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 0.5 million from 7.2 million in 2024 from 8.4 million, mainly due to decreased spending on the PUR1900 program[360]. - General and administrative expenses increased to 6.5 million in 2023, an increase of approximately 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 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 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 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 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].
Pulmatrix(PULM) - 2024 Q4 - Annual Report