Aspergillosis, Allergic Bronchopulmonary

Completed series of transactions with MannKind Corporation validating iSPERSE™ technology and extending projected cash runway into Q4 2026 $12.4 million in cash and cash equivalents at the end of Q2 2024, with an additional $1.4 million in restricted cash becoming unrestricted in August 2024 Pursuing strategic alternatives to further leverage iSPERSE™ and optimize the potential of PUR3100 FRAMINGHAM, Mass., Aug. 13, 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 second quarter financial results for 2024 and provided a corporate update on its clinical assets. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the second quarter has been to continue our cost saving measures, to complete the transactions with MannKind and to continue the wind down of the Phase 2b study for PUR1900. We believe that this has allowed us to reposition ourselves as a virtual company while continuing to focus on strategic alternatives that leverage the potential of PUR3100 and our iSPERSE™ technology." Second Quarter 2024 and Recent Program and Corporate Highlights PUR3100 PUR3100 is an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine. Pulmatrix is currently exploring financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100. In 2023, Pulmatrix announced the FDA's acceptance of an IND application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study, positioning PUR3100 as Phase 2-ready. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 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's 65th Annual Meeting in June 2023. In May 2024, Pulmatrix announced a peer-reviewed publication of Phase 1 clinical results in the publication Headache: The Journal of Head and Face Pain. The study 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. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously (IV) administered DHE dose group. PUR1800 PUR1800 is a Narrow Spectrum Kinase Inhibitor, engineered with our iSPERSE™ technology, for the treatment of acute exacerbations in chronic obstructive pulmonary disease (AECOPD). In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for AECOPD, indicating 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 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. In agreement with its partner Cipla, Pulmatrix has stopped patient enrollment for the Phase 2b study of PUR1900. 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 remains on track to complete all Phase 2b wind down activities within 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. Second Quarter 2024 Financial Results Revenues decreased approximately $0.3 million to $1.6 million for the three months ended June 30, 2024, compared to $1.8 million for the three months ended June 30, 2023. The decrease is primarily related to the continued winding down of the PUR1900 Phase 2b clinical trial, for which the Company incurred fewer expenses eligible for reimbursement under its Agreement with Cipla as compared to the corresponding period in the previous year. Research and development expenses decreased approximately $1.3 million to $2.8 million for the three months ended June 30, 2024, compared to $4.2 million for the three months ended June 30, 2023. The decrease was primarily due to winding down the PUR1900 Phase 2b clinical trial. General and administrative expenses increased approximately $0.3 million to $2.0 million for the three months ended June 30, 2024, compared to $1.7 million for the three months ended June 30, 2023. The increase was primarily due to an increase in incurred legal costs. The company recognized a $2.6 million loss on its disposal group of held for sale assets as of June 30, 2024, representing the current period write-down for the fair value of certain assets to be transferred to MannKind Corporation in the third quarter of 2024. The Company's total cash and cash equivalents balance as of June 30, 2024, was $12.4 million plus $1.4 million in short-term restricted cash, which was released in August 2024, providing additional cash available to use in operations. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations into the fourth 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 central nervous system ("CNS"), respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for 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 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.

