BEDFORD - Pulmatrix, Inc. ( Pulmatrix or the Company ) (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious central nervous system and pulmonary disease using its patented dry powder inhalation iSPERSE technology, today announced first quarter financial results for 2024 and provided a corporate update on its development programs.
Ted Raad, Chief Executive Officer of Pulmatrix, commented, Our focus in the first quarter has been to continue our cost saving measures including the wind down of the Phase 2b study for PUR1900 and on strategic alternatives that leverage the potential of PUR3100, iSPERSE technology and our extended cash resources.
First Quarter 2024 and Recent Program and Corporate Highlights
PUR3100
In 2023, Pulmatrix announced the FDA s acceptance of an IND application for PUR3100 and receipt of a study may proceed letter for a Phase 2 study, positioning PUR3100 as Phase 2-ready. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100, an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE, will be investigated in patients with acute migraine.
The planned Phase 2 trial builds on the Phase 1 trial results, which were published in 2023 and presented at the American Headache Society 65th Annual Meeting in June 2023. The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously (IV) administered DHE dose group.
Pulmatrix is currently exploring financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100.
PUR1800
In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD), indicating PUR1800 was safe and well tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases.
Pulmatrix plans to pursue partnership or other alternatives to monetize or advance PUR1800.
PUR1900
In agreement with its partner Cipla, Pulmatrix has stopped patient enrollment for the Phase 2b study of PUR1900. PUR1900 is the Company s inhaled iSPERSE formulation of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. The decision to stop the study was unrelated to any safety concerns. This study had been ongoing since the first quarter of 2023. The Company remains on track to complete all Phase 2b wind down activities by the third quarter of 2024.
After the study wind down, Pulmatrix will bear no further financial responsibility for the development of PUR1900 and will receive 2% royalties on any potential future net sales by Cipla outside the United States. Within the United States, Pulmatrix and Cipla will seek to monetize PUR1900.
First Quarter 2024 Financial Results
Revenues increased $4.4 million to $5.9 million for the three months ended March 31, 2024, compared to $1.5 million for the three months ended March 31, 2023. The increase is primarily related to a contract modification of the Cipla Agreement for PUR1900 which resulted in a cumulative catch-up adjustment in non-cash revenue recorded during the three months ended March 31, 2024. The amount of the cumulative catch-up had been included in deferred revenue at the beginning of the period.
Research and development expenses decreased approximately $0.4 million to $3.5 million for the three months ended March 31, 2024, compared to $3.9 million for the three months ended March 31, 2023. The decrease was primarily due to decreased spend of $0.2 million in costs related to the Company s PUR3100 program and $0.2 million in employment costs.
General and administrative expenses decreased $0.6 million to $1.6 million for the three months ended March 31, 2024, compared to $2.2 million for the three months ended March 31, 2023. The decrease was primarily due to decreased spend of $0.4 million in legal and professional services costs and $0.2 million in employment costs.
Net income increased $5.2 million to $0.8 million for the three months ended March 31, 2024, compared to a net loss of $4.4 million for the three months ended March 31, 2023. The increase is primarily related to the contract modification of the Cipla Agreement for PUR1900, mentioned above, which resulted in a cumulative catch-up adjustment in non-cash revenue recorded during the three months ended March 31, 2024.
The Company s total cash and cash equivalents balance as of March 31, 2024, was $16.3 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations into the first quarter of 2026.
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat central nervous system ( CNS ), respiratory and other diseases with important unmet medical needs using its patented iSPERSE technology. The Company s proprietary product pipeline includes treatments for CNS disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease ( COPD ) and allergic bronchopulmonary aspergillosis ( ABPA ). Pulmatrix s product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
Forward-Looking Statements
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as anticipates, assumes, believes, can, could, estimates, expects, forecasts, guides, intends, is confident that , may, plans, seeks, projects, targets, and would, and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the Company s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Timothy McCarthy
Tel: 917-679-9282
Email: tim@lifesciadvisors.com
PULMATRIX, INC. 
