PULM
PulmatrixDDocument history
Earnings documents stored for PULM.
Investor releaseQuarter not tagged2026-08-13Pulmatrix Announces Second Quarter 2026 Financial Results and Progress on Merger
PR Newswire
Pulmatrix Announces Second Quarter 2026 Financial Results and Progress on Merger
Form S-4 filed related to the announced merger agreement with Eos SENOLYTIX FRAMINGHAM, Mass., Aug. 13, 2026 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced its second quarter financial results for 2026 and provided a corporate update related to the merger agreement with Eos SENOLYTIX announced at the end of the first quarter of 2026. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the second quarter and beyond has been to advance steps towards completing the proposed merger with Eos SENOLYTIX, a privately held biotechnology company developing novel gerotherapeutic peptides targeting mitochondrial dysfunction in aging-related diseases using the MitoXcel™ platform. To that end, we have filed a Form S-4 in relation to the Merger." Proposed Merger with Eos SENOLYTIX As previously reported, on March 26, 2026, the Company entered into an agreement (the "Merger Agreement") and plan of merger (the "Merger") with Eos SENOLYTIX, Inc. ("Eos"). The proposed Merger is currently anticipated to close in the third quarter of 2026, subject to customary closing conditions. If the proposed Merger is completed, the business of Eos will continue as the business of the combined company. In connection with the entry into the Merger Agreement, on March 26, 2026, the Company announced that it entered into a securities purchase agreement with an affiliate of Eos for the issuance and sale in a private placement of its newly designated Series B Convertible Preferred Stock, raising aggregate gross proceeds of $1.0 million. Additional information about the Merger Agreement was previously disclosed in a registration statement on Form S-4 (File No. 333-297342) initially filed with the Securities and Exchange Commission (the "SEC") on July 9, 2026, as amended on August 3, 2026. Pulmatrix Seeks to Out-license or Monetize its Clinical Assets iSPERSE™ Technology iSPERSE™, also licensed to MannKind Corporation and Cipla Technologies for certain fields of use, utilizes particles that are engineered with a small, dense and dispersible profile to exceed the performance of tradi…Read full documentShow less
Form S-4 filed related to the announced merger agreement with Eos SENOLYTIX FRAMINGHAM, Mass., Aug. 13, 2026 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced its second quarter financial results for 2026 and provided a corporate update related to the merger agreement with Eos SENOLYTIX announced at the end of the first quarter of 2026. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the second quarter and beyond has been to advance steps towards completing the proposed merger with Eos SENOLYTIX, a privately held biotechnology company developing novel gerotherapeutic peptides targeting mitochondrial dysfunction in aging-related diseases using the MitoXcel™ platform. To that end, we have filed a Form S-4 in relation to the Merger." Proposed Merger with Eos SENOLYTIX As previously reported, on March 26, 2026, the Company entered into an agreement (the "Merger Agreement") and plan of merger (the "Merger") with Eos SENOLYTIX, Inc. ("Eos"). The proposed Merger is currently anticipated to close in the third quarter of 2026, subject to customary closing conditions. If the proposed Merger is completed, the business of Eos will continue as the business of the combined company. In connection with the entry into the Merger Agreement, on March 26, 2026, the Company announced that it entered into a securities purchase agreement with an affiliate of Eos for the issuance and sale in a private placement of its newly designated Series B Convertible Preferred Stock, raising aggregate gross proceeds of $1.0 million. Additional information about the Merger Agreement was previously disclosed in a registration statement on Form S-4 (File No. 333-297342) initially filed with the Securities and Exchange Commission (the "SEC") on July 9, 2026, as amended on August 3, 2026. Pulmatrix Seeks to Out-license or Monetize its Clinical Assets iSPERSE™ Technology iSPERSE™, also licensed to MannKind Corporation and Cipla Technologies for certain fields of use, utilizes particles that are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases. As of June 30, 2026, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 142 granted patents, 17 of which are U.S.-granted patents, plus approximately 49 pending patent applications in the U.S. and other jurisdictions. In July 2026, Pulmatrix was awarded a patent in India with claims encompassing PUR1900 resulting from a patent hearing in India. PUR1900 PUR1900, has been approved to proceed to a Phase 3 in India conducted by our partner Cipla. This is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole being investigated for various indications. The Company and its partner, Cipla, wound down a Phase 2b trial that the Company was operating in 2024. Cipla has continued clinical development outside the United States, and in 2025 completed their Phase 2 study in India, published positive results and has been approved by India's Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial, which Cipla currently expects to commence in 2026. Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States should Cipla successfully market PUR1900 outside the United States. Within the United States, the Company and Cipla share the rights 50/50 and will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. PUR3100 PUR3100, a Phase 2-ready asset, is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE™ dry powder inhalation technology for the treatment of acute migraine has a Food and Drug Administration acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in the peer-reviewed 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 ("NSKI"), 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 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. In 2024, Pulmatrix published an abstract titled "Ex vivo evaluation of the potential for Narrow Spectrum Kinase inhibitors as a treatment for Idiopathic Pulmonary Fibrosis". Second Quarter 2026 Financial Results Research and development expenses were less than $0.1 million for both the three months ended June 30, 2026, and 2025. All clinical development is currently on hold while the Company works to license or monetize our clinical assets. General and administrative expenses decreased approximately $0.5 million to $1.0 million for the three months ended June 30, 2026, compared to $1.5 million for the three months ended June 30, 2025. The decrease was primarily due to lower costs incurred related to software subscriptions, legal and patent costs, and business development and merger-related activities. The Company's total cash and cash equivalents balance as of June 30, 2026, was $2.2 million, in addition to $0.7 million in restricted cash that would become unrestricted following consummation of the Merger, as compared to $4.1 million as of December 31, 2025. The Company's unaudited financial statements were prepared assuming that the Company will continue as a going concern within one year after the date such financial statements are issued. The Company anticipates that its cash position, based on current operational efficiencies and prioritization of spending, is sufficient to fund its operations at least through the anticipated closing of the proposed Merger with Eos. About Pulmatrix, Inc.Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory 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 optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes. For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html. About Eos SENOLYTIX, Inc.Eos SENOLYTIX is a biotechnology company focused on developing first-in-class gerotherapeutic peptide medicines that target the underlying biological mechanisms of aging. Eos's lead clinical candidates, PTC-2105 and PTC-2107, both proprietary MitoXcel™ geropeptides, have demonstrated the ability to rejuvenate naturally aged mice via two separate mechanisms, both via a single, aging-specific target, the mitochondrial membrane potential (MMP), also called the "Δψm". These two mechanisms include (1) the return of the efficiency of mitochondrial. Merger-associated financings are expected to support advancement of the combined company's pipeline through key clinical milestones. Eos is led by Kevin Slawin, M.D., Founder and Chief Executive Officer, a physician-scientist and serial biotechnology entrepreneur with decades of experience in translational medicine, drug development, and company formation. Dr. Slawin was the founder of Bellicum Pharmaceuticals, Inc., an early pioneer in CAR T cell therapies, and has founded and is currently leading multiple life sciences ventures focused on aging biology and mitochondrial therapeutics. He is supported by a team of experienced biotechnology executives, scientists, and advisors with prior leadership roles at major pharmaceutical companies, academic medical centers, and emerging biotechnology firms. For more information, visit https://www.eossenolytix.com. Forward-Looking StatementsCertain 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 and include, but are not limited to, the use of proceeds from the private placement and conversion of the Series B Preferred Stock. 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 consummation of any other potential reverse merger transaction in the future, among others; the Company's ability to divest its clinical assets on terms favorable to the Company, or at all, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market; the Company's ability to continue as a going concern, 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, including the proposed Merger with Cullgen, 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:Chuck PadalaManaging DirectorLifeSci [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-announces-second-quarter-2026-financial-results-and-progress-on-merger-302850250.html
Investor releaseQuarter not tagged2026-05-15Pulmatrix Announces First Quarter 2026 Financial Results
PR Newswire
Pulmatrix Announces First Quarter 2026 Financial Results
Announced merger agreement with Eos SENOLYTIX in March Closed private placement of preferred stock FRAMINGHAM, Mass., May 15, 2026 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced its first quarter financial results for 2026 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the first quarter was on our work to secure a strategic transaction for our company and our shareholders. We are pleased to report that on March 26th we announced entering into a merger agreement with Eos SENOLYTIX, a privately held biotechnology company developing novel gerotherapeutic peptides targeting mitochondrial dysfunction in aging-related diseases using its proprietary MitoXcel™ platform. We also secured aggregate gross proceeds of $1 million from a private placement of preferred stock from an affiliate of Eos. Separate from the preferred stock, our common stockholders will receive approximately 6% interest in the new combined company without dilution from the preferred stock." Proposed Merger with Eos SENOLYTIX As previously reported, on March 26, 2026, the Company entered into an agreement (the "Merger Agreement") and plan of merger (the "Merger") with Eos SENOLYTIX, Inc. ("Eos"). The proposed Merger is anticipated to close in the third quarter of 2026, subject to customary closing conditions. If the proposed Merger is completed, the business of Eos will continue as the business of the combined company. In connection with the entry into the Merger Agreement, on March 26, 2026, the Company announced that it entered into a securities purchase agreement with an affiliate of Eos for the issuance and sale in a private placement of its newly designated Series B Convertible Preferred Stock, raising aggregate gross proceeds of $1.0 million. Additional information about the Merger Agreement was previously disclosed on a Current Report on Form 8-K filed with the SEC on March 27, 2026. Pulmatrix Seeks to Out-license or Monetize its Clinical Assets iSPERSE™ Technology iSPERSE™, also licensed to MannKind Corporation and Cipla Technologies for…Read full documentShow less
Announced merger agreement with Eos SENOLYTIX in March Closed private placement of preferred stock FRAMINGHAM, Mass., May 15, 2026 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced its first quarter financial results for 2026 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the first quarter was on our work to secure a strategic transaction for our company and our shareholders. We are pleased to report that on March 26th we announced entering into a merger agreement with Eos SENOLYTIX, a privately held biotechnology company developing novel gerotherapeutic peptides targeting mitochondrial dysfunction in aging-related diseases using its proprietary MitoXcel™ platform. We also secured aggregate gross proceeds of $1 million from a private placement of preferred stock from an affiliate of Eos. Separate from the preferred stock, our common stockholders will receive approximately 6% interest in the new combined company without dilution from the preferred stock." Proposed Merger with Eos SENOLYTIX As previously reported, on March 26, 2026, the Company entered into an agreement (the "Merger Agreement") and plan of merger (the "Merger") with Eos SENOLYTIX, Inc. ("Eos"). The proposed Merger is anticipated to close in the third quarter of 2026, subject to customary closing conditions. If the proposed Merger is completed, the business of Eos will continue as the business of the combined company. In connection with the entry into the Merger Agreement, on March 26, 2026, the Company announced that it entered into a securities purchase agreement with an affiliate of Eos for the issuance and sale in a private placement of its newly designated Series B Convertible Preferred Stock, raising aggregate gross proceeds of $1.0 million. Additional information about the Merger Agreement was previously disclosed on a Current Report on Form 8-K filed with the SEC on March 27, 2026. Pulmatrix Seeks to Out-license or Monetize its Clinical Assets iSPERSE™ Technology iSPERSE™, also licensed to MannKind Corporation and Cipla Technologies for certain fields of use, utilizes particles that are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases. As of March 31, 2026, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 146 granted patents, 18 of which are U.S.