Post by icemandios on Mar 23, 2021 13:09:36 GMT
Pulmatrix Reports 2020 Financial Results and Provides Business Update
Initiated PUR1800 Phase 1b study with data anticipated in Q4 2021
Pulmazole Ph2b study start anticipated Q1 2022
PUR3100 development candidate declared for pulmonary delivered DHE (dihydroergotamine) acute migraine treatment
Cash runway extends beyond all anticipated PUR1800 Ph1b, PUR3100 Ph1/Ph2, and Pulmazole Ph2b data milestones
PR Newswire
LEXINGTON, Mass. , March 23, 2021 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology, today reports its Q4 and full year 2020 financial results and provides a business update.
"In recent months, we have made important progress advancing iSPERSE enabled programs that both strengthen our foundation in respiratory indications and expand the reach of our platform to lung cancer and acute migraine," said Ted Raad , Chief Executive Officer of Pulmatrix. "Our strengthened balance sheet fully funds our operations through key data milestones across our ongoing and planned studies including the PUR1800 Phase 1b study, the PUR3100 Phase 1 / Phase 2 study and Pulmazole Phase 2b study. We look forward to a milestone rich 2021 which includes toxicology and clinical data packages from ongoing PUR1800 studies, potential license option execution from Johnson & Johnson, and continued execution as we advance therapies to address significant unmet need."
Q4 and Recent Highlights:
PUR1800
Initiated the Phase 1b clinical study of PUR1800, dosing 4 of 15 patients to date. Study endpoints include safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect. Ph1b top-line data is expected in Q4 2021, shortly after data from 6 and 9-month toxicology studies.
Completion of the PUR1800 Phase 1b will trigger a $2M milestone payment as part of the kinase inhibitor licensing and development agreement with the Lung Cancer Initiative (LCI) at Johnson & Johnson*, which was previously announced on January 2 , 2020.
Pulmazole
Successfully completed a Type C Meeting with the U.S. FDA for the further clinical development of Pulmazole.
Based on feedback from the Type C Meeting, and in accordance with our collaboration with Cipla, Pulmatrix intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) in Q1 2022, dependent on assessment of COVID-19 impact on patient safety and study operations.
PUR3100
Declared PUR3100 development candidate, a dry powder iSPERSE formulation of DHE for pulmonary delivery in acute migraine.
Completed dog PK study of PUR3100, demonstrated similar exposure kinetics to modelled kinetics from published data with MAP0004, the MAP Pharmaceuticals pMDI inhaled formulation of DHE.
Progressing IND-enabling studies with Phase 1/Phase 2 clinical study anticipated to begin Q1 2022.
Corporate:
Completed a registered direct offering with gross proceeds of $40 million extending the Company's cash through data readouts across its development pipeline including PUR1800 Phase 1b , PUR3100 Phase 1 / Phase 2, and Pulmazole Phase 2b studies.
Financials
As of December 31, 2020 , Pulmatrix had $31.7 million in cash and cash equivalents, compared to $23.4 million for the year ended December 31, 2019 .
Revenue for 2020 was $12.6 million, compared to $7.9 million for 2019. The increase resulted from an increase in revenue recorded of $6.9 million as a result of the JJEI License Agreement and includes reimbursement of pass-through expenses, partially offset by a decrease in revenue recorded of $2.2 million as a result of the Cipla Agreement.
Research and development expense was $15.6 million in 2020 compared to $12.8 million in 2019. The increase year–over–year was primarily due to increased spending on manufacturing, clinical, and preclinical study costs of $4.4 million and $0.3 million , on the PUR1800 and PUR3100 programs, respectively, $1.1 million on employment costs in support of our programs, $0.6 million in allocated fixed expenses and lab services which were partially offset by a decrease of $3.6 million on the Phase 2 Pulmazole clinical trial costs.
General and administrative expense was $6.9 million for 2020 and $8.5 million for 2019. The decrease year-over-year was primarily due to decreased employment costs of $1.2 million because of lower share-based compensation expense and salary costs, $0.1 million in patent and legal expenses and $0.3 million of a milestone payment to the CFFT made in 2019.
Goodwill was not impaired in 2020 compared to a $7.3 million impairment charge in 2019.
Net loss for 2020 was $19.3 million . The net loss in 2020 was primarily attributable to Pulmazole project costs as we advanced our Phase 2 clinical study and PUR1800 manufacturing, preclinical, and clinical study costs for the upcoming Phase 1b clinical study.
