PUR1800 / Pulmatrix - LARVOL DELTA

Ex-vivo Evaluation of the Potential for Narrow Spectrum Kinase Inhibitors as a Treatment for Idiopathic Pulmonary Fibrosis (ATS 2024) - "PCLS core samples in duplicate were treated with test compounds RV1162, RV7031, Nintedanib as a positive control or vehicle as a negative control. Similarly, RV7031 resulted in a dose-related reduction in IL-6 only. These data indicate that Narrow Spectrum Kinase Inhibitors in general, and RV1162 in particular, reduce endogenous pro-inflammatory cytokine production and IPF-related gene expression in lung tissue samples from IPF donors and accordingly may have potential for the treatment of IPF."

Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • IL6 • MMP9 • SYK

Pulmatrix Announces Third Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "PUR1900 (itraconazole, administered as a dry powder for inhalation using iSPERSE™) has been in a Phase 2 trial for the treatment of ABPA in patients with asthma (NCT05667662)....Pulmatrix currently anticipates topline data from this study in the second half of 2024....Pulmatrix plans to pursue partnership opportunities to advance PUR1800 into a potential Phase 2 clinical trial....Research and development expenses decreased approximately $1.3 million to $4.0 million for the three months ended September 30, 2023 compared to $5.3 million for the three months ended September 30, 2022. The decrease was primarily due to decreased spend of $0.7 million in costs related to the Company's PUR3100 program, $0.4 million in costs related to the Company's PUR1900 program, $0.1 million in costs related to the Company's PUR1800 program and $0.1 million of employment and operating costs."

Commercial • New P2 trial • P2 data • Allergic Bronchopulmonary Aspergillosis • Chronic Obstructive Pulmonary Disease

Pulmatrix Announces Second Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "PUR1900; PUR1900 is currently in a Phase 2 trial for the treatment of ABPA in patients with asthma....Pulmatrix anticipates topline data from this study in the third quarter of 2024....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."

Commercial • Allergic Bronchopulmonary Aspergillosis • Asthma • CNS Disorders • Infectious Disease • Migraine • Pain • Pulmonary Disease • Respiratory Diseases

Pulmatrix Announces First Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "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...$0.3 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."

Commercial • Allergic Bronchopulmonary Aspergillosis • Asthma • Chronic Obstructive Pulmonary Disease

SAFETY AND TOLERABILITY OF PUR1800, AN ORALLY INHALED NARROW SPECTRUM KINASE INHIBITOR, IN PATIENTS WITH STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). (AAAAI 2023) - "Inhaled PUR1800 was safe and well tolerated in stable COPD patients. Systemic exposure resulted in limited accumulation with steady state by 7 days. A proof-of-concept study with PUR1800 is warranted in patients with AECOPD"

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • SYK

Pulmatrix to Present Data on PUR1800 at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (PRNewswire) - "Pulmatrix...today announced the acceptance of an abstract for presentation at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting, to be held February 24-27, 2023 in San Antonio, Texas. The abstract will summarize the data from a recently completed Phase 1b study and will be presented by Margaret Wasilewski MD, Chief Medical Officer at Pulmatrix."

P1 data • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Pulmatrix Announces Third Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - "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....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....This amount was partially offset by a $1.0 million decrease in non-clinical and clinical costs related to the PUR1800 program."

Commercial • P1 data • Chronic Obstructive Pulmonary Disease

Pulmatrix Announces Second Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - "Second Quarter 2022 and Recent Program Highlights...PUR1800...Pulmatrix is analyzing data from the completed Phase 1b clinical study of PUR1800 for future publication and conducting further modeling to inform the Phase 2 study design....For the three months ended June 30, 2022, research and development expenses were $4.3 million compared to $4.5 million for the same period in 2021, a decrease of $0.2 million. The decrease was primarily due to decreased spending of $0.9 million in preclinical and clinical costs related to the PUR 1800 program and $0.5 million in preclinical and manufacturing costs related to the PUR 3100 program, partially offset by increased spending of $0.6 million in clinical and manufacturing costs related to the Pulmazole program, $0.5 million in employment costs and $0.1 million in facility costs."

Commercial • Idiopathic Pulmonary Fibrosis

A Phase 1b Study of PUR1800 in Patients With COPD (clinicaltrials.gov) - P1b | N=18 | Completed | Sponsor: Pulmatrix Inc. | Recruiting ➔ Completed | Trial completion date: Jul 2021 ➔ Dec 2021 | Trial primary completion date: Jul 2021 ➔ Dec 2021

Trial completion • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Pulmatrix Announces Positive Top-Line Data Evaluating PUR1800 in Patients with Stable COPD (PRNewswire) - P1b | N=15 | NCT04759807 | Sponsor: Pulmatrix Inc. | "Pulmatrix...today announced positive top-line results of its recently completed Phase 1b clinical study of PUR1800, a narrow-spectrum kinase inhibitor (NSKI) administered as a dry powder for inhalation with iSPERSE™ for evaluation in patients with stable Chronic Obstructive Pulmonary Disease (COPD)....Safety and tolerability as well as systemic PK were evaluated. PUR1800 was well-tolerated and there were no observed safety signals. The preliminary PK data indicate that PUR1800 results in low and consistent systemic exposure when administered via oral inhalation....'We will continue to evaluate the complete datasets and expect to submit study results at a relevant medical conference later this year.'"