-granted patents, plus approximately 48 pending patent applications in the U.S. and other jurisdictions. PUR1900 PUR1900, has been approved to proceed to a Phase 3 in India conducted by our partner Cipla. This is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole being investigated for various indications. The Company and its partner, Cipla, wound down a Phase 2b trial that the Company was operating in 2024. Cipla has continued clinical development outside the United States, and in 2025 completed their Phase 2 study in India, published positive results and has been approved by India's Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial, which Cipla currently expects to commence in 2026. Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States should Cipla successfully market PUR1900 outside the United States. Within the United States, the Company and Cipla share the rights 50/50 and will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. PUR3100 PUR3100, a Phase 2-ready asset, is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE™ dry powder inhalation technology for the treatment of acute migraine has a Food and Drug Administration acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in the peer-reviewed 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 ("NSKI"), 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 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. In 2024, Pulmatrix published an abstract titled "Ex vivo evaluation of the potential for Narrow Spectrum Kinase inhibitors as a treatment for Idiopathic Pulmonary Fibrosis". First Quarter 2026 Financial Results Research and development expenses were less than $0.1 million for both the three months ended March 31, 2026, and 2025. All clinical development is currently on hold while the Company works to license or monetize our clinical assets. General and administrative expenses decreased approximately $0.5 million to $1.3 million for the three months ended March 31, 2026, compared to $1.8 million for the three months ended March 31, 2025. The decrease was primarily due to higher costs incurred in the three months ended March 31, 2025, related to the preparation and filing of a registration statement on Form S-4 and amendments thereto with the SEC. The Company's total cash and cash equivalents balance as of March 31, 2026, was $3.3 million, compared to $4.1 million as of December 31, 2025. The Company's unaudited financial statements were prepared assuming that the Company will continue as a going concern within one year after the date such financial statements are issued. The Company anticipates that its cash position, based on current operational efficiencies and prioritization of spending, is sufficient to fund its operations at least through the anticipated closing of the proposed Merger with Eos. About Pulmatrix, Inc. Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory 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 optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes. For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html. About Eos SENOLYTIX, Inc. Eos SENOLYTIX is a biotechnology company focused on developing first-in-class gerotherapeutic peptide medicines that target the underlying biological mechanisms of aging. Eos's lead clinical candidates, PTC-2105 and PTC-2107, both proprietary MitoXcel™ geropeptides, have demonstrated the ability to rejuvenate naturally aged mice via two separate mechanisms, both via a single, aging-specific target, the mitochondrial membrane potential (MMP), also called the "Δψm". These two mechanisms include (1) the return of the efficiency of mitochondrial function in aging cells almost immediately back to their younger, more efficient phenotype, and (2) the profound elimination of senescent cells throughout every organ in the body, including the brain, reducing their negative systemic inflammatory effects. Extensive preclinical studies suggest the MitoXcel™ platform may be a broad gerotherapeutic that improves body composition, increasing lean muscle mass, and enhancing physical function in aging animals. By targeting fundamental processes driving aging and aging-related diseases, Eos SENOLYTIX is pursuing a unique therapeutic opportunity to intervene in the aging process in ways that were once thought impossible. Eos SENOLYTIX is headquartered in Houston, Texas and operates within the broader SENOTHERAPEUTIX / GEROTHERAPEUTIX group of longevity companies, which focuses on developing therapeutics targeting fundamental drivers of aging to improve healthspan and lifespan. For more information, visit https://www.eossenolytix.com. 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 and include, but are not limited to, the use of proceeds from the private placement and conversion of the Series B Preferred Stock. 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 consummation of any other potential reverse merger transaction in the future, among others; the Company's ability to divest its clinical assets on terms favorable to the Company, or at all, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market; the Company's ability to continue as a going concern, 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, including the proposed Merger with Cullgen, 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: Chuck Padala Managing Director LifeSci Advisors 646-627-8390 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-announces-first-quarter-2026-financial-results-302773027.html
Investor releaseQuarter not tagged2026-02-26Pulmatrix Announces Year-End and Fourth Quarter 2025 Financial Results
PR Newswire
Pulmatrix Announces Year-End and Fourth Quarter 2025 Financial Results
Plans to License or Monetize our Migraine and Inhalation Assets Continue FRAMINGHAM, Mass., Feb. 26, 2026 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced year-end and fourth quarter financial results for 2025 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the fourth quarter was to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies for the treatment of pain, cancer and other diseases. We continue to work with Cullgen for approval from the China Securities Regulatory Commission, or CSRC, one of the closing conditions of the Merger. Pulmatrix and Cullgen agreed to waive the "No Solicitation" clause in the Merger Agreement to permit each party to explore transactions that may benefit our respective companies while still seeking approval from the CSRC. In conjunction with the proposed merger, Pulmatrix is currently in a process to license or partner its patent portfolio encompassing our iSPERSE™ technology, as well as three related clinical programs, including our Phase 2 ready acute migraine program. Proposed Merger with Cullgen As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger"). If the proposed Merger is completed, the business of Cullgen will continue as the business of the combined company. Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025, and declared effective on May 9, 2025. On June 16, 2025, the Company held a special meeting in lieu of the 2025 annual meeting of Pulmatrix stockholders, at which the Company's stockholder…Read full documentShow less
