On August 10, 2023 Pulmatrix (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE technology, reported second quarter financial results for 2023 and provided a corporate update on its development programs (Press release, Pulmatrix, AUG 10, 2023, View Source [SID1234634209]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ted Raad, Chief Executive Officer of Pulmatrix commented, "With our first quarter initiation of the PUR1900 Phase 2b study in allergic bronchopulmonary aspergillosis, or ABPA, our focus for the second quarter was both to continue our work on the PUR1900 trial as well as to file an Investigational New Drug Application, or IND, for a Phase 2 trial for PUR3100 for the treatment of acute migraine, which we achieved in June 2023. We anticipate starting the PUR3100 trial once appropriate financing or partnerships have been arranged. While we advance all of our programs clinically, we have focused on driving operational efficiencies and have extended our projected cash runway into the first quarter of 2025."

Second Quarter 2023 and Recent Program and Corporate Highlights

PUR1900

PUR1900 is currently in a Phase 2 trial for the treatment of ABPA in patients with asthma (). In February 2023, Pulmatrix began dosing patients for its proof-of-concept Phase 2b study of PUR1900 (itraconazole, administered as a dry powder for inhalation using iSPERSE). This Phase 2b trial is a randomized, double-blind, multi-center, placebo-controlled study to evaluate PUR1900’s efficacy and safety. The multi-center study is being conducted in the United States, United Kingdom, Australia and France. Endpoints include safety, tolerability, and potential efficacy outcomes to identify potential registrational endpoints in adult patients with asthma and ABPA. Pulmatrix anticipates topline data from this study in the third quarter of 2024.
PUR3100

The Company submitted an IND to the United States Food and Drug Administration for PUR3100 in June 2023. PUR3100 is under development as an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE for the acute treatment of migraine. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Company is pursuing potential partnership opportunities.
Data from the Phase 1 study, completed last year, was presented at the American Headache Society 65th Annual Meeting in June 2023. Results showed a lower incidence of nausea, and no vomiting was observed in PUR3100 dose groups compared to intravenously (IV) administered DHE. The study also 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.
PUR1800

In February 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The topline data was initially announced in March 2022, at the American Academy of Allergy, Asthma & Immunology annual conference. The completed data analysis will inform the study design of a potential Phase 2 study in patients with AECOPD. Pulmatrix plans to pursue partnership opportunities to advance PUR1800 into a potential Phase 2 clinical trial.
Second Quarter 2023 Financial Results

Revenues increased $0.5 million to $1.8 million for the three months ended June 30, 2023 compared to $1.3 million for the three months ended June 30, 2022. The increase 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 $0.2 million to $4.2 million for the three months ended June 30, 2023 compared to $4.3 million for the three months ended June 30, 2022. The decrease was primarily due to decreased spend of $0.8 million in costs related to the Company’s PUR3100 program and $0.1 million in costs related to the Company’s PUR1800 program, partially offset by increases in spending of $0.5 million in costs related to the Company’s PUR1900 program and $0.2 million of employment and operating costs.

General and administrative expenses increased $0.1 million to $1.7 million for the three months ended June 30, 2023, compared to $1.6 million for the three months ended June 30, 2022. The increase was primarily due to increased professional services costs.

Pulmatrix’s total cash and cash equivalents balance as of June 30, 2023 was $25.8 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.