Pulmazole is on the way for the phase 2b start of the study in the first quarter of 2023
Phase 1 PUR3100 study is ongoing with data expected in Q4 2022
End Q2 with 42.9 million dollars in cash and equivalents
LEXINGTON, Mass., August 8, 2022 /PRNewswire/ — Pulmatrix, Inc. (NASDAQ: WEDDING), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious diseases using its proprietary iSPERSE™ technology, today announced second quarter 2022 financial results and provided a corporate update related to its development programs.
Ted Raad, CEO of Pulmatrix commented, “Our focus this quarter has been on advancing both PUR3100 and Pulmazole to significant data catalysts. We initiated dosing of PUR3100, our inhaled dihydroergotamine (DHE) orally, in a phase 1 study with data expected in Q4 2022. In addition to safety and tolerability, the study will evaluate the pharmacokinetics of PUR3100 and intravenous dihydroergotamine (DHE), allowing us to better understand the potential profile of ‘efficacy and tolerability of PUR3100’. Mr. Raad continued, “We also began study initiation activities for the Pulmazole Phase 2b study and are on track to begin dosing in patients in the first quarter of 2023. Pulmazole has the potential to be the first approved therapy for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.” .
Second quarter 2022 and recent program highlights
Pulmatrix initiated study start-up activities for the Phase 2b efficacy study of Pulmazole, which will include a 16-week dosing regimen and potential registration endpoints that could support a registration trial.
Turned on July 12, 2022Pulmatrix announced the dosing of the first five subjects in a Phase 1 trial. To date, the trial has enrolled 23 of 24 patients and top-line data is expected in the fourth quarter of 2022.
Pulmatrix is analyzing the data from the completed Phase 1b clinical study of PUR1800 for future publications and perform further modeling to inform Phase 2 study design.
Financial results for the second quarter of 2022
The income was 1.3 million dollars because the second quarter is over June 30, 2022compared to 2.2 million dollars for the same period in 2021, a decrease of 0.9 million dollars. The decrease in revenue was due to no revenue being recorded during this period for the PUR1800 program offset by a 1.0 million dollars revenue increase recorded in this period over the same period in 2021 in the Cipla deal for Pulmazole (PUR1900).
For the past three months June 30, 2022research and development expenses were 4.3 million dollars compared to 4.5 million dollars for the same period in 2021, a decrease of 0.2 million dollars. The decrease was mainly due to the decrease in the expenditure of 0.9 million dollars in preclinical and clinical costs related to the PUR 1800 program and 0.5 million dollars in preclinical and manufacturing costs related to the PUR 3100 program, partially offset by increased spending on 0.6 million dollars in clinical and manufacturing costs related to the Pulmazole program, 0.5 million dollars in labor costs and 0.1 million dollars in the costs of the facilities.
General and administrative expenses remained unchanged a 1.6 million dollars during the past three months June 30, 2022 compared to the same period in 2021.
Total balance of cash and cash equivalents June 30, 2022 was 42.9 million dollars. Pulmatrix expects its existing cash and equivalents as of this time June 30, 2022 will allow it to fund operating expenses and capital expenditures during the second quarter of 2024.
Turned on February 28Pulmatrix completed a 1-for-20 reverse stock split (the “Reverse Split”) that reduced the number of outstanding shares of the Company’s common stock by approximately 65.9 million shares to 3.3 million shares.
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious lung and non-lung diseases using its proprietary iSPERSE™ technology. The company’s product portfolio includes treatments for serious lung diseases such as allergic bronchopulmonary aspergillosis (“ABPA”), chronic obstructive pulmonary disease (“COPD”) and neurological 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.
Certain statements in this letter that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to. a, statements of historical fact and may be identified by words such as “anticipates,” “assumes,” “believes,” “may,” “could,” “estimates,” “expects,” “expected,” “forecasts,” . ” “guides,” “intends,” “believes,” “may,” “plans,” “seeks,” “projects,” “goals” and “would,” and their opposites and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on management’s beliefs, as well as assumptions made by management and information currently available.Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, among others, the impact of the novel coronavirus (COVID-19) 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 businesses and raise capital in the future when necessary; delays in planned clinical trials; the ability to establish that potential products are effective or safe in preclinical or clinical trials; the ability to establish or maintain collaborations and n the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to commercialize potential products; the ability to obtain future financing for development products and working capital and to obtain such financing on commercially reasonable terms; the company’s ability to manufacture product candidates on a commercial scale or in collaboration with third parties; changes in the size and nature of competitors; the ability to retain key managers 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 SEC, including its most recent Annual Report on Form 10-K, as such may be supplemented or modified by the Company. Quarterly reports on Form 10-Q. The Company disclaims any intention or obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Pulmatrix, Inc.