Plans to License or Monetize our Migraine and Inhalation Assets Continue FRAMINGHAM, Mass., Feb. 26, 2026 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced year-end and fourth quarter financial results for 2025 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the fourth quarter was to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies for the treatment of pain, cancer and other diseases. We continue to work with Cullgen for approval from the China Securities Regulatory Commission, or CSRC, one of the closing conditions of the Merger. Pulmatrix and Cullgen agreed to waive the "No Solicitation" clause in the Merger Agreement to permit each party to explore transactions that may benefit our respective companies while still seeking approval from the CSRC. In conjunction with the proposed merger, Pulmatrix is currently in a process to license or partner its patent portfolio encompassing our iSPERSE™ technology, as well as three related clinical programs, including our Phase 2 ready acute migraine program. Proposed Merger with Cullgen As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger"). If the proposed Merger is completed, the business of Cullgen will continue as the business of the combined company. Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025, and declared effective on May 9, 2025. On June 16, 2025, the Company held a special meeting in lieu of the 2025 annual meeting of Pulmatrix stockholders, at which the Company's stockholders approved the Merger and related proposals. The closing of the Merger is subject to other customary closing conditions, including Nasdaq's approval of the listing of the shares of Pulmatrix common stock to be issued in connection with the Merger and approval from the CSRC. On December 17, 2025, the Company and Cullgen mutually agreed to waive the "No Solicitation" clause in the Merger Agreement in order to permit each party to explore alternate transactions while continuing to work toward merger approval from the CSRC. Pulmatrix Currently Seeking License or Monetization of Clinical Assets and Proprietary iSPERSE™ Technology iSPERSE™ Technology iSPERSE™, also licensed to MannKind Corporation and Cipla Technologies for certain fields of use, utilizes particles that are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases. As of December 31, 2025, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 149 granted patents, 18 of which are U.S.-granted patents, plus approximately 48 pending patent applications in the U.S. and other jurisdictions. PUR3100 PUR3100, a Phase 2-ready asset, is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE™ dry powder inhalation technology for the treatment of acute migraine has a Food and Drug Administration acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in the peer-reviewed 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 ("NSKI"), 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 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. In 2024, Pulmatrix published an abstract titled "Ex vivo evaluation of the potential for Narrow Spectrum Kinase inhibitors as a treatment for Idiopathic Pulmonary Fibrosis". PUR1900 PUR1900, approved to proceed to a Phase 3 in India conducted by our partner Cipla, is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole being investigated for various indications. The Company and its partner, Cipla, wound down a Phase 2b trial that the Company was operating in 2024. Cipla has continued clinical development outside the United States, and in 2025 completed their Phase 2 study in India and have been approved by India's Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial. Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States should Cipla successfully market PUR1900 outside the United States. Within the United States, the Company and Cipla share the rights 50/50 and will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. Fourth Quarter and Year-End 2025 Financial Results Revenues decreased to nil for the year ended December 31, 2025, compared to $7.8 million for the year ended December 31, 2024. Revenues recognized for the year ended December 31, 2024, were primarily generated from the Cipla Agreement as related to our PUR1900 program, for which wind down activities were completed during the year ended December 31, 2024. Research and development expenses decreased approximately $7.1 million to less than $0.1 million for the year ended December 31, 2025, compared to $7.2 million for the year ended December 31, 2024. The decrease was primarily due to the wind down of the PUR1900 Phase 2b clinical trial, disposal of the Company's lab and facilities lease and employee terminations. General and administrative expenses decreased approximately $2.7 million to $5.1 million for the year ended December 31, 2025, compared to $7.8 million for the year ended December 31, 2024. The decrease was primarily due to decreased employment and other operating costs due to the previously mentioned wind down, partially offset by incurred costs related to the proposed Merger. The Company's total cash and cash equivalents balance as of December 31, 2025, was $4.1 million, compared to 9.5 million for the year ended December 31, 2024. The Company anticipates that its cash position, based on current operational efficiencies and prioritization of spending, is sufficient to fund its operations into the first quarter of 2027. About Pulmatrix, Inc. Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory 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 optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes. About iSPERSE™ Technology Pulmatrix's 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. For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html. 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 consummation of and the exact timing of the proposed Merger with Cullgen, the receipt of applicable regulatory approvals in connection with the proposed Merger with Cullgen, and satisfaction of closing conditions thereunder, among others; the Company's ability to divest its clinical assets on terms favorable to the Company, or at all, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market; 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, including the proposed Merger with Cullgen, 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: Chuck Padala Managing Director LifeSci Advisors 646-627-8390 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-announces-year-end-and-fourth-quarter-2025-financial-results-302698013.html
Investor releaseQuarter not tagged2025-10-16Pulmatrix Announces Third Quarter 2025 Financial Results and Divestment Plan for Migraine and Inhalation Assets
PR Newswire
Pulmatrix Announces Third Quarter 2025 Financial Results and Divestment Plan for Migraine and Inhalation Assets
