Post by icemandios on Mar 28, 2024 13:16:14 GMT
Pulmatrix Announces Year-End and Q4 2023 Financial Results and Provides Corporate Update
(PRNewsfoto/Pulmatrix, Inc.)
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Pulmatrix Inc.
28 Mar, 2024, 09:05 ET
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2023 year-end $19.2 million cash and cash equivalents provide projected cash runway into Q1 2026
3rd amendment to Cipla partnership resulted in the wind down of the PUR1900 Phase 2b study and a significant reduction in expected cash burn for Pulmatrix
Cipla to take sole responsibility for development of PUR1900, refocused on markets with greatest unmet need and faster path to approval, in exchange for 2% royalty on net sales payable to Pulmatrix
BEDFORD, Mass., March 28, 2024 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious central nervous system and pulmonary disease using its patented dry powder inhalation iSPERSE™ technology, today announced fourth quarter and year-end financial results for 2023 and provided a corporate update on its development programs.
Ted Raad, Chief Executive Officer of Pulmatrix, commented, "Winding down the Phase 2b study for PUR1900, along with other cost-savings measures, is expected to extend Pulmatrix's cash runway into Q1 2026. We will continue our focus on strategic alternatives that leverage the potential of PUR3100, iSPERSE™ technology and our extended cash resources."
2023 and Recent Program and Corporate Highlights
PUR3100
The planned Phase 2 trial builds on the Phase 1 trial results, which were published in 2023 and presented at the American Headache Society 65th Annual Meeting in June 2023. Compared to observations of nausea and vomiting in the intravenously (IV) administered DHE dose group, the PUR3100 dose groups showed a lower incidence of nausea and no vomiting. 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) at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The results indicated PUR1800 was safe and well tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases. Pulmatrix plans to pursue partnership or other alternatives to monetize or advance PUR1800.
PUR1900
After the study wind down, Pulmatrix will bear no further financial responsibility for the development of PUR1900 and will receive 2% royalties on any potential future net sales by Cipla outside the United States. Within the United States, Pulmatrix and Cipla will seek to monetize PUR1900.
Fourth Quarter and Year-End Financial Results
Revenues increased $1.2 million to $7.3 million for the year ended December 31, 2023, compared to $6.1 million for the year ended December 31, 2022. The increase is related to higher activity under the Cipla Agreement for PUR1900 during the period.
Research and development expenses decreased approximately $2.7 million to $15.5 million for the year ended December 31, 2023, compared to $18.2 million for the year ended December 31, 2022. The decrease was primarily due to decreased spend of $2.7 million in costs related to the Company's PUR3100 program, $1.0 million of employment costs, and $0.7 million in costs related to the Company's PUR1800 program, partially offset by an increase of $1.3 million in costs related to the Company's PUR1900 program and $0.4 million of other operating costs.
General and administrative expenses decreased $0.3 million to $6.5 million for the year ended December 31, 2023, compared to $6.8 million for the year ended December 31, 2022. The decrease was primarily due to decreased spend of $0.7 million in employment costs, partially offset by an increase of $0.4 million in legal and professional services costs.
(PRNewsfoto/Pulmatrix, Inc.)
News provided by
Pulmatrix Inc.
28 Mar, 2024, 09:05 ET
Share this article
2023 year-end $19.2 million cash and cash equivalents provide projected cash runway into Q1 2026
3rd amendment to Cipla partnership resulted in the wind down of the PUR1900 Phase 2b study and a significant reduction in expected cash burn for Pulmatrix
Cipla to take sole responsibility for development of PUR1900, refocused on markets with greatest unmet need and faster path to approval, in exchange for 2% royalty on net sales payable to Pulmatrix
BEDFORD, Mass., March 28, 2024 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious central nervous system and pulmonary disease using its patented dry powder inhalation iSPERSE™ technology, today announced fourth quarter and year-end financial results for 2023 and provided a corporate update on its development programs.
Ted Raad, Chief Executive Officer of Pulmatrix, commented, "Winding down the Phase 2b study for PUR1900, along with other cost-savings measures, is expected to extend Pulmatrix's cash runway into Q1 2026. We will continue our focus on strategic alternatives that leverage the potential of PUR3100, iSPERSE™ technology and our extended cash resources."
2023 and Recent Program and Corporate Highlights
PUR3100
In September 2023, Pulmatrix announced the FDA's acceptance of an IND application for PUR3100 and receipt of a "study may proceed" letter for a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100, an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™, will be investigated in patients with acute migraine.
PUR1800
In February 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The results indicated PUR1800 was safe and well tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases. Pulmatrix plans to pursue partnership or other alternatives to monetize or advance PUR1800.
PUR1900
On January 8, 2024, in agreement with its partner Cipla, Pulmatrix announced plans to stop patient enrollment at 8 subjects in the Phase 2b study of PUR1900, effective immediately. PUR1900 is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. The decision to stop the study was unrelated to any safety concerns. This study had been ongoing since the first quarter of 2023. The Company expects to complete all Phase 2b activities by the third quarter of 2024.
Fourth Quarter and Year-End Financial Results
Revenues increased $1.2 million to $7.3 million for the year ended December 31, 2023, compared to $6.1 million for the year ended December 31, 2022. The increase is related to higher activity under the Cipla Agreement for PUR1900 during the period.
Research and development expenses decreased approximately $2.7 million to $15.5 million for the year ended December 31, 2023, compared to $18.2 million for the year ended December 31, 2022. The decrease was primarily due to decreased spend of $2.7 million in costs related to the Company's PUR3100 program, $1.0 million of employment costs, and $0.7 million in costs related to the Company's PUR1800 program, partially offset by an increase of $1.3 million in costs related to the Company's PUR1900 program and $0.4 million of other operating costs.
General and administrative expenses decreased $0.3 million to $6.5 million for the year ended December 31, 2023, compared to $6.8 million for the year ended December 31, 2022. The decrease was primarily due to decreased spend of $0.7 million in employment costs, partially offset by an increase of $0.4 million in legal and professional services costs.
The Company's total cash and cash equivalents balance as of December 31, 2023, was $19.2 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 2026.