Aspergillosis, Allergic Bronchopulmonary

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. 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 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. 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. 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. About Pulmatrix, Inc. Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for central nervous system ("CNS") disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease ("COPD") and allergic bronchopulmonary aspergillosis ("ABPA"). 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 the Company's 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) endemic on the Company's ongoing and planned clinical trials; 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 tim@lifesciadvisors.com Company Codes: NASDAQ-NMS:PULM

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