As part of the proposed merger, Pulmatrix currently intends to divest its assets including its proprietary dry powder delivery technology, iSPERSE™, which enables delivery of small- or large-molecule drugs to the lungs by inhalation to treat migraine and respiratory diseases FRAMINGHAM, Mass., Oct. 16, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced third quarter financial results for 2025 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the third quarter has been to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies for the treatment of pain, cancer and other diseases. If consummated, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain, which Cullgen recently announced has completed enrollment. As part of the proposed merger, Pulmatrix is currently in a process to potentially divest its patent portfolio encompassing our iSPERSE™ technology, as well as three related clinical programs, including our Phase 2 ready acute migraine program." Proposed Merger with Cullgen As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger"). Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025, and declared effective on May 9, 2025. On June 16, 2025, the Company held a special meeting in lieu of the annual meeting of Pulmatrix stockholders, at which the C…Read full documentShow less
As part of the proposed merger, Pulmatrix currently intends to divest its assets including its proprietary dry powder delivery technology, iSPERSE™, which enables delivery of small- or large-molecule drugs to the lungs by inhalation to treat migraine and respiratory diseases FRAMINGHAM, Mass., Oct. 16, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced third quarter financial results for 2025 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the third quarter has been to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies for the treatment of pain, cancer and other diseases. If consummated, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain, which Cullgen recently announced has completed enrollment. As part of the proposed merger, Pulmatrix is currently in a process to potentially divest its patent portfolio encompassing our iSPERSE™ technology, as well as three related clinical programs, including our Phase 2 ready acute migraine program." Proposed Merger with Cullgen As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger"). Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025, and declared effective on May 9, 2025. On June 16, 2025, the Company held a special meeting in lieu of the annual meeting of Pulmatrix stockholders, at which the Company's stockholders approved the Merger and related proposals. The Closing is subject to other customary closing conditions, including Nasdaq's approval of the listing of the shares of Pulmatrix common stock to be issued in connection with the Merger and approval from the China Security Regulatory Commission. If the proposed Merger is completed, the business of Cullgen will continue as the business of the combined company. Pulmatrix Currently Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology iSPERSE™ Technology iSPERSE™ particles are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases. As of September 30, 2025, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 146 granted patents, 18 of which are U.S.-granted patents, plus approximately 50 pending patent applications in the U.S. and other jurisdictions. PUR3100 PUR3100 is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE™ dry powder inhalation technology for the treatment of acute migraine and is a Phase 2-ready asset with a Food and Drug Administration acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in the peer-reviewed 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 ("NSKI"), 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 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. In 2024, Pulmatrix published an abstract titled "Ex vivo evaluation of the potential for Narrow Spectrum Kinase inhibitors as a treatment for Idiopathic Pulmonary Fibrosis". PUR1900 PUR1900 is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole being investigated for various indications. The Company and its partner, Cipla, wound down a Phase 2b trial that the Company was operating in 2024. Cipla has continued clinical development outside the United States and in 2025 advised Pulmatrix that they have completed their Phase 2 study in India and have been approved by India's Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial. Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States should Cipla successfully market PUR1900 outside the United States. Within the United States, the Company and Cipla will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. Third Quarter 2025 Financial Results Revenues decreased approximately $0.4 million to $0 for the three months ended September 30, 2025, compared to $0.4 million for the three months ended September 30, 2024. The decrease is primarily related to completion of the wind down of the PUR1900 Phase 2b clinical trial during the year ended December 31, 2024. Research and development expenses decreased approximately $0.8 million to less than $0.1 million for the three months ended September 30, 2025, compared to $0.8 million for the three months ended September 30, 2024. The decrease was primarily due to winding down the PUR1900 Phase 2b clinical trial, disposal of the Company's lab and facilities lease and employee terminations. General and administrative expenses decreased approximately $1.4 million to $0.9 million for the three months ended September 30, 2025, compared to $2.2 million for the three months ended September 30, 2024. The decrease was primarily due to decreased employment and other operating costs due to the previously mentioned winddown, partially offset by incurred costs related to the proposed Merger. The Company's total cash and cash equivalents balance as of September 30, 2025, was $4.8 million. The Company anticipates that its cash position, based on current operational efficiencies and prioritization of spending, is sufficient to fund its operations into the fourth quarter of 2026. About Pulmatrix, Inc. Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory 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 optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes. About iSPERSE™ Technology Pulmatrix's 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. For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html. 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 consummation of and the exact timing of the proposed Merger with Cullgen, the receipt of applicable regulatory approvals in connection with the proposed Merger with Cullgen, and satisfaction of closing conditions thereunder, among others; the Company's ability to divest its clinical assets on terms favorable to the Company, or at all, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market; 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, including the proposed Merger with Cullgen, 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: Chuck Padala Managing Director LifeSci Advisors 646-627-8390 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-announces-third-quarter-2025-financial-results-and-divestment-plan-for-migraine-and-inhalation-assets-302585702.html
Investor releaseQuarter not tagged2025-08-06Pulmatrix Announces Second Quarter 2025 Financial Results and Divestment Plan for Inhalation Assets
PR Newswire
Pulmatrix Announces Second Quarter 2025 Financial Results and Divestment Plan for Inhalation Assets
