Patient enrollment for the Phase 2b study of PUR1900 is ongoing with four additional sites added during Q3, totaling seventeen active sites to date in four countries; topline data anticipated in H2 2024
Received "study may proceed" letter on an IND for a Phase 2 study of PUR3100 for acute migraine
$21.3 million in cash and cash equivalents at the end of Q3 2023 providing projected cash runway into Q1 2025
BEDFORD, Mass., Nov. 9, 2023 /PRNewswire/ -- Pulmatrix, Inc. (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented dry powder inhalation iSPERSE™ technology, today announced third quarter financial results for 2023 and provided a corporate update on its development programs.
Ted Raad, Chief Executive Officer of Pulmatrix commented, "Our PUR1900 Phase 2b study in allergic bronchopulmonary aspergillosis, or ABPA, is ongoing with newly activated sites now contributing to enrollment efforts. With receipt of the FDA "study may proceed" letter for PUR3100 announced in September 2023, we anticipate initiating the PUR3100 Phase 2 study once appropriate financing or partnership has been arranged. While we continue to advance our clinical programs, we believe we have maintained operational efficiency to preserve our projected cash runway into the first quarter of 2025."
Third Quarter 2023 and Recent Program and Corporate Highlights
Third Quarter 2023 Financial Results
Revenues decreased $0.1 million to $1.8 million for the three months ended September 30, 2023 compared to $1.9 million for the three months ended September 30, 2022. The decrease is related to the Company's revenues recognized in accordance with the Cipla Agreement for PUR1900 during the period.
Research and development expenses decreased approximately $1.3 million to $4.0 million for the three months ended September 30, 2023 compared to $5.3 million for the three months ended September 30, 2022. The decrease was primarily due to decreased spend of $0.7 million in costs related to the Company's PUR3100 program, $0.4 million in costs related to the Company's PUR1900 program, $0.1 million in costs related to the Company's PUR1800 program and $0.1 million of employment and operating costs.
General and administrative expenses remained at $1.7 million for both the three months ended September 30, 2023 and 2022, as an increase in facilities costs was offset by a decrease in personnel costs.
Pulmatrix's total cash and cash equivalents balance as of September 30, 2023 was $21.3 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 2025.
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Preferred stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at September 30, 2023 and December 31, 2022
Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 and 3,639,185 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
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About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases and central nervous system ("CNS") disorders using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for lung diseases, such as allergic bronchopulmonary aspergillosis ("ABPA"), Chronic Obstructive Pulmonary Disease ("COPD") and CNS disorders such as acute migraine. 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.
For more on our inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html.
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 impact of the novel coronavirus (COVID-19) endemic on the Company's ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on 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.
Timothy McCarthy, CFA
SOURCE Pulmatrix Inc.