Dihydroergotamine Mesylate

Four FDA-approved products strengthen portfolio and reaffirm commitment to global reach By integrating this portfolio with our existing capabilities, we focus to reach further into markets where high-quality generic medicines make the greatest difference,” — Steen Vangsgaard ANDERLECHT, BRUSSELS, BELGIUM, September 9, 2025 / EINPresswire.com / -- A.forall is pleased to announce the acquisition of four FDA-approved injectable generics and two late-stage pipeline assets from Provepharm's US portfolio. With this acquisition, A.forall considerably extends its marketed portfolio in the US, marking a significant expansion of its US footprint and a key milestone in the company’s sharpened focus on high-quality generics worldwide. Strengthening Essential Healthcare The acquired portfolio includes four well-established hospital products that address critical therapeutic needs: • Dihydroergotamine Mesylate (neurology – for the treatment of migraine and cluster headaches) • Piperacillin/Tazobactam (infectious disease – broad-spectrum antibiotic for hospital-acquired infections) • Tranexamic Acid (hematology – to control bleeding in surgical and trauma settings) • Phenylephrine Hydrochloride (anesthesiology – to manage hypotension during surgery) These medicines are widely integrated in US hospital protocols and marketed via established pharmaceutical distributors and group purchasing organizations, ensuring strong clinical familiarity among healthcare professionals. The newly acquired products will be commercialized through A.forall’s US subsidiary, Milla Pharmaceuticals Inc . The two late-stage pipeline products target complementary therapeutic areas and are expected to launch in the coming years. Steen Vangsgaard, CEO of A.forall, comments: “This acquisition fits perfectly with our renewed strategy to develop, commercialize and add value to medicines, increasing their availability where they matter most. These products expand our US relevance and give us immediate access to a robust portfolio that meets essential therapeutic needs. It’s a strategic investment that delivers scale, diversification and valuable cross-selling opportunities.” Strategic US Focus For A.forall, the US is a strategic priority. With a dedicated team on the ground, strong partnerships and a robust pipeline, the company continues to invest in one of the world’s most competitive and complex healthcare environments. Since 2017, six products of A.forall were registered successfully in the US market, demonstrating consistent growth and commitment to American healthcare providers. "By integrating this portfolio with our existing capabilities, we focus to reach further into markets where high-quality generic medicines make the greatest difference," Vangsgaard adds. "This acquisition strengthens our brand recognition and significantly expands our commercial presence in the world's largest pharmaceutical market." This acquisition follows the recent decision to divest A.forall's Retail & Hospital division and focus entirely on generics: a strategy that gives the company a sharper scope, stronger momentum and a clear direction for growth. About A.forall A.forall is a Belgian pharmaceutical group with headquarters in Anderlecht and offices in Ireland and the United States. At current, the company employs over 144 people and distributes a wide range of pharmaceutical products to pharmacies, wholesalers, hospitals and retirement homes. A.forall is also a global player in the generics market, now with 35+ molecules on the European and U.S. market and a fully stocked pipeline of mainly injectable generics and value-added products covering various therapeutic areas. Driven by one mission #MakingAffordableMedicinesAvailableToAll, A.forall focuses 100% on the development, licensing and commercialization of generic medicines worldwide. A.forall is part of The Riverside Company's portfolio, a global investment firm focused on the smaller end of the middle market that has invested in more than 220 healthcare companies since 1988. For more information, visit: www.aforallpharma.com . We’re happy to provide additional context or answer any questions you may have. For media inquiries or more information, please contact: A.forall Group NV Communication Department A.forall +32 2 526 64 14 communications@aforallpharma.com Visit us on social media: LinkedIn Steen Vangsgaard on the US expansion Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

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. PULMATRIX, INC. Consolidated Balance Sheets (in thousands, except share and per share data) June 30, 2025 December 31, 2024 (unaudited) Assets Current assets: Cash and cash equivalents $ 5,825 $ 9,521 Prepaid expenses and other current assets 317 399 Total current assets 6,142 9,920 Long-term restricted cash 10 10 Other long-term assets - 13 Total assets $ 6,152 $ 9,943 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 384 $ 809 Accrued expenses and other current liabilities 164 120 Total current liabilities 548 929 Warrant liability - 67 Total liabilities 548 996 Stockholders' equity: Preferred Stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at June 30, 2025 and December 31, 2024 - - Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 shares issued and outstanding at June 30, 2025 and December 31, 2024 - - Additional paid-in capital 306,117 306,103 Accumulated deficit (300,513) (297,156) Total stockholders' equity 5,604 8,947 Total liabilities and stockholders' equity $ 6,152 $ 9,943 PULMATRIX, INC. Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenues $ - $ 1,552 $ - $ 7,437 Operating expenses: Research and development 14 2,834 33 6,346 General and administrative 1,534 2,001 3,362 3,627 Loss on MannKind Transaction - 2,618 - 2,618 Total operating expenses 1,548 7,453 3,395 12,591 Loss from operations (1,548) (5,901) (3,395) (5,154) Other income (expense): Interest income 41 133 94 293 Fair value adjustment of warrants 1 - 67 - Other expense, net (43) (43) (123) (125) Total other income (expense), net (1) 90 38 168 Net loss $ (1,549) $ (5,811) $ (3,357) $ (4,986) Net loss per share attributable to common stockholders – basic and diluted $ (0.42) $ (1.59) $ (0.92) $ (1.37) Weighted average common shares outstanding – basic and diluted 3,652,285 3,652,285 3,652,285 3,652,285 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 chuck@lifesciadvisors.com SOURCE Pulmatrix Inc.