Proposed merger anticipated to close in 2025 As part of the proposed merger, Pulmatrix currently intends to divest its assets including its proprietary dry powder delivery technology, iSPERSE™, which enables delivery of small or large molecule drugs to the lungs by inhalation FRAMINGHAM, Mass., Aug, 6, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced second quarter financial results for 2025 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the second quarter has been to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies for the treatment of pain, cancer and other diseases. During the quarter, the SEC declared our registration statement effective and our stockholders approved the Merger, which will be completed subject to certain closing conditions, including approval from Nasdaq and the China Security Regulatory Commission. If consummated, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain. As part of the proposed merger, Pulmatrix is currently in a process to potentially divest its patent portfolio for our iSPERSE™ technology, as well as three related clinical programs." Proposed Merger with Cullgen As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), PCL Merger Sub, Inc. and PCL Merger Sub II, LLC, as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger"). Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17,…Read full documentShow less
Proposed merger anticipated to close in 2025 As part of the proposed merger, Pulmatrix currently intends to divest its assets including its proprietary dry powder delivery technology, iSPERSE™, which enables delivery of small or large molecule drugs to the lungs by inhalation FRAMINGHAM, Mass., Aug, 6, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced second quarter financial results for 2025 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the second quarter has been to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies for the treatment of pain, cancer and other diseases. During the quarter, the SEC declared our registration statement effective and our stockholders approved the Merger, which will be completed subject to certain closing conditions, including approval from Nasdaq and the China Security Regulatory Commission. If consummated, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain. As part of the proposed merger, Pulmatrix is currently in a process to potentially divest its patent portfolio for our iSPERSE™ technology, as well as three related clinical programs." Proposed Merger with Cullgen As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), PCL Merger Sub, Inc. and PCL Merger Sub II, LLC, as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger"). Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025, and declared effective on May 9, 2025. On June 16, 2025, the Company held a special meeting in lieu of the annual meeting of Pulmatrix stockholders, at which the Company's stockholders approved the Merger and related proposals. The Closing is subject to other customary closing conditions, including Nasdaq's approval of the listing of the shares of Pulmatrix common stock to be issued in connection with the Merger and approval from the China Security Regulatory Commission. The proposed Merger is anticipated to close in 2025, subject to the satisfaction of the aforementioned closing conditions, among others, however the exact timing of the consummation of the proposed Merger cannot be predicted. If the proposed Merger is completed, the business of Cullgen will continue as the business of the combined company. Pulmatrix Currently Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology iSPERSE™ Technology iSPERSE™ particles are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases. As of June 30, 2025, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 146 granted patents, 18 of which are granted U.S. patents, and approximately 54 additional pending patent applications in the U.S. and other jurisdictions. PUR3100 PUR3100 is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE™ dry powder inhalation technology for the treatment of acute migraine. In 2023, Pulmatrix announced the Food and Drug Administration's acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study, positioning PUR3100 as a Phase 2-ready asset. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in a peer-reviewed 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 ("NSKI"), 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. 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. The Company completed all Phase 2b wind down activities in the third quarter of 2024. With the study wind down complete, Pulmatrix bears no further financial responsibility for the development of PUR1900. The Company's partner Cipla has continued clinical development outside the United States and has advised us that they have completed their Phase 2 study in India and have been approved by India's Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial. Should Cipla successfully market PUR1900 outside the United States, Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States. Within the United States, the Company and Cipla will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. Second Quarter 2025 Financial Results Revenues decreased approximately $1.6 million to $0 for the three months ended June 30, 2025, compared to $1.6 million for the three months ended June 30, 2024. The decrease is primarily related to completion of the wind down of the PUR1900 Phase 2b clinical trial during the year ended December 31, 2024. Research and development expenses decreased approximately $2.8 million to less than $0.1 million for the three months ended June 30, 2025, compared to $2.8 million for the three months ended June 30, 2024. The decrease was primarily due to winding down the PUR1900 Phase 2b clinical trial, disposal of the Company's lab and facilities lease and employee terminations. General and administrative expenses decreased approximately $0.5 million to $1.5 million for the three months ended June 30, 2025, compared to $2.0 million for the three months ended June 30, 2024. The decrease was primarily due to decreased employment and other operating costs, partially offset by incurred costs related to the proposed Merger. The Company's total cash and cash equivalents balance as of June 30, 2025, was $5.8 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations at least through the anticipated closing of the proposed Merger with Cullgen. About Pulmatrix, Inc. Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory 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 optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes. About iSPERSE™ Technology Pulmatrix's 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. For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html. 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 consummation of and the exact timing of the proposed Merger with Cullgen and satisfaction of closing conditions thereunder, among others; the Company's ability to divest its clinical assets on terms favorable to the Company, or at all, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market; 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, including the proposed Merger with Cullgen, 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: Chuck Padala Managing Director LifeSci Advisors 646-627-8390 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-announces-second-quarter-2025-financial-results-and-divestment-plan-for-inhalation-assets-302522900.html SOURCE Pulmatrix Inc.
