Post by icemandios on May 12, 2023 13:12:25 GMT
Pulmatrix Announces First Quarter 2023 Financial Results And Provides Corporate Update
PR Newswire
Patient dosing initiated for Phase 2b study of PUR1900 for ABPA
Phase 1 study of PUR3100 for migraine achieves positive topline results
$30.8 million in cash and cash equivalents at the end of Q1 2023 providing projected cash runway into Q4 2024
LEXINGTON, Mass. , May 12, 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 iSPERSE™ technology, today announced first quarter financial results for 2023 and provided a corporate update on its development programs.
(PRNewsfoto/Pulmatrix, Inc.)
Ted Raad , Chief Executive Officer of Pulmatrix commented, "Our focus in the first quarter was to advance both PUR1900 and PUR3100. We initiated patient dosing for the PUR1900 Phase 2b study in allergic bronchopulmonary aspergillosis (ABPA). This is an important milestone for PUR1900 which has the potential to be the first product approved for treatment of ABPA, a disease with high unmet need that affects more than 300,000 patients in the United States ." Mr. Raad continued, "We also announced topline results for a Phase 1 study of PUR3100, our orally inhaled formulation of dihydroergotamine (DHE) being developed for the treatment of acute migraine. Based on these Phase 1 results, we are eager to advance PUR3100 into Phase 2 and plan to file an Investigational New Drug Application (IND) in mid-2023. We anticipate that PUR3100 will be Phase 2 ready by mid-year so that we are well positioned for potential partnership discussions. While we advance all of our programs clinically, we have been keenly focused on driving operational efficiencies and have extended our projected cash runway from second quarter 2024 into the fourth quarter of 2024."
First Quarter 2023 and Recent Program and Corporate Highlights
PUR1900
PUR3100
PUR1800
First Quarter 2023 Financial Results
Revenues increased $0.3 million to $1.5 million for the three months ended March 31, 2023 compared to $1.2 million for the three months ended March 31, 2022 . The increase is related to the Company's revenues recognized in accordance with the Cipla Agreement during the period.
Research and development expenses decreased $0.2 million to $3.9 million for the three months ended March 31, 2023 compared to $4.1 million for the three months ended March 31, 2022 . The decrease was primarily due to decreased spend of $0.6 million in costs related to the Company's PUR3100 program and $0.3 million in costs related to the Company's PUR1800 program, partially offset by increased spend of $0.6 million in costs related to the Company's PUR1900 program.
General and administrative expenses increased $0.2 million to $2.2 million for the three months ended March 31, 2023 , as compared to $2.0 million for the three months ended March 31, 2022 . The increase was primarily due to increased legal and professional services costs.
PR Newswire
Patient dosing initiated for Phase 2b study of PUR1900 for ABPA
Phase 1 study of PUR3100 for migraine achieves positive topline results
$30.8 million in cash and cash equivalents at the end of Q1 2023 providing projected cash runway into Q4 2024
LEXINGTON, Mass. , May 12, 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 iSPERSE™ technology, today announced first quarter financial results for 2023 and provided a corporate update on its development programs.
(PRNewsfoto/Pulmatrix, Inc.)
Ted Raad , Chief Executive Officer of Pulmatrix commented, "Our focus in the first quarter was to advance both PUR1900 and PUR3100. We initiated patient dosing for the PUR1900 Phase 2b study in allergic bronchopulmonary aspergillosis (ABPA). This is an important milestone for PUR1900 which has the potential to be the first product approved for treatment of ABPA, a disease with high unmet need that affects more than 300,000 patients in the United States ." Mr. Raad continued, "We also announced topline results for a Phase 1 study of PUR3100, our orally inhaled formulation of dihydroergotamine (DHE) being developed for the treatment of acute migraine. Based on these Phase 1 results, we are eager to advance PUR3100 into Phase 2 and plan to file an Investigational New Drug Application (IND) in mid-2023. We anticipate that PUR3100 will be Phase 2 ready by mid-year so that we are well positioned for potential partnership discussions. While we advance all of our programs clinically, we have been keenly focused on driving operational efficiencies and have extended our projected cash runway from second quarter 2024 into the fourth quarter of 2024."
First 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 ( NCT05667662 ). 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). 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 expects to report topline data from this study in mid-2024.
PUR3100 is under development as an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™ for the acute treatment of migraine. On January 4, 2023 , Pulmatrix announced PUR3100 was well-tolerated and there was 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. Pulmatrix plans to present the data at an appropriate upcoming scientific conference.
Based on the rapid systemic exposure in the therapeutic range and the improved side effect profile compared to IV dosing, Pulmatrix believes the PUR3100 formulation of DHE will be differentiated from other products approved or in development. Pulmatrix believes that PUR3100's potential for convenient self-administration and a pharmacokinetic profile demonstrated in studies to date could address unmet needs for patients with acute migraine.
Pulmatrix plans to submit an IND in mid-2023 for a randomized, placebo-controlled, Phase 2 clinical study of PUR3100 in patients with acute migraine. The Phase 2 study would assess the safety and effectiveness of two dose levels of PUR3100, selected based on the initial Phase 1 clinical study. Initiation of the Phase 2 study is pending potential financing or partnership.
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 is expected to 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.
Revenues increased $0.3 million to $1.5 million for the three months ended March 31, 2023 compared to $1.2 million for the three months ended March 31, 2022 . The increase is related to the Company's revenues recognized in accordance with the Cipla Agreement during the period.
Research and development expenses decreased $0.2 million to $3.9 million for the three months ended March 31, 2023 compared to $4.1 million for the three months ended March 31, 2022 . The decrease was primarily due to decreased spend of $0.6 million in costs related to the Company's PUR3100 program and $0.3 million in costs related to the Company's PUR1800 program, partially offset by increased spend of $0.6 million in costs related to the Company's PUR1900 program.
General and administrative expenses increased $0.2 million to $2.2 million for the three months ended March 31, 2023 , as compared to $2.0 million for the three months ended March 31, 2022 . The increase was primarily due to increased legal and professional services costs.
Pulmatrix's total cash and cash equivalents balance as of March 31, 2023 was $30.8 million . The Company anticipates that its cash position is sufficient to fund operations into the fourth quarter of 2024.
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.
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.