Aspergillosis, Allergic Bronchopulmonary

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 Pulmatrix to significantly reduce cash burn and focus on strategic alternatives that leverage the company's promising pipeline, iSPERSE™ technology and approximately $19 million cash on hand as of 12/31/23 BEDFORD, Mass., Jan. 8, 2024 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system diseases, today announced that it has entered into a further amendment to its agreement with Cipla for the development of PUR1900 in the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA). Under the terms of the amendment Cipla and Pulmatrix agreed, among other things, to stop patient enrollment of the Ph2b study of PUR1900 at 8 subjects and close the study. Ted Raad, Chief Executive Officer of Pulmatrix, commented, "Stopping the Ph2b study, along with other cost-savings measures, is expected to extend Pulmatrix's cash runway into Q1 2026. As of December 31, 2023, Pulmatrix cash on hand was approximately nineteen million dollars. Pulmatrix focus will be on maximizing shareholder value by pursuing strategic alternatives for the company while it winds down the Ph2b study for PUR1900. We are confident in Cipla's ability to develop PUR1900 for the benefit of patients in markets where there is significant unmet need and a faster path to commercialization." Pursuant to the amended agreement with Cipla, Pulmatrix has granted Cipla exclusive rights to the development and commercialization of PUR1900 in the "Cipla Territory", which has been expanded to include all markets other than the United States. In the United States, both parties will seek to monetize PUR1900 which has potential for development in areas other than ABPA in Asthma. After the study winddown, Pulmatrix will bear no further financial responsibility for the development of PUR1900 and will receive 2% royalties on net sales of Pulmazole in the Cipla Territory. For more information about the amendment please refer to Pulmatrix's Current Report on Form 8-K to be filed with U.S. Securities and Exchange Commission on or around the date of this press release. Pulmatrix has retained MTS Health Partners, L.P. (MTS) as its financial advisor to support the company's Board of Directors and management team to review and evaluate strategic alternatives intended to maximize long-term value for all stockholders. About PUR3100 PUR3100 is an orally inhaled formulation of dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine. The Phase 1 PUR3100 trial results were presented at the 65th Annual Meeting of the American Headache society in June 2023. The PUR3100 IND for a Phase 2 trial was accepted by the FDA in September 2023. About PUR1800 PUR1800 is an orally inhaled formulation of RV1162, a narrow-spectrum kinase inhibitor with p38, Syc and Src kinase activity. PUR1800 is being developed for the treatment of acute exacerbations in Chronic Obstructive Pulmonary Disease. The Phase 1 PUR1800 trial results were presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology in February 2023. About iSPERSE™ Technology Our innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases. About Pulmatrix, Inc. Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases and central nervous system ("CNS") disorders using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for lung diseases, such as allergic bronchopulmonary aspergillosis ("ABPA"), Chronic Obstructive Pulmonary Disease ("COPD") and CNS disorders such as acute migraine. Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes. For more on our inhaled product candidates please visit: . Forward-Looking Statements Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by, and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the impact of the novel coronavirus (COVID-19) on the Company's ongoing and planned clinical trials; realizing the expected cost savings from closing the Ph2b study of PUR1900, the ability to identify and consummate strategic alternatives for the Company, our ability to preserve and allocate our cash on-hand most efficiently, the geographic, social and economic impact of COVID-19 on the Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Timothy McCarthy, CFA 917-679-9282 [email protected] SOURCE Pulmatrix Inc.

LONDON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Pulmocide Ltd., (“the Company”) a late-stage biopharmaceutical company developing opelconazole for patients suffering from serious acute and chronic respiratory diseases, today announced that Dan Burgess, Chairman and CEO, will present a corporate update at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024 from 5:00pm – 5:25pm PT in San Francisco. About OpelconazolePulmocide’s investigational product, opelconazole, is a potent novel azole therapy specifically designed for inhaled use to maximize the amount of drug in the lung while providing minimal systemic exposure. This profile is anticipated to enhance efficacy with a low risk for adding to the toxicities and drug-drug interactions seen with systemic antifungal therapies. Under the United Kingdom’s Special Needs provision, opelconazole was found to be generally well tolerated and demonstrated remarkable clinical responses. In this program, patients with a variety of different clinical profiles who had failed previous antifungal treatment options responded well when opelconazole was added to their treatment regimen. Opelconazole has the potential to be useful in a variety of conditions where Aspergillus has been implicated, including chronic pulmonary aspergillosis, cystic fibrosis, severe asthma, allergic bronchopulmonary aspergillosis, chronic pulmonary obstructive disease, severe flu, and post-COVID-19-associated lung damage. A late-stage clinical program has been initiated to support registration in patients who have failed prior therapy for invasive pulmonary aspergillosis (IPA). The safety and efficacy of opelconazole is currently under evaluation in a Phase 3 clinical trial in patients with refractory IPA. Enrollment in a Phase 2 prophylaxis safety study in lung transplant recipients was recently completed with data expected in the first quarter of 2024. About Pulmonary AspergillosisThe incidence of pulmonary fungal disease has increased substantially over the past two decades with Aspergillus species being the most common pathogen.1 Invasive pulmonary aspergillosis is associated with high morbidity and mortality rates in immuno-compromised patients including those undergoing hematological stem cell or solid organ transplantation (particularly lung transplants) and some patients in critical care, including those with COVID-19 or influenza-associated pulmonary aspergillosis.2 Aspergillus infection also plays an important role in severe asthma and cystic fibrosis and has been correlated with poorer clinical outcomes in patients with chronic obstructive pulmonary disease.2 Chronic lung infections with Aspergillus can leave patients with extensive and permanent lung damage, requiring a lifetime of antifungal treatment.2 About PulmocidePulmocide Ltd (www.pulmocide.com) is a late-stage biopharmaceutical company focused on the development of a novel inhaled azole therapy for patients at risk of developing serious complications associated with aspergillosis, such as immunocompromised patients and those with severe pulmonary diseases. The company is currently focused on acute and chronic treatments for pulmonary aspergillosis and its lead product opelconazole is being developed initially for the treatment of invasive pulmonary aspergillosis. References Where Aspergillosis Comes From, Centers for Disease Control and Prevention, accessed 12 October 2023Kousha M. et al: Pulmonary aspergillosis: a clinical review. Eur Respir Rev, 2011; 20(212):156-174 For further information, please contact: Pulmocide Contact:Jennifer Giottonini CayerChief Business Officer and Head of Corporate DevelopmentPulmocide Ltdjennifer@pulmocide.com Media Contact:Michael TattoryLifeSci Communications mtattory@lifescicomms.com