Investor releaseQuarter not tagged2025-05-15Pulmatrix Announces First Quarter 2025 Financial Results and Divestment Plan for Assets
PR Newswire
Pulmatrix Announces First Quarter 2025 Financial Results and Divestment Plan for Assets
Registration statement for proposed Cullgen merger declared effective by the SEC Proposed merger anticipated to close in June As part of proposed merger, Pulmatrix currently intends to divest its assets including its Phase 2-ready acute migraine candidate, PUR3100, and other development candidates based on its iSPERSE™ technology FRAMINGHAM, Mass., May 15, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced first quarter financial results for 2025 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the first quarter has been to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE™ platform to discover and advance therapeutics for the treatment of cancer and other diseases. If successful, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain. As part of the proposed merger, Pulmatrix is currently in a process to divest its clinical assets, including our Phase 2-ready acute migraine product candidate PUR3100, along with our iSPERSE™ technology." Proposed Merger with Cullgen As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger"). The proposed Merger is anticipated to close in June 2025, subject to the satisfaction of certain closing conditions, among others, however the exact timing of the consummation of the proposed Merger cannot be predicted. Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on…Read full documentShow less
Registration statement for proposed Cullgen merger declared effective by the SEC Proposed merger anticipated to close in June As part of proposed merger, Pulmatrix currently intends to divest its assets including its Phase 2-ready acute migraine candidate, PUR3100, and other development candidates based on its iSPERSE™ technology FRAMINGHAM, Mass., May 15, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced first quarter financial results for 2025 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the first quarter has been to advance steps to complete the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE™ platform to discover and advance therapeutics for the treatment of cancer and other diseases. If successful, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain. As part of the proposed merger, Pulmatrix is currently in a process to divest its clinical assets, including our Phase 2-ready acute migraine product candidate PUR3100, along with our iSPERSE™ technology." Proposed Merger with Cullgen As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen Inc. ("Cullgen"), as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and such transaction, the "Merger"). The proposed Merger is anticipated to close in June 2025, subject to the satisfaction of certain closing conditions, among others, however the exact timing of the consummation of the proposed Merger cannot be predicted. Additional information about the Merger Agreement and proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025. Pulmatrix Currently Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology PUR3100 PUR3100 is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE™ dry powder inhalation technology for the treatment of acute migraine. In 2023, Pulmatrix announced the Food and Drug Administration's acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study, positioning PUR3100 as a Phase 2-ready asset. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in a peer-reviewed 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 ("NSKI"), 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. 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. The Company completed all Phase 2b wind down activities in the third quarter of 2024. With the study wind down complete, Pulmatrix bears no further financial responsibility for the development of PUR1900. The Company's partner Cipla has continued clinical development outside the United States and has advised us that they have completed their Phase 2 study in India and have been approved by India's Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial. Should Cipla successfully market PUR1900 outside the United States, Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States. Within the United States, the Company and Cipla will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. iSPERSE™ Technology iSPERSE™ particles are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases. As of March 31, 2025, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 146 granted patents, 18 of which are granted U.S. patents, with expiration dates from 2026 to 2037, and approximately 48 additional pending patent applications in the U.S. and other jurisdictions. First Quarter 2025 Financial Results Revenues decreased approximately $5.9 million to $0 for the three months ended March 31, 2025, compared to $5.9 million for the three months ended March 31, 2024. The decrease is primarily related to completion of the wind down of the PUR1900 Phase 2b clinical trial during the year ended December 31, 2024. Research and development expenses decreased approximately $3.5 million to less than $0.1 million for the three months ended March 31, 2025, compared to $3.5 million for the three months ended March 31, 2024. The decrease was primarily due to winding down the PUR1900 Phase 2b clinical trial, disposal of the Company's lab and facilities lease and employee terminations. General and administrative expenses increased approximately $0.2 million to $1.8 million for the three months ended March 31, 2025, compared to $1.6 million for the three months ended March 31, 2024. The increase was primarily due to incurred costs related to the proposed Merger, partially offset by decreased employment and other operating costs. The Company's total cash and cash equivalents balance as of March 31, 2025, was $7.7 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations at least through the anticipated closing of the proposed Merger with Cullgen. About Pulmatrix, Inc. Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory 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 optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes. About iSPERSE™ Technology Pulmatrix's 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. For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html. 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 consummation of and the exact timing of the proposed Merger with Cullgen and satisfaction of closing conditions thereunder, among others; the Company's ability to divest its clinical assets on terms favorable to the Company, or at all, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market; 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, including the proposed Merger with Cullgen, 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: Chuck Padala Managing Director LifeSci Advisors 646-627-8390 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-announces-first-quarter-2025-financial-results-and-divestment-plan-for-assets-302456356.html SOURCE Pulmatrix Inc.
Investor releaseQuarter not tagged2025-03-21Pulmatrix Announces Year-End and Fourth Quarter 2024 Financial Results and Divestment Plan for Assets
PR Newswire
Pulmatrix Announces Year-End and Fourth Quarter 2024 Financial Results and Divestment Plan for Assets
Announced merger agreement with Cullgen in November, anticipated to close in the first half of 2025 As part of proposed merger, Pulmatrix intends to divest its assets including its Phase 2-ready acute migraine candidate, PUR3100, and other development candidates based on its iSPERSE™ technology FRAMINGHAM, Mass., March 21, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced fourth quarter and year-end financial results for 2024 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the fourth quarter has been to advance the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE™ platform to discover and advance therapeutics for the treatment of cancer and other diseases. If successful, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in or about to initiate Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain. As part of the proposed merger, Pulmatrix is in a process to divest its clinical assets, including iSPERSE™ and our Phase 2 ready acute migraine product." Proposed Merger with Cullgen As previously reported, on November 13, 2024, following a review of strategic alternatives, the Company announced it had entered into an agreement and plan of merger (the "Merger Agreement" and such transaction, the "Merger") with Cullgen Inc. ("Cullgen"). The Merger is anticipated to close in the first half of 2025, subject to the satisfaction of certain closing conditions, among others, however the exact timing of the consummation of the Merger cannot be predicted. Additional information about the Merger Agreement was previously disclosed on a Current Report on Form 8-K filed with the SEC on November 13, 2024, and in a registration statement on Form S-4 filed with the SEC on February 14, 2025. Pulmatrix Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology PUR3100 PUR3…Read full documentShow less
Announced merger agreement with Cullgen in November, anticipated to close in the first half of 2025 As part of proposed merger, Pulmatrix intends to divest its assets including its Phase 2-ready acute migraine candidate, PUR3100, and other development candidates based on its iSPERSE™ technology FRAMINGHAM, Mass., March 21, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™ technology, today announced fourth quarter and year-end financial results for 2024 and provided a corporate update. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the fourth quarter has been to advance the proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE™ platform to discover and advance therapeutics for the treatment of cancer and other diseases. If successful, the proposed merger would create a Nasdaq-listed company focusing on targeted protein degradation technology with three degrader programs in or about to initiate Phase 1 clinical trials – two for the treatment of cancer and one for the treatment of acute and chronic pain. As part of the proposed merger, Pulmatrix is in a process to divest its clinical assets, including iSPERSE™ and our Phase 2 ready acute migraine product." Proposed Merger with Cullgen As previously reported, on November 13, 2024, following a review of strategic alternatives, the Company announced it had entered into an agreement and plan of merger (the "Merger Agreement" and such transaction, the "Merger") with Cullgen Inc. ("Cullgen"). The Merger is anticipated to close in the first half of 2025, subject to the satisfaction of certain closing conditions, among others, however the exact timing of the consummation of the Merger cannot be predicted. Additional information about the Merger Agreement was previously disclosed on a Current Report on Form 8-K filed with the SEC on November 13, 2024, and in a registration statement on Form S-4 filed with the SEC on February 14, 2025. Pulmatrix Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology PUR3100 PUR3100 is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE dry powder inhalation technology for the treatment of acute migraine. In 2023, Pulmatrix announced the Food and Drug Administration's acceptance of an Investigational New Drug ("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 of PUR3100, which were published in 2024 in a peer-reviewed 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 ("NSKI"), 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. 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. Per an updated agreement with its partner Cipla, Pulmatrix has stopped patient enrollment for the Phase 2b study of PUR1900 while Cipla has continued their Phae 2 trial outside the United States. The decision to stop the study was unrelated to any safety concerns. The Phase 2b study had been ongoing since the first quarter of 2023. The Company completed all Phase 2b wind down activities within the third quarter of 2024 as planned. With the study wind down complete, Pulmatrix bears 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. iSPERSE™ Technology iSPERSE™ particles are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases. As of December 31, 2024, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 149 granted patents, 19 of which are granted U.S. patents, with expiration dates from 2024 to 2037, and approximately 50 additional pending patent applications in the U.S. and other jurisdictions. Fourth Quarter and Year-End 2024 Financial Results Revenues increased approximately $0.5 million to $7.8 million for the year ended December 31, 2024, compared to $7.3 million for the year ended December 31, 2023. The increase is primarily related to a contract modification of the Cipla Agreement which resulted in a cumulative catch-up adjustment recorded during the year ended December 31, 2024. Research and development expenses decreased approximately $8.4 million to $7.2 million for the year ended December 31, 2024, compared to $15.5 million for the year ended December 31, 2023. The decrease was primarily due to winding down the PUR1900 Phase 2b clinical trial, disposal of the Company's lab and facilities lease and employee terminations. General and administrative expenses increased approximately $1.3 million to $7.8 million for the year ended December 31, 2024, compared to $6.5 million for the year ended December 31, 2023. The increase was primarily due to incurred legal and professional services costs and one-time employee separation costs, partially offset by decreased rent and other operating costs. The Company recognized a $2.6 million loss on its transactions with MannKind Corporation, which closed during the third quarter of 2024, representing the write-down for the fair value of assets transferred to MannKind Corporation. The Company's total cash and cash equivalents balance as of December 31, 2024, was $9.5 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations at least through the anticipated closing of the Merger with Cullgen. About Pulmatrix, Inc. Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory 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 optimizing pharmacokinetics and reducing systemic side effects to improve patient outcomes. About iSPERSE™ Technology Pulmatrix's 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. For more on the Company's inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html. 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 consummation of the proposed Merger with Cullgen and satisfaction of closing conditions thereunder, among others, the Company's ability to maintain compliance with the listing standards of the Nasdaq Capital Market, 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, including the proposed Merger with Cullgen, 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: Chuck Padala Managing Director LifeSci Advisors 646-627-8390 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-announces-year-end-and-fourth-quarter-2024-financial-results-and-divestment-plan-for-assets-302407628.html SOURCE Pulmatrix Inc.

