs in both migraine and respiratory disease management.