Pulmatrix Reports Q1 2024 Financial Results and Corporate Update
Pulmatrix, Inc., a clinical-stage biopharmaceutical company known for its innovative inhaled therapies, recently released its financial results for the first quarter of 2024 and provided updates on its development programs. The company's focus is on treating serious central nervous system and pulmonary diseases using its patented iSPERSE™ technology.
As of the end of Q1 2024, Pulmatrix held $16.3 million in cash and cash equivalents, projecting sufficient funds to maintain operations into the first quarter of 2026. The company has implemented strategic cost-saving measures, which include the wind-down of the Phase 2b study for PUR1900. This decision stems from an agreement with its partner Cipla, which will now take full responsibility for developing PUR1900, concentrating on markets with significant unmet needs and a faster approval trajectory outside the U.S.
Ted Raad, CEO of Pulmatrix, emphasized that the company’s efforts in the first quarter were geared towards cost-saving measures and exploring strategic alternatives that leverage the potential of PUR3100 and the iSPERSE™ technology.
Key highlights from the first quarter of 2024 include:
PUR3100 Development
Pulmatrix announced the FDA's acceptance of an IND application for PUR3100 in 2023, accompanied by a "study may proceed" letter for a Phase 2 study. This study aims to investigate the safety and preliminary efficacy of PUR3100, an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™, in patients suffering from acute migraines. Phase 1 results, presented at the American Headache Society 65th Annual Meeting, indicated that PUR3100 achieved peak exposures within the targeted therapeutic range, with the maximum concentration occurring five minutes post-dosing. The results also showed lower incidences of nausea and no vomiting compared to intravenous DHE administration. Pulmatrix is currently exploring financing or partnership options to initiate a potential Phase 2 study for PUR3100.
PUR1800 Progress
In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The study indicated that PUR1800 was safe and well-tolerated, without any observed safety signals. These results, combined with data from chronic toxicology studies, support the continued development of PUR1800 for AECOPD and other inflammatory respiratory diseases. Pulmatrix is looking into partnerships or alternative methods to advance or monetize PUR1800.
PUR1900 Update
Pulmatrix, in collaboration with Cipla, decided to halt patient enrollment for the Phase 2b study of PUR1900, an inhaled iSPERSE™ formulation of the antifungal drug itraconazole. This decision was not due to safety concerns but was part of a strategic move to optimize resource allocation. Pulmatrix aims to complete all Phase 2b wind-down activities by the third quarter of 2024. Post-wind-down, Pulmatrix will not bear any financial responsibility for PUR1900’s development and will receive royalties on future net sales by Cipla outside the U.S. Within the U.S., both companies plan to monetize PUR1900.
Financial Performance
Revenue for Q1 2024 increased to $5.9 million compared to $1.5 million in Q1 2023. This significant rise was due to a contract modification with Cipla for PUR1900, resulting in a cumulative catch-up adjustment in non-cash revenue. Research and development expenses saw a reduction of approximately $0.4 million, totaling $3.5 million. General and administrative expenses also decreased by $0.6 million, amounting to $1.6 million. Overall, Pulmatrix reported a net income increase of $5.2 million, reaching $0.8 million for Q1 2024, compared to a net loss of $4.4 million in Q1 2023.
Pulmatrix is committed to advancing its pipeline of inhaled therapeutic products aimed at treating CNS disorders, serious lung diseases, and other conditions with unmet medical needs using its iSPERSE™ technology.
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