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Globe and Mail
3 days ago
- Business
- Globe and Mail
Pulmatrix (PULM) Q2 Revenue Falls 100%
Key Points GAAP revenue dropped to zero in Q2 2025, with no new product sales or clinical trial sponsorships. Net loss per share (GAAP) was $(0.42) in Q2 2025, reflecting significant spending cuts and a substantial reduction in R&D activity. Pulmatrix focused on finalizing its merger with Cullgen and pursuing asset divestitures; no forward financial guidance was provided. These 10 stocks could mint the next wave of millionaires › Pulmatrix (NASDAQ:PULM), a biotechnology company known for its dry powder inhalation delivery platform iSPERSE™, released its second quarter results on August 6, 2025, covering the quarter that ended June 30, 2025. Pulmatrix reported zero revenue for the period ended June 30, 2025. Net loss per share (GAAP) was $(0.42), compared to $(1.59) in Q2 2024. There were no Wall Street analyst estimates available this quarter, but the reported GAAP loss per share of $(0.42) represented a substantial narrowing from last year's GAAP result of $(1.59) in Q2 2024, mainly due to a near-total reduction in research and development spending. The quarter highlights Pulmatrix's strategic pivot: winding down its prior clinical business, trimming operational costs, conserving cash, and focusing on completing its merger with Cullgen. The company offered no forward guidance for upcoming quarters as it transitions operations. Business Overview and Recent Areas of Focus Pulmatrix's core business has centered on developing inhaled therapies using its proprietary iSPERSE™ technology—a dry powder drug delivery platform aimed at improving medication delivery to the lungs. This platform was designed to increase efficiency and tolerability in treatments compared to traditional inhalers or oral medications, positioning the company in the respiratory therapeutics space. Over the past year, Pulmatrix's strategic priorities have shifted dramatically. It has halted most clinical operations, halted R&D spending, and now seeks to divest its iSPERSE™ intellectual property and remaining clinical assets. The company's ongoing viability depends on successfully completing its pending merger with Cullgen and monetizing its assets or securing royalty streams from former drug candidates such as PUR1900. Key success factors now rest less on product development and more on the execution of these strategic transactions. Quarter Highlights: Operations, Finances, and Pipeline Progress The quarter reflected a sharp operational downsizing as Pulmatrix's GAAP revenue dropped from $1.6 million in Q2 2024 to zero. This change resulted from the completion of the wind-down of its PUR1900 clinical trial. Former sources of operating income, such as milestone payments or funding for joint studies, concluded, and there were no new business or sales streams to replace them during the period. Research and development expense (GAAP) decreased from $2,834,000 in Q2 2024 to $14,000, a 99.5% drop. This near-total reduction in research spending came as Pulmatrix finished closing its flagship clinical programs and terminated related staff. The company stated: '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.' Helped by layoffs and cuts, although these savings were partially offset by legal and advisory expenses linked to the merger process. Net loss and operating loss (GAAP) both narrowed substantially. The reduced losses were primarily due to a sharp decrease in R&D expenses. Net loss (GAAP) dropped to $(1.55) million from $(5.81) million in Q2 2024. The company avoided any unusual charges this quarter, whereas the prior period had included a significant loss from an asset transaction with MannKind. With its extreme cost containment, Pulmatrix exited the quarter with a GAAP cash and cash equivalents position of $5.8 million (down from $9.5 million at December 31, 2024), which management expects will fund operations until the Cullgen merger is finalized. This period also saw Pulmatrix focus on two main strategic moves apart from operational cuts: the attempted sale of its iSPERSE™ intellectual property and clinical programs, and its merger with Cullgen. The company openly stated, 'Pulmatrix is currently in a process to potentially divest its patent portfolio for our iSPERSE™ technology, as well as three related clinical programs.' These pipeline programs include PUR3100 for acute migraine (an orally inhaled dihydroergotamine engineered with iSPERSE™), PUR1800 for chronic obstructive pulmonary disease (a kinase inhibitor also using the iSPERSE™ platform), and PUR1900 (an inhaled formulation of an antifungal, developed with Cipla). Development or commercial responsibility for these candidates has ended or shifted to partners, and Pulmatrix itself has no ongoing clinical trials. Regulatory milestones from past years continued to carry some legacy value. For example, the Food and Drug Administration had accepted a Phase 2 study for PUR3100 and Pulmatrix's partner Cipla is moving forward with Phase 3 for PUR1900 in India. Pulmatrix may be eligible to receive a 2% royalty on possible future non-U.S. sales of PUR1900, but this would only occur if the product is successfully commercialized—a long-term and uncertain proposition. The most critical development during the second quarter was continued progress toward completing the merger with Cullgen, a protein degrader drug development company. Pulmatrix received stockholder approval and had its registration statement declared effective by the Securities and Exchange Commission. The merger remains contingent on regulatory approvals, including from the China Security Regulatory Commission and Nasdaq. Until the deal closes, Pulmatrix is in a holding pattern, and the company highlights that any delay or failure in closing poses significant risks to its ongoing viability. Looking Ahead: Guidance and Watchpoints Pulmatrix did not provide any financial guidance or operational outlook for the next quarter or upcoming year. No revenue or earnings forecast was offered by management in the latest earnings release. The company's leadership made clear that the near-term objective is to complete the planned merger and monetize or transfer its remaining assets. Because Pulmatrix is not currently developing or selling any medications, its short-term future is heavily dependent on successful asset divestitures and getting the Cullgen deal across the finish line. Investors and observers should monitor progress toward merger closing, potential updates on the sale of iSPERSE™-related patent portfolios, and any royalty developments with former pipeline candidates. PULM does not currently pay a dividend. Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted. Where to invest $1,000 right now When our analyst team has a stock tip, it can pay to listen. After all, Stock Advisor's total average return is 1,026%* — a market-crushing outperformance compared to 180% for the S&P 500. They just revealed what they believe are the 10 best stocks for investors to buy right now, available when you join Stock Advisor. See the stocks » *Stock Advisor returns as of August 4, 2025
Yahoo
21-03-2025
- Business
- Yahoo
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 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 $9.5 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations at least through the anticipated closing of the Merger with Cullgen. PULMATRIX, Balance Sheets(in thousands, except share and per share data)December 31, 2024 December 31, 2023 Assets Current assets: Cash and cash equivalents$ 9,521 $ 19,173Accounts receivable -928Prepaid expenses and other current assets 399742Total current assets 9,92020,843Property and equipment, net -1,158Operating lease right-of-use asset -10,309Long-term restricted cash 101,472Other long-term assets 13176Total assets$ 9,943 $ 33,958Liabilities and stockholders' equity Current liabilities: Accounts payable$ 809 $ 1,915Accrued expenses and other current liabilities 120947Operating lease liability -429Deferred revenue -618Total current liabilities 9293,909Warrant liability 67-Deferred revenue, net of current portion -3,727Operating lease liability, net of current portion -8,327Total liabilities 99615,963Stockholders' equity: Preferred stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; noshares issued and outstanding at December 31, 2024 and December 31, 2023 --Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 shares issued and outstanding at December31, 2024 and December 31, 2023 --Additional paid-in capital 306,103305,592Accumulated deficit (297,156)(287,597)Total stockholders' equity 8,94717,995Total liabilities and stockholders' equity$ 9,943 $ 33,958 PULMATRIX, Statements of Operations(in thousands, except share and per share data)Year Ended December 31, 20242023 Revenues$ 7,806 $ 7,298 Operating expenses: Research and development 7,16615,518General and administrative 7,7856,520Loss on MannKind Transaction 2,618-Total operating expenses 17,56922,038Loss from operations (9,763)(14,740)Other income (expense): Interest income 467867Fair value adjustment of warrants (67)-Other expense, net (196)(248)Total other income, net 204619Net loss$ (9,559) $ (14,121)Net loss per share attributable to common stockholders – basic anddiluted$ (2.62) $ (3.87)Weighted average common shares outstanding – basic and diluted 3,652,2853,651,911About 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™ TechnologyPulmatrix'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: 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. 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 PadalaManaging DirectorLifeSci Advisors646-627-8390chuck@ View original content to download multimedia: SOURCE Pulmatrix Inc. Sign in to access your portfolio