P1 data • Chronic Obstructive Pulmonary Disease

Pulmatrix Reports Second Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - "Completed enrollment in ongoing Phase 1b clinical study of PUR1800 in acute exacerbations in COPD (AECOPD)....Top-line data is expected in Q1 2022: From 6-month rat...toxicology results demonstrate no progression of 28-day findings, suggesting potential for chronic dosing of PUR1800 in indications beyond AECOPD including, but not limited to, steroid resistant asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF)....Revenue for the second quarter of 2021 was $2.2 million, compared to $3.5 million for the same period in 2020. The revenue for the second quarter of 2021 was the result of the collaboration and licensing agreements with Cipla and JJEI. Research and development expense was $4.5 million in the second quarter of 2021...The increase year–over-year was primarily attributable to increased preclinical and manufacturing costs...decreased spend on the Pulmazole clinical trial."

Commercial • Enrollment closed • P1 data • Preclinical • Asthma • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis • Respiratory Diseases

Pulmatrix Reports First Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - "On May 10, 2021, we sent a letter to Cipla Technologies LLC ('Cipla') notifying Cipla that it is in material breach of our Development and Commercialization Agreement (the 'Cipla Agreement'), dated April 15, 2019, due to Cipla's anticipatory breach of its obligation under the Cipla Agreement to fund 50% of the development costs for Pulmazole...Pulmatrix intends to advance Pulmazole clinically to Ph2b....Research and development expense was $3.9 million in the first quarter of 2021 compared to $5.3 million for the same period in 2020. The decrease year–over-year was primarily attributable to decreased costs associated with the PUR1800 program and clinical study costs incurred for the Phase 2 Pulmazole study..."

Commercial • Licensing / partnership • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Pulmatrix Will Regain Full Rights To PUR1800 After Termination Of Licensing Agreement; Shares Fall 16% (Nasdaq) - "Pulmatrix is poised to regain full rights to its narrow spectrum kinase inhibitor (NSKI), including PUR1800. Johnson & Johnson Enterprise Innovation, a subsidiary of Johnson & Johnson, terminated Pulmatrix's license, development and commercialization agreement sending Pulmatrix shares down 16%. Pulmatrix (PULM) intends to continue developing PUR1800 and according to Chief Executive Officer, Ted Raad, regaining full rights should allow the company to advance assets that can address blockbuster markets."

Licensing / partnership • Stock price • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Corrected: Pulmatrix to Regain Full Rights to PUR1800 and Narrow Spectrum Kinase Inhibitor Portfolio (PRNewswire) - "Pulmatrix, Inc....announced it will regain full rights to its narrow spectrum kinase inhibitor (NSKI) portfolio, including PUR1800, following Johnsons & Johnson's Enterprise Innovation's decision to terminate the Company's license, development and commercialization agreement. Pulmatrix intends to continue the development of PUR1800...Dosing in the ongoing Phase 1b clinical study of PUR1800 in AECOPD is ongoing....Pulmatrix plans to initiate a PUR1800 Phase 2 proof-of-concept efficacy study for the treatment of AECOPD in 2022....'With data from these studies expected before year end, we expect to be positioned to advance our planned Phase 2b study in AECOPD treatment'..."

Licensing / partnership • New P2 trial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

"$PULM Corrected: Pulmatrix to Regain Full Rights to PUR1800 and Narrow Spectrum Kinase Inhibitor Portfolio https://t.co/dJMaXshFWv" (@stock_titan)

Pulmatrix Reports 2020 Financial Results and Provides Business Update (PRNewswire) - "PUR1800: Initiated the Phase 1b clinical study of PUR1800, dosing 4 of 15 patients to date....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."

Trial initiation date • Trial status • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Pulmatrix Provides a Pipeline and Business Update (PRNewswire) - "PUR1800: 3 of 15 patients have been dosed in the Phase 1b clinical study with endpoints including 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....Completed a registered direct offering with gross proceeds of $40 million extending the Company's cash runway to fully fund data readouts across its development pipeline including PUR1800 Phase 1b..."

P1 data • Trial status • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

A Phase 1b Study of PUR1800 in Patients With COPD (clinicaltrials.gov) - P1b; N=15; Recruiting; Sponsor: Pulmatrix Inc.

Clinical • New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Pulmatrix Reports Third Quarter 2020 Financial Results and Business Updates (PRNewswire) - "Pulmatrix anticipates initiating its Phase 1b study evaluating PUR1800, its iSPERSE enabled narrow spectrum kinase inhibitor (NSKI), in patients with stable COPD in the first half of 2021...Net loss was $10.6 million for the third quarter of 2020 and $3.6 million for the third quarter of 2019. The net loss for the third quarter 2020 was primarily due to warrant inducement expense of $9.3 million and manufacturing costs for the upcoming PUR1800 Phase 1b clinical study and the recently terminated Pulmazole Phase 2 study. The net loss for the third quarter of 2019 was due to spend on the Pulmazole Phase 2 study."

Commercial • New P1 trial • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases