Lee's Pharmaceutical Holdings Ltd.

Acquisition of Staccato® One Breath Technology®, a proprietary platform technology with broad therapeutic potential Synergistic and complementary to Lee's Pharm's existing products pipeline, and Acquisition of rights as licensor and manufacturer of Staccato® alprazolam under a global partnership with UCB HONG KONG, Dec. 11, 2025 /PRNewswire/ -- Nova Pneuma Inc. ("NPI"), the Delaware incorporated and wholly owned subsidiary of Lee's Pharmaceutical Holdings Limited (0950.HK) ("Lee's Pharm" or the "Company"), announced today the assets acquisition from Alexza Pharmaceuticals, Inc. ("Alexza"). The transaction grants Lee's Pharm and NPI, the full ownership of the Staccato® One Breath Technology® ("Staccato® OBT®") platform and assets in relation to Staccato® OBT®, including intellectual property, know-how, trademarks, product pipeline, equipment, products and access to GMP facility, and Alexza's right as licensor and manufacturer of Staccato® alprazolam. This strategic move strengthens Lee's Pharm's aerosolized inhalation drug delivery capabilities, expands the Company's inhalation product pipeline, and aligns with the Company's global expansion strategy. Continue Reading GMP Facility, Fremont CA The transaction remains subject to certain closing conditions and is expected to close by the end of 2025. Proprietary And Well-Validated Staccato® One Breath Technology® The acquisition of the Staccato® OBT® platform represents a major step forward for the Company, granting full ownership of this technology platform which is a well-validated and proven platform supported by approved product, Adasuve®, and several Staccato® based late-stage development programs. This strategic move strengthens the Company's drug delivery capabilities and positions it to drive future innovation in inhalation therapeutics. Synergistic and Complementary to Lee's Pharm's Existing Products Pipeline The transaction also delivers significant synergies with the Company's existing pipeline. The Company has been advancing its clinical development of Staccato® based medicine for cancer-related breakthrough pain and started commercializing Adasuve® for acute agitation in adult schizophrenia or bipolar I disorder across Greater China. Upon completion of the acquisition, all licensing payment obligations payable thereafter by Lee's Pharm to Alexza for the development and commercialization of Staccato® based medicine and Adasuve®, will be eliminated, delivering immediate cost savings and enhancing overall deal economics. In addition, two promising CNS pipeline assets targeting Parkinson's disease and Cyclic Vomiting Syndrome (CVS), both at Phase 2 clinical stage, will be integrated into the Company's portfolio, unlocking new commercial opportunities. Acquisition of Rights as Licensor and Manufacturer of Staccato® alprazolam Under a Global Partnership With UCB Complementing these benefits, the Company acquires Alexza's rights and obligations under the existing worldwide licensing and manufacturing supply agreement with UCB, a biopharmaceutical with strong presence in epilepsy treatment. Under this agreement, UCB holds and will keep global development and commercialization rights for Staccato® alprazolam, which is currently in Phase 3 clinical trial (CinicalTrial.gov ID: NCT05077904), reinforcing the clinical maturity and commercial potential of the Staccato® OBT® platform. UCB acquired Engaged Therapeutics, Inc. for Staccato® alprazolam in June 2020 and entered into an updated license and related commercial supply agreement with Alexza.[1] Subject to achieving specified development, regulatory, and sales milestones, Lee's Pharm together with NPI may receive milestone payments totalling up to US$60.5 million, along with tiered royalties on global net sales of Staccato® alprazolam, in addition to manufacturing revenue from worldwide supply of Staccato® alprazolam. Note: [1] Source of reference: "Acquiring the Staccato® OBT® platform is a transformative step for Lee's Pharm, reinforcing our commitment to innovation in inhalation therapeutics targeting CNS and neurodegenerative disorders, and expanding our global footprint." said Dr. Benjamin Li, Founder and Director of Lee's Pharmaceutical Holdings Limited. "This transaction not only strengthens our pipeline and inhalation R&D capabilities but also creates new revenue streams through the strategic partnerships with UCB." " We are delighted to partner with UCB as it commits and advances solutions to address critical unmet needs in epileptic seizure therapy. This transaction not only delivers near-term financial benefits but also positions us for sustained growth in high-value therapeutic areas, marking a significant milestone in the Company's global expansion strategy." said Ms. Wanee Lee, Managing Director of Lee's Pharmaceutical Holdings Limited. "Under the new leadership, our team is energized to continue collaborating closely with UCB and to ensure the reliable manufacture of meaningful therapy for patients with significant unmet needs. We are equally excited about the opportunity to bring additional Staccato® based medicines to patients around the world, strengthening our shared commitment to improving lives through innovative science." said Dr. Wolfgang Schmidt, SVP Manufacturing and Operations at NPI. About Lee's Pharmaceutical Holdings Limited The Company is a research-driven and market-oriented biopharmaceutical company with more than over 30 years of operation' experience in the pharmaceutical industry in China. The Company is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing based in Mainland China with global perspectives. The Company has established extensive partnerships with around 30 international companies and currently markets over 25 proprietary, generic and licensed-in pharmaceutical products in Mainland China, Hong Kong, Macau and