DUBLIN , Nov. 20, 2023 /PRNewswire/ -- The "Dupilumab Emerging Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering. This report offers comprehensive insights into the use of dupilumab for bullous pemphigoid across the seven major markets. It presents a detailed overview of dupilumab's application for bullous pemphigoid in the 7MM, encompassing the United States, EU4 (consisting of Germany, France, Italy, and Spain), the United Kingdom, and Japan, during the period from 2019 to 2032. The report includes an extensive description of the use of dupilumab for bullous pemphigoid. Dupilumab, marketed as Dupixent, is a monoclonal antibody designed to target the a-chain of the interleukin (IL)-4 receptor. Its primary function is to inhibit the biological effects of cytokines IL-4 and IL-13, both of which play pivotal roles in the TH2 response (Sastre, 2018). Dupilumab has received approval in the United States for several indications, including the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged 12 years and older who do not respond well to topical prescription therapies or are unable to use them. It is also approved for use in conjunction with other asthma medications to maintain the treatment of moderate-to-severe eosinophilic asthma or asthma dependent on oral steroids in patients aged 12 years and older whose asthma remains uncontrolled with current treatments. Additionally, it is approved for use in combination with other medications for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults with uncontrolled symptoms. For adolescents aged 12 and older, it is recommended that dupilumab be administered under the supervision of an adult. In addition to its existing approvals, Regeneron and Sanofi are actively researching the potential applications of dupilumab in various clinical development programs targeting diseases driven by allergic and Type 2 inflammation. These include conditions like peanut allergy, grass allergy, pediatric AD, pediatric asthma, eosinophilic esophagitis, chronic obstructive pulmonary disease (COPD), bullous pemphigoid (BP), prurigo nodularis, chronic spontaneous urticaria, and allergic bronchopulmonary aspergillosis. The report provides insights into the mechanism of action, recommended dosage and administration, research and development progress, and regulatory milestones, as well as other ongoing developmental activities. Furthermore, it offers future market assessments, including a forecast analysis of the dupilumab market for bullous pemphigoid in the 7MM, SWOT analysis, perspectives from analysts, a comprehensive overview of market competitors, and a brief overview of emerging therapies for bullous pemphigoid. Dupilumab Analytical Perspective In-depth Dupilumab Market Assessment This report provides a detailed market assessment of dupilumab for bullous pemphigoid in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2023 to 2032. Dupilumab Clinical Assessment The report provides the clinical trials information of dupilumab for bullous pemphigoid covering trial interventions, trial conditions, trial status, start and completion dates. Report Highlights In the coming years, the market scenario for bullous pemphigoid is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence dupilumab dominance. Other emerging products for bullous pemphigoid are expected to give tough market competition to dupilumab and launch of late-stage emerging therapies in the near future will significantly impact the market. A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of dupilumab in bullous pemphigoid. This in-depth analysis of the forecasted sales data of dupilumab from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the dupilumab in bullous pemphigoid. Scope of the Report A comprehensive product overview including the dupilumab description, mechanism of action, dosage and administration, research and development activities in bullous pemphigoid. Elaborated details on dupilumab regulatory milestones and other development activities have been provided in this report. The report also highlights the dupilumab research and development activities in bullous pemphigoid across the United States, Europe and Japan. The report also covers the patents information with expiry timeline around dupilumab. The report contains forecasted sales of dupilumab for bullous pemphigoid till 2032. Comprehensive coverage of the late-stage emerging therapies for bullous pemphigoid. The report also features the SWOT analysis with analyst views for dupilumab in bullous pemphigoid. Key Topics Covered: 1. Report Introduction 2. Dupilumab Overview in bullous pemphigoid 2.1. Product Detail 2.2. Clinical Development 2.2.1. Clinical studies 2.2.2. Clinical trials information 2.2.3. Safety and efficacy 2.3. Other Developmental Activities 2.4. Product Profile 3. Competitive Landscape (Marketed Therapies) 4. Competitive Landscape (Late-stage Emerging Therapies) 5. Dupilumab Market Assessment 5.1. Market Outlook of Dupilumab in bullous pemphigoid 5.2. 7MM Analysis 5.2.1. Market Size of Dupilumab in the 7MM for bullous pemphigoid 5.3. Country-wise Market Analysis 5.3.1. Market Size of Dupilumab in the United States for bullous pemphigoid 5.3.2. Market Size of Dupilumab in Germany for bullous pemphigoid 5.3.3. Market Size of Dupilumab in France for bullous pemphigoid 5.3.4. Market Size of Dupilumab in Italy for bullous pemphigoid 5.3.5. Market Size of Dupilumab in Spain for bullous pemphigoid 5.3.6. Market Size of Dupilumab in the United Kingdom for bullous pemphigoid 5.3.7. Market Size of Dupilumab in Japan for bullous pemphigoid 6. SWOT Analysis 7. Analysts' Views For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets