Plans to License or Monetize our Migraine and Inhalation Assets Continue
Proposed Merger with Cullgen
As previously reported, on
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 "
On
On
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 areU.S. -granted patents, plus approximately 48 pending patent applications in theU.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 aFood 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 outsidethe United States , and in 2025 completed their Phase 2 study inIndia and have been approved byIndia'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 outsidethe United States should Cipla successfully market PUR1900 outsidethe United States . Withinthe 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
Research and development expenses decreased approximately
General and administrative expenses decreased approximately
The Company's total cash and cash equivalents balance as of
Consolidated Balance Sheets | ||||||||
(in thousands, except share and per share data) | ||||||||
| 2024 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,088 | $ | 9,521 | ||||
Prepaid expenses and other current assets | 41 | 399 | ||||||
Total current assets | 4,129 | 9,920 | ||||||
Long-term restricted cash | 10 | 10 | ||||||
Other long-term assets | - | 13 | ||||||
Total assets | $ | 4,139 | $ | 9,943 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 272 | $ | 809 | ||||
Accrued expenses and other current liabilities | 57 | 120 | ||||||
Total current liabilities | 329 | 929 | ||||||
Warrant liability | - | 67 | ||||||
Total liabilities | 329 | 996 | ||||||
Stockholders' equity: | ||||||||
Preferred stock, | - | - | ||||||
Common stock, | - | - | ||||||
Additional paid-in capital | 306,128 | 306,103 | ||||||
Accumulated deficit | (302,318) | (297,156) | ||||||
Total stockholders' equity | 3,810 | 8,947 | ||||||
Total liabilities and stockholders' equity | $ | 4,139 | $ | 9,943 | ||||
Consolidated Statements of Operations | ||||||||
(in thousands, except share and per share data) | ||||||||
Year Ended | ||||||||
2025 | 2024 | |||||||
Revenues | $ | - | $ | 7,806 | ||||
Operating expenses: | ||||||||
Research and development | 38 | 7,166 | ||||||
General and administrative | 5,131 | 7,785 | ||||||
Loss on MannKind Transaction | - | 2,618 | ||||||
Total operating expenses | 5,169 | 17,569 | ||||||
Loss from operations | (5,169) | (9,763) | ||||||
Other income (expense): | ||||||||
Interest income | 144 | 467 | ||||||
Fair value adjustment of warrants | 67 | (67) | ||||||
Other expense, net | (204) | (196) | ||||||
Total other income (expense), net | 7 | 204 | ||||||
Net loss | $ | (5,162) | $ | (9,559) | ||||
Net loss per share attributable to common stockholders – basic and diluted | $ | (1.41) | $ | (2.62) | ||||
Weighted average common shares outstanding – basic and diluted | 3,652,285 | 3,652,285 | ||||||
About
About iSPERSE™ Technology
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:
Managing Director
646-627-8390
chuck@lifesciadvisors.com
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