Pulmatrix(PULM) - 2022 Q4 - Annual Report

Product Development - The company is developing inhaled therapies for serious pulmonary diseases and CNS disorders using its patented iSPERSE technology[264]. - Current product pipeline includes PUR1900 for allergic bronchopulmonary aspergillosis (ABPA), PUR3100 for acute migraine, and PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD)[267]. - PUR3100 aims to be the first orally inhaled dihydroergotamine (DHE) treatment for acute migraine, targeting over 38 million migraine sufferers in the U.S.[280]. - Phase 1 clinical study of PUR3100 showed it was well-tolerated with a lower incidence of nausea compared to IV DHE, with peak exposures in the therapeutic range[283][284]. - The company plans to open an IND in Q2 2023 for a Phase 2 clinical study of PUR3100, pending financing or partnership arrangements[286]. - PUR1800 completed Phase 1b safety and pharmacokinetics study, showing no safety signals and consistent systemic exposure[287][289]. - The Cipla Agreement for PUR1900 includes a 60/40 cost-sharing arrangement for overhead costs and a potential 50/50 sharing of direct costs upon milestone achievement[274]. - The company intends to form strategic alliances to advance clinical trials and leverage the iSPERSE platform for partnered compounds[268]. Financial Performance - Revenue for the year ended December 31, 2022, was $6.1 million, an increase of $0.9 million from $5.2 million in 2021, primarily due to $4.6 million more revenues under the Cipla Agreement[312]. - Research and development expenses for 2022 were $18.2 million, up approximately $2.8 million from $15.4 million in 2021, driven by increased spending on the PUR1900 program[313]. - The JJEI License Agreement was terminated on July 6, 2021, resulting in a decrease of $3.7 million in license-related revenues[291][312]. - The total operating expenses for 2022 were $25.0 million, a slight decrease from $25.3 million in 2021[312]. - The net loss for the year ended December 31, 2022, was $18.8 million, an improvement from a net loss of $20.2 million in 2021[312]. - General and administrative expenses increased to $6.8 million in 2022 from $6.4 million in 2021, a rise of approximately 6.25% due to higher professional services costs[314]. - The accumulated deficit reached $273.5 million as of December 31, 2022, primarily from research and development expenses[315]. - Cash and cash equivalents totaled $35.6 million as of December 31, 2022, expected to fund operations for at least the next 12 months[317]. - Net cash used in operating activities was $19.4 million in 2022, compared to $19.7 million in 2021, reflecting a slight decrease of 1.5%[320][321]. - Net cash provided by financing activities dropped significantly to $1.2 million in 2022 from $43.5 million in 2021, a decrease of approximately 97.24%[323]. Future Outlook - The company expects to incur significant expenses and increasing operating losses for several years as it advances its drug development plans[269]. - The company anticipates continued losses due to development costs associated with the iSPERSE™ pipeline programs, necessitating additional capital[316]. - The company is exploring financing or partnership arrangements to support the development of its drug candidates, including a potential Phase 2 clinical study for PUR3100[316]. - General and administrative expenses are expected to increase in the future due to compliance costs associated with being a public company[297]. - The ongoing COVID-19 pandemic and geopolitical tensions may adversely impact the company's operations and capital raising efforts[329]. Staffing and Operations - Approximately 83% of the company's staff are dedicated to research and development activities, supporting the advancement of product development[295]. - The company maintains a 22,000 square foot office and research facility, which includes capital equipment for manufacturing and characterizing iSPERSE powders[295]. - The company has not generated any revenue from product sales and will seek funding through equity or debt financings, licensing arrangements, and collaborations[269]. - The company has not generated any product sales to date, with revenues derived from collaboration and license agreements[292]. - The company has no material off-balance sheet arrangements that could significantly affect its financial condition[318]. - Interest income for 2022 was $309,000, a significant increase from $7,000 in 2021[312]. - The company sold 252,013 shares of common stock in 2022 at a weighted-average price of approximately $5.70 per share, generating net proceeds of about $1.4 million[324].