Cross license involves Pulmatrix iSPERSE™ technology and MannKind's Cricket® inhalation device. Pulmatrix transferring leased building, all leasehold improvements, laboratory equipment and other related personal property in exchange for MannKind assumption of lease. Master service agreement in place for MannKind to provide future iSPERSE™ dry powder drug formulation development services to Pulmatrix. BEDFORD, Mass., May 29, 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 diseases using its patented dry powder inhalation iSPERSE™ technology, today announced a series of transactions with MannKind Corporation (Nasdaq: MNKD). Ted Raad, Chief Executive Officer of Pulmatrix, commented, "MannKind's interest in iSPERSE™ validates the enablement potential of our innovative particle engineering dry powder technology. In addition, the assumption of our lease and laboratory by MannKind helps extend our cash runway further into 2026. We are able to build upon this agreement to further support development of PUR3100 and its potential application with MannKind's Cricket® device to develop the 1st orally inhaled DHE treatment for acute migraine." The Company entered into a cross license with MannKind pursuant to which MannKind will grant Pulmatrix a perpetual, royalty free, exclusive license to use MannKind's Cricket inhalation device for the inhaled delivery of PUR3100, our proprietary formulation of dihydroergotamine (DHE) with iSPERSE™, and a perpetual, royalty free, non-exclusive license to use MannKind's Cricket inhalation device for the inhaled delivery of any dry powder formulation formulated for the treatment or prevention of neurological disease. As part of the cross-license, the Company will grant MannKind a perpetual, royalty free, exclusive license to formulate iSPERSE™ with clofazimine for inhalation by humans for the treatment or prevention of infection, for the treatment or prevention of nontuberculous mycobacteria lung disease in humans, and with insulin for inhalation by humans for the treatment or prevention of diabetes. We will also grant MannKind a perpetual, royalty free, non-exclusive license to formulate iSPERSE™ for inhalation for the treatment or prevention of endocrine disease and for inhalation for the treatment or prevention of interstitial lung diseases (including IPF, PPF and other related lung diseases) in humans (" ILD"). As part of the transaction, MannKind will assume the lease of our Bedford, Mass., R&D facility along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory. To maintain continuity of iSPERSE™ platform knowledge, MannKind plans to hire some members of the Pulmatrix R&D staff. The agreements are anticipated to close in July 2024. About Pulmatrix, Inc. Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat central nervous system ("CNS"), respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for 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: . 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. Over 38 million patients suffer from migraine in the United States and there is currently no orally inhaled DHE treatment option for patients. 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. 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 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.

Orally Inhaled PUR3100 is associated with rapid systemic PK within the therapeutic window and a mean time to Cmax matching intravenously (IV) administered DHE. Self-administered PUR3100 showed improved safety and tolerability relative to IV DHE. Pulmatrix previously received FDA's acceptance of an IND application and a "study may proceed" letter for a Phase 2 study, positioning PUR3100 as Phase 2-ready. BEDFORD, Mass., May 15, 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 diseases using its patented dry powder inhalation iSPERSE™ technology, today announced publication of, "Safety, tolerability, and pharmacokinetics of a single orally inhaled dose of PUR3100, a dry powder formulation of dihydroergotamine versus intravenous dihydroergotamine: A Phase 1 randomized, double-blind study in healthy adults" in the peer-reviewed publication Headache: The Journal of Head and Face Pain. Ted Raad, Chief Executive Officer of Pulmatrix, commented, "In this trial, PUR3100 demonstrated the potential for rapid pain relief and improved DHE tolerability versus IV DHE. With a Tmax of 5 minutes and a Cmax in the therapeutic window for all doses tested, we believe that PUR3100 has the potential to address an unmet need for acute migraine sufferers and we are pursuing different options to advance PUR3100 into a Phase 2 clinical trial to further investigate its promising profile in treating acute migraine." The completed Phase 1 study demonstrated optimal pharmacokinetics and improved tolerability of PUR3100 compared to IV DHE. The Phase 1 trial was a randomized, double-dummy, double-blinded design to assesses the safety, tolerability, and pharmacokinetics (PK) of three dose groups treated with inhaled PUR3100 with intravenous (IV) placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo in healthy volunteers. All doses of PUR3100 were generally well tolerated with a lower incidence of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%) compared to IV DHE. The PK profile of PUR3100 versus IV DHE was characterized by a similar mean time to Cmax (5 vs. 5.5 min), with reduced AUC0–2h (1120–4320 vs. 6340), and a lower Cmax (3620–14,400 vs. 45,000). All doses of PUR3100 were associated with mean Cmax above the minimum level required to achieve efficacy (1000 pg/mL). Please use this link to the early view on the journal, Headache: Pulmatrix is currently looking at opportunities to finance or partner PUR 3100 to initiate a potential Phase 2 clinical study. 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. Over 38 million patients suffer from migraine in the United States and there is currently no orally inhaled DHE treatment option for patients. 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 Headache Headache: The Journal of Head and Face Pain is a peer-reviewed medical journal covering all aspects of head and face pain. It is the official journal of the American Headache Society. It was established in 1961 and is published ten times per year. About Pulmatrix, Inc. Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat central nervous system ("CNS"), respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for 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 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.