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for serious lung diseases such as allergic bronchopulmonary aspergillosis ("ABPA") and lung cancer, as well as neurologic disorders such as acute migraine. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
Initiated PUR1800 Phase 1b study with data anticipated in Q4 2021
Pulmazole Ph2b study start anticipated Q1 2022
PUR3100 development candidate declared for pulmonary delivered DHE (dihydroergotamine) acute migraine treatment
Cash runway extends beyond all anticipated PUR1800 Ph1b, PUR3100 Ph1/Ph2, and Pulmazole Ph2b data milestones
PR Newswire
LEXINGTON, Mass. , March 23, 2021 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology, today reports its Q4 and full year 2020 financial results and provides a business update.
"In recent months, we have made important progress advancing iSPERSE enabled programs that both strengthen our foundation in respiratory indications and expand the reach of our platform to lung cancer and acute migraine," said Ted Raad , Chief Executive Officer of Pulmatrix. "Our strengthened balance sheet fully funds our operations through key data milestones across our ongoing and planned studies including the PUR1800 Phase 1b study, the PUR3100 Phase 1 / Phase 2 study and Pulmazole Phase 2b study. We look forward to a milestone rich 2021 which includes toxicology and clinical data packages from ongoing PUR1800 studies, potential license option execution from Johnson & Johnson, and continued execution as we advance therapies to address significant unmet need."
Q4 and Recent Highlights:
PUR1800
Initiated the Phase 1b clinical study of PUR1800, dosing 4 of 15 patients to date. Study endpoints include safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect. Ph1b top-line data is expected in Q4 2021, shortly after data from 6 and 9-month toxicology studies.
Completion of the PUR1800 Phase 1b will trigger a $2M milestone payment as part of the kinase inhibitor licensing and development agreement with the Lung Cancer Initiative (LCI) at Johnson & Johnson*, which was previously announced on January 2 , 2020.
Pulmazole
Successfully completed a Type C Meeting with the U.S. FDA for the further clinical development of Pulmazole.
Based on feedback from the Type C Meeting, and in accordance with our collaboration with Cipla, Pulmatrix intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) in Q1 2022, dependent on assessment of COVID-19 impact on patient safety and study operations.
PUR3100
Declared PUR3100 development candidate, a dry powder iSPERSE formulation of DHE for pulmonary delivery in acute migraine.
Completed dog PK study of PUR3100, demonstrated similar exposure kinetics to modelled kinetics from published data with MAP0004, the MAP Pharmaceuticals pMDI inhaled formulation of DHE.
Progressing IND-enabling studies with Phase 1/Phase 2 clinical study anticipated to begin Q1 2022.
Corporate:
Completed a registered direct offering with gross proceeds of $40 million extending the Company's cash through data readouts across its development pipeline including PUR1800 Phase 1b , PUR3100 Phase 1 / Phase 2, and Pulmazole Phase 2b studies.
Financials
As of December 31, 2020 , Pulmatrix had $31.7 million in cash and cash equivalents, compared to $23.4 million for the year ended December 31, 2019 .
Revenue for 2020 was $12.6 million, compared to $7.9 million for 2019. The increase resulted from an increase in revenue recorded of $6.9 million as a result of the JJEI License Agreement and includes reimbursement of pass-through expenses, partially offset by a decrease in revenue recorded of $2.2 million as a result of the Cipla Agreement.
Research and development expense was $15.6 million in 2020 compared to $12.8 million in 2019. The increase year–over–year was primarily due to increased spending on manufacturing, clinical, and preclinical study costs of $4.4 million and $0.3 million , on the PUR1800 and PUR3100 programs, respectively, $1.1 million on employment costs in support of our programs, $0.6 million in allocated fixed expenses and lab services which were partially offset by a decrease of $3.6 million on the Phase 2 Pulmazole clinical trial costs.
General and administrative expense was $6.9 million for 2020 and $8.5 million for 2019. The decrease year-over-year was primarily due to decreased employment costs of $1.2 million because of lower share-based compensation expense and salary costs, $0.1 million in patent and legal expenses and $0.3 million of a milestone payment to the CFFT made in 2019.
Goodwill was not impaired in 2020 compared to a $7.3 million impairment charge in 2019.
Net loss for 2020 was $19.3 million . The net loss in 2020 was primarily attributable to Pulmazole project costs as we advanced our Phase 2 clinical study and PUR1800 manufacturing, preclinical, and clinical study costs for the upcoming Phase 1b clinical study.
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for serious lung diseases such as allergic bronchopulmonary aspergillosis ("ABPA") and lung cancer, as well as neurologic disorders such as acute migraine. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.