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Pulmatrix and Cullgen's Merger Journey

Pulmatrix, Inc. and Cullgen Inc. are currently navigating a complex merger landscape. Following their agreement in November 2024, they have granted each other certain waivers that allow for the exploration of alternative transactions while still pursuing their merger with attention from regulatory bodies. As both companies seek approval from the China Securities Regulatory Commission (CSRC), they remain committed to examining any potential opportunities that could benefit their operations.

Peter Ludlum, the Interim CEO of Pulmatrix, provided insight into the current situation, noting that their Form S-4 filing was effectively declared in May 2025, and the shareholders approved the merger in June 2025. However, facing delays in receiving necessary regulatory approvals, the companies are open to strategic options that could enhance their business models.

Proposed Merger Highlights

The merger agreement, first reached in late 2024, is designed to merge the companies' resources, especially regarding Pulmatrix's patented inhaled therapeutic products aimed at treating significant medical needs such as migraines and respiratory conditions. This collaboration could potentially reposition both entities within the biopharmaceutical landscape, enhancing their development capabilities and portfolio growth. Existing shareholder support and favorable financial conditions lay a robust foundation, but the approval from CSRC remains a crucial hurdle.

If the merger moves forward, it stands to streamline the operational structures of both Pulmatrix and Cullgen, with Cullgen anticipated to continue as part of the unified company. The successful alignment would not only bolster product development but might also attract additional investors keen on the merged entity's growth prospects within the inhaled medicine sphere.

Financial Context

As of September 30, 2025, Pulmatrix reported maintaining a cash reserve of $4.8 million, which they believe is adequate to support ongoing operational expenses into the fourth quarter of 2026. This financial stability is vital as they move toward regulatory compliance and navigate the complexities of merging with Cullgen. Furthermore, within their proprietary product pipeline, Pulmatrix continues to emphasize its innovative use of the iSPERSE™ technology for drug delivery, particularly for treatments targeting acute migraines and chronic respiratory diseases.

Pulmatrix’s Unique Clinical Assets

Products currently under development include PUR3100, a powdered inhalation treatment for migraines, which has recently entered the Phase 2 clinical trials, demonstrating promising safety profiles and efficacy. Alongside this, Pulmatrix is advancing its other assets like PUR1800 and PUR1900, both of which leverage their unique technology to enhance drug delivery and clinical outcomes.

Healthcare professionals view these therapeutic innovations with significant interest, particularly as many chronic conditions lack effective treatments. Thus, the successful merger with Cullgen could enhance Pulmatrix's ability to bring these vital medications to market more effectively.

As they continue through this pivotal time, both companies are committed to ensuring their strengths align beneficially while maintaining transparency with their stakeholders. This strategic collaboration could serve as a model for future partnerships in the biopharmaceutical industry, emphasizing the importance of regulatory navigation and innovative solutions in addressing unmet medical needs.

In summary, while Pulmatrix and Cullgen work diligently toward their merger, they remain pragmatic, ready to pivot if necessary to maximize their growth and service capabilities within a challenging regulatory environment.