On August 8, 2022 Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious disease using its patented iSPERSE technology, reported second quarter financial results for 2022 and provided a corporate update related to its development programs (Press release, Pulmatrix, AUG 8, 2022, View Source [SID1234617761]).

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Ted Raad, Chief Executive Officer of Pulmatrix commented, "Our focus this quarter has been on advancing both PUR3100 and Pulmazole towards important data catalysts. We initiated patient dosing for PUR3100, our orally inhaled dihydroergotamine (DHE), in a Phase 1 study with data anticipated in Q4 2022. In addition to safety and tolerability, the study will evaluate the pharmacokinetics of PUR3100 and intravenous dihydroergotamine (DHE). This will allow us to better understand the potential efficacy and tolerability profile of PUR3100." Mr. Raad continued, "We also commenced study start-up activities for the Pulmazole Phase 2b study and remain on track to initiate patient dosing in Q1 2023. Pulmazole has the potential to be the first approved therapy for treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Asthma."

Second Quarter 2022 and Recent Program Highlights

Pulmazole (PUR1900)

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 would potentially support a registrational trial.
PUR3100

On July 12, 2022, Pulmatrix 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 anticipated in Q4 2022.
PUR1800

Pulmatrix is analyzing data from the completed Phase 1b clinical study of PUR1800 for future publication and conducting further modeling to inform the Phase 2 study design.
Second Quarter 2022 Financial Results

Revenue was $1.3 million for the second quarter ended June 30, 2022, compared to $2.2 million for the same period in 2021, a decrease of $0.9 million. The decrease in revenue was due to no revenues recorded for this period for the PUR1800 program offset by a $1.0 million increase in revenues recorded this period over same period in 2021 on the Cipla Agreement for Pulmazole (PUR1900).

For the three months ended June 30, 2022, research and development expenses were $4.3 million compared to $4.5 million for the same period in 2021, a decrease of $0.2 million. The decrease was primarily due to decreased spending of $0.9 million in preclinical and clinical costs related to the PUR 1800 program and $0.5 million in preclinical and manufacturing costs related to the PUR 3100 program, partially offset by increased spending of $0.6 million in clinical and manufacturing costs related to the Pulmazole program, $0.5 million in employment costs and $0.1 million in facility costs.

General and administrative expenses were unchanged at $1.6 million for the three months ended June 30, 2022 compared to the same period in 2021.

Total cash and cash equivalents balance as of June 30, 2022 was $42.9 million. Pulmatrix expects its existing cash and cash equivalents as of June 30, 2022 will enable it to fund operating expenses and capital expenditure into Q2 2024.

On February 28, Pulmatrix completed a reverse stock-split at a ratio of 1-for-20 (the "Reverse Split") which reduced the number of outstanding shares of the Company’s common stock from approximately 65.9 million shares to 3.3 million shares.