Post by icemandios on Nov 10, 2022 15:20:40 GMT
Pulmatrix Announces Third Quarter 2022 Financial Results and Provides Corporate Update
PR Newswire
PUR1900 (Pulmazole) on track for Phase 2 study start in Q1 2023
PUR3100 Phase 1 study top line data anticipated in early Q1 2023
$40.7 million in cash and cash equivalents at end of Q3 2022
LEXINGTON, Mass. , Nov. 10, 2022 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious disease using its patented iSPERSE™ technology, today announced third quarter financial results for 2022 and provided a corporate update related to its development programs.
Ted Raad , Chief Executive Officer of Pulmatrix commented, "In this quarter we have advanced both PUR3100 and PUR1900 towards important data catalysts. We completed patient dosing for PUR3100, our orally inhaled dihydroergotamine (DHE) being developed for the treatment of acute migraine, in a Phase 1 study with data expected to be released in early Q1 2023. In addition to safety and tolerability, the study will evaluate the pharmacokinetics of PUR3100 compared to intravenous DHE. This will allow us to better understand the potential efficacy and tolerability profile of PUR3100, which we believe could be beneficial to patients suffering from acute migraine. We also commenced study start-up activities for the PUR1900 Phase 2 study and remain on track to initiate patient dosing in the first quarter of 2023. PUR1900 has the potential to be the first approved therapy for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma."
Third Quarter 2022 and Recent Program Highlights
PUR1900 in development for ABPA
Pulmatrix initiated study start-up activities for the Phase 2 safety and efficacy study of PUR1900 in patients with asthma and ABPA. This will include a 16-week dosing regimen and endpoints that would potentially support a Phase 3 trial.
PUR3100 in development for acute migraine
On September 26, 2022 , Pulmatrix announced completion of patient dosing in its Phase 1 trial evaluating PUR3100.
Phase 1 study database lock to occur in November with top-line data anticipated to be released in early Q1 2023.
PUR1800 in development for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Pulmatrix is analyzing data from the completed Phase 1b clinical study of PUR1800 for AECOPD for presentation at a relevant medical conference in 2023. These data will inform the design of a potential Phase 2 study in the treatment of AECOPD.
Third Quarter 2022 Financial Results
Revenues increased $0.8 million to $1.9 million for the three months ended September 30, 2022 compared to $1.1 million for the same period in 2021. The increase in revenue was due to $1.9 million in revenue in the three months ended September 30, 2022 for the PUR1900 program related to the Cipla Agreement compared to no revenues for the three months ended September 30, 2021 . This was partially offset by no revenues in the three months ended September 30, 2022 for the PUR1800 program compared to $1.1 million for the three months ended September 30, 2021 .
For the three months ended September 30, 2022 , research and development expenses increased $1.3 million to $5.3 million compared to $4.0 million for the same period in 2021. The increase was primarily due to increased spending of $1.5 million in clinical costs related to the PUR1900 program, $0.6 million in employment costs and $0.2 million in facility costs. This amount was partially offset by a $1.0 million decrease in non-clinical and clinical costs related to the PUR1800 program.
General and administrative expenses were unchanged at $1.7 million for the three months ended September 30, 2022 compared to the same period in 2021.
During the three months ended September 30, 2022 , the Company sold 252,013 shares of its common stock at a weighted-average price of approximately $5.70 per share, for net proceeds of approximately $1.4 million , under the At-The-Market Sales Agreement established with H.C. Wainwright & Co., LLC in May 2021 .
Cash and cash equivalents as of September 30, 2022 was $40.7 million . As of November 10, 2022 , Pulmatrix expects its existing cash and cash equivalents will enable it to fund operating expenses and capital expenditure into the second quarter of 2024.
Financial Tables
PR Newswire
PUR1900 (Pulmazole) on track for Phase 2 study start in Q1 2023
PUR3100 Phase 1 study top line data anticipated in early Q1 2023
$40.7 million in cash and cash equivalents at end of Q3 2022
LEXINGTON, Mass. , Nov. 10, 2022 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious disease using its patented iSPERSE™ technology, today announced third quarter financial results for 2022 and provided a corporate update related to its development programs.
Ted Raad , Chief Executive Officer of Pulmatrix commented, "In this quarter we have advanced both PUR3100 and PUR1900 towards important data catalysts. We completed patient dosing for PUR3100, our orally inhaled dihydroergotamine (DHE) being developed for the treatment of acute migraine, in a Phase 1 study with data expected to be released in early Q1 2023. In addition to safety and tolerability, the study will evaluate the pharmacokinetics of PUR3100 compared to intravenous DHE. This will allow us to better understand the potential efficacy and tolerability profile of PUR3100, which we believe could be beneficial to patients suffering from acute migraine. We also commenced study start-up activities for the PUR1900 Phase 2 study and remain on track to initiate patient dosing in the first quarter of 2023. PUR1900 has the potential to be the first approved therapy for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma."
Third Quarter 2022 and Recent Program Highlights
PUR1900 in development for ABPA
Pulmatrix initiated study start-up activities for the Phase 2 safety and efficacy study of PUR1900 in patients with asthma and ABPA. This will include a 16-week dosing regimen and endpoints that would potentially support a Phase 3 trial.
PUR3100 in development for acute migraine
On September 26, 2022 , Pulmatrix announced completion of patient dosing in its Phase 1 trial evaluating PUR3100.
Phase 1 study database lock to occur in November with top-line data anticipated to be released in early Q1 2023.
PUR1800 in development for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Pulmatrix is analyzing data from the completed Phase 1b clinical study of PUR1800 for AECOPD for presentation at a relevant medical conference in 2023. These data will inform the design of a potential Phase 2 study in the treatment of AECOPD.
Third Quarter 2022 Financial Results
Revenues increased $0.8 million to $1.9 million for the three months ended September 30, 2022 compared to $1.1 million for the same period in 2021. The increase in revenue was due to $1.9 million in revenue in the three months ended September 30, 2022 for the PUR1900 program related to the Cipla Agreement compared to no revenues for the three months ended September 30, 2021 . This was partially offset by no revenues in the three months ended September 30, 2022 for the PUR1800 program compared to $1.1 million for the three months ended September 30, 2021 .
For the three months ended September 30, 2022 , research and development expenses increased $1.3 million to $5.3 million compared to $4.0 million for the same period in 2021. The increase was primarily due to increased spending of $1.5 million in clinical costs related to the PUR1900 program, $0.6 million in employment costs and $0.2 million in facility costs. This amount was partially offset by a $1.0 million decrease in non-clinical and clinical costs related to the PUR1800 program.
General and administrative expenses were unchanged at $1.7 million for the three months ended September 30, 2022 compared to the same period in 2021.
During the three months ended September 30, 2022 , the Company sold 252,013 shares of its common stock at a weighted-average price of approximately $5.70 per share, for net proceeds of approximately $1.4 million , under the At-The-Market Sales Agreement established with H.C. Wainwright & Co., LLC in May 2021 .
Cash and cash equivalents as of September 30, 2022 was $40.7 million . As of November 10, 2022 , Pulmatrix expects its existing cash and cash equivalents will enable it to fund operating expenses and capital expenditure into the second quarter of 2024.
Financial Tables