|Over a week ago|
Pulmatrix reports Q1 EPS (9c), one estimate (10c) » 16:3705/1105/11/21
Reports Q1 revenue $1.4M,…
Reports Q1 revenue $1.4M, one estimate $0. As of March 31 Pulmatrix had $63.4M in cash and cash equivalents, compared to $31.7M for the year ended December 31, 2020. "The Q1 has marked a number of significant milestones for Pulmatrix," said Ted Raad, CEO of Pulmatrix. "Each of our iSPERSE enabled programs, ranging from asthma, COPD, and migraine, represents an opportunity to address significant unmet needs of large patient populations. We are pleased to now have the kinase inhibitor portfolio back in our proprietary pipeline following the termination of the development and licensing agreement with Johnson & Johnson. We also remain steadfast in our objective to bring Pulmazole to market and address significant unmet need of patients suffering from ABPA. Our recent notice to Cipla Technologies demonstrates that commitment. With our strong balance sheet, we believe that we can fund operations through planned data milestones for PUR1800 and PUR3100 and, if we ultimately re-acquire Pulmazole from Cipla, begin our Ph2b study."
Pulmatrix to host conference call » 09:2504/2304/23/21
10 am. Pulmatrix…
Pulmatrix to host conference call » 04:5504/2304/23/21
10 am. Pulmatrix…
|Over a month ago|
Pulmatrix to host conference call » 14:4504/1504/15/21
10 am. Pulmatrix…
Pulmatrix price target lowered to $5 from $10 at H.C. Wainwright » 06:1604/1304/13/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Andrew Fein lowered the firm's price target on Pulmatrix to $5 from $10 and keeps a Buy rating on the shares after learning of the termination of the license, development and commercialization agreement for the narrow spectrum kinase program with the Lung Cancer Initiative of Johnson & Johnson. This effectively returns narrow spectrum kinase Phase 1b candidate PUR1800 to Pulmatrix for continued development, Fein tells investors in a research note.
Pulmatrix to regain full rights to NSKI portfolio » 09:0804/1204/12/21
Pulmatrix (PULM announced…
Pulmatrix (PULM announced it will regain full rights to its narrow spectrum kinase inhibitor portfolio, including PUR1800, following Johnsons & Johnson's (JNJ) Enterprise Innovation's decision to terminate the company's license, development and commercialization agreement. Pulmatrix intends to continue the development of PUR1800, with ongoing clinical and toxicology studies to support programs in acute exacerbations in COPD and other chronic airway diseases. "Regaining full rights to PUR1800, and the broader portfolio of NSKIs, positions Pulmatrix to independently advance assets that have the potential to address multiple blockbuster markets," said Ted Raad, CEO of Pulmatrix. "Our prior agreement with Johnson & Johnson greatly advanced our PUR1800 program, fully funding both our ongoing Phase 1b study and ongoing long-term toxicology studies. With data from these studies expected before year end, we expect to be positioned to advance our planned Phase 2b study in AECOPD treatment, which has the potential for approximately $2.5 billion in U.S. peak net revenue potential. Importantly, our long-term toxicology studies also have the potential to broaden the reach of PUR1800 to indications beyond AECOPD that require long-term dosing. We look forward to continued progress with PUR1800 and believe our superior iSPERSE formulation has the opportunity to address steroid resistant and infection driven inflammation across a diverse range of lung conditions."
Pulmatrix provides pipeline and business update » 09:1903/0403/04/21
Pulmatrix provides an…
Pulmatrix provides an update on its business and product pipeline. On 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, shortly after data from 6 and 9 month toxicology studies. On Pulmazole: completed a Type C Meeting with the FDA for the further clinical development of Pulmazole, based on which Pulmatrix intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis in Q1 2022. On PUR3100: in a dog PK study, PUR3100, a dry powder iSPERSE formulation of DHE, demonstrated similar exposure kinetics to modelled kinetics from published data with MAP0004, the MAP Pharmaceuticals pMDI inhaled formulation of DHE. Pulmatrix believes iSPERSE mitigates the manufacturing / device issues which led to MAP0004 FDA complete response letters while enabling a similar pharmacokinetic profile. PUR3100 plans to advance into IND enabling toxicology studies with anticipated Ph1/Ph2 clinical study start in Q1 2022. The company completed a registered direct offering with gross proceeds of $40M extending the company's cash runway to fully fund data readouts across its development pipeline including PUR1800 Phase 1b, PUR3100 Phase 1 / Phase 2 and Pulmazole Phase 2b studies.
|Over a quarter ago|
Pulmatrix raises $40M in a registered direct offering » 05:0902/1102/11/21
Pulmatrix announced that…
Pulmatrix announced that it has entered into definitive agreements with healthcare-focused institutional investors for the purchase and sale of 20,000,000 shares of the Company's common stock, at a purchase price of $2.00 per share, in a registered direct offering priced at-the-market under Nasdaq rules. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
Pulmatrix announces commercial launch of FEND » 09:0210/2110/21/20
Pulmatrix announced marketing and distribution partner Sensory Cloud's commercial launch of FEND, a hypertonic calcium chloride salt solution with nasal mister. FEND is a potentially important new hygiene option beyond masks to combat the ongoing COVD-19 pandemic. Pulmatrix licensed the rights to the company's NasoCalm proprietary formulations (PUR003 and PUR006) to Sensory Cloud, now integral to the product FEND, with Sensory Cloud to market and distribute FEND, and Pulmatrix to receive escalating royalties, upon commencement of sales.
Pulmatrix's FEND solution shows reduction of exhaled bioaerosols in publication » 08:3609/3009/30/20
Pulmatrix Announces Publication Demonstrating Reduction of Bioaerosols with FEND, an OTC Nasal Hygiene Product Designed to Cleanse Airways of Airborne Particles FEND Administration Lowered Exhaled Particles in Subjects Including Healthy Subjects and a COVID-19 Patient Partner Sensory Cloud to Distribute FEND Worldwide, with Pulmatrix Receiving Escalating Royalties upon Commencement of Sales Pulmatrix announced the publication of data from partner Sensory Cloud detailing the utility of FEND, a hypertonic calcium chloride salt solution with nasal mister, in the reduction of bioaerosol generation in the airways. Pulmatrix licensed the rights to the company's NasoCalm proprietary formulations to Sensory Cloud, now integral to the product FEND, with Sensory Cloud to market and distribute FEND, and Pulmatrix to receive escalating royalties, upon commencement of sales. The publication in the journal Molecular Frontiers reports, among its key findings: in studies across adults and children, FEND nasal salt aerosols lowered exhaled particles by approximately 75% and outperformed surgical masks in the clearing of sub-micron particles; the majority of particles exhaled during natural breathing are smaller in size than current hygiene practices are designed to block; approximately 20% of subjects identified as Super Spreaders of airborne particles, account for 80% of the overall exhaled aerosols; FEND delivery suppressed exhaled aerosols 30 minutes post treatment by 78% overall for all non-Covid-19 Super Spreaders; FEND administration led to a similar reduction in bioaerosol production in a COVID-19 patient who appeared to develop with her infection an acute increase in bioaerosol production consistent with Super Spreader status.