Taiwan. The Company focuses on several key disease therapeutic areas such as cardiovascular health, woman's health, paediatrics, rare diseases, oncology, dermatology and obstetrics. More information available at . About Staccato® One Breath Technology® The Staccato® One Breath Technology® is a unique and highly differentiated drug delivery technology that delivers excipient free drug as fast as intra-venous injection, but non-invasively, resulting in rapid onset of therapeutic effect. It is best positioned for treatment of acute conditions that require quick relief. The ability of the technology with the combination of different molecules to give response to unmet medical needs in an innovative manner has been well proven in large number of clinical studies with different compounds and across number of indications. The proprietary technology is well protected by large numbers of patents across different therapeutic areas. More information available at . 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THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, announced the appointment of James Huang and Nachi Subramanian to its Board of Directors, effective following the completion the Company’s previously announced $16 million offering that was announced on May 15, 2025. The offering closed on May 16, 2025. Mr. Huang has over 37 years of biotech experience and is the Founder and Managing Partner of Panacea Venture. Prior to Panacea Venture, Mr. Huang was a Managing Partner at Kleiner Perkins (KPCB) China where he focused on the firm’s life sciences practice, and a managing partner at Vivo Ventures where he led numerous investments in China. He was also the president of Anesiva, Inc., a biopharmaceutical company focused on pain-management treatments. Earlier in his career, he held senior roles in business development, sales, marketing, and research and development with Tularik Inc. (acquired by Amgen), GlaxoSmithKline LLC, Bristol-Myers Squibb and ALZA Corp. (acquired by Johnson & Johnson). Additionally, Mr. Huang serves as a member of the board of directors of Kindstar Globalgene Technology, Inc., Connect Biopharma Holdings Limited, Lee’s Pharmaceutical Holdings Limited and several private companies. He received an M.B.A. from the Stanford Graduate School of Business and a B.S. degree in chemical engineering from the University of California, Berkeley. Nachi Subramanian has served as a Managing Director at the Redmile Group since December 2021. He previously spent fourteen years at J.P. Morgan, where he held senior roles across the Private Markets and Global Cash Equities businesses. Nachi began his career in Institutional Equities at Bear Stearns. He holds a B.A. in Political Science and Economics from the University of California, Irvine. About Atara Biotherapeutics, Inc. Atara is a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr Virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Atara is headquartered in Southern California. View source version on businesswire.com: https://www.businesswire.com/news/home/20250516069400/en/ Investor and Media Relations Amber Daugherty Sr. Director, Strategy and Operations adaugherty@atarabio.com Source: Atara Biotherapeutics, Inc. Released May 16, 2025

WARRINGTON, Pa., April 15, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the fiscal year ended December 31, 2024 and provided key business updates. “The year 2024 saw Windtree make great progress in many key areas including clinical development of our lead drug candidate istaroxime in cardiogenic shock, business development and the future strategy of the Company,” said Jed Latkin, CEO of Windtree. “Cardiogenic shock is a critical condition with high morbidity and mortality where clinicians express a high need for drug innovation. During the year, we announced positive results of our SEISMiC Extension Phase 2 istaroxime clinical study in early cardiogenic shock (SCAI Stage B) and also began our cardiogenic shock SEISMiC C (SCAI Stage C) Phase 2 study with an interim assessment planned for Q3 2025. In addition, we added a regional licensing partnership with Lee’s Pharmaceutical for greater China.for istaroxime, our preclinical dual mechanism SERCA2a activators and rostafuroxin. We are also continuing discussions with potential partners for our cardiovascular drug candidates.” Mr. Latkin further added, “Importantly, we also announced our new corporate strategy in early 2025 to become a revenue-generating biotech by using Company equity to acquire small biotech companies struggling to maximize the commercial potential of their FDA-approved products. We believe this could be a positive transformation and an opportunity to provide near-term value to our shareholders. As part of our strategy, we are actively evaluating revenue-generating opportunities across various sectors that align with our capabilities and strategic vision.” Mr. Latkin was appointed CEO in December of 2024. He has nearly three decades of financial and biotech experience including prior experience as the CEO of a public biotech company. Mr. Latkin served as the CEO of Navidea Biopharmaceuticals where he started as Chief Financial Officer and executed multiple deals and raised substantial funding. He has also served as CEO of Black Elk Energy Offshore in 2014 as part of Nagel Avenue Capital which he joined after ten years on Wall Street with a variety of investment banking organizations and funds, including ING, Morgan Stanley and Citigroup Securities. Most recently, Mr. Latkin served as the Chief Operating Officer and head of finance at ProPhase Labs, conducting deals and managing broad aspects of the business. Key Business Update Announced positive results from its Phase 2 SEISMiC Extension Study of istaroxime in the treatment of early cardiogenic shock in September 2024.Initiated enrollment in the global SEISMiC C trial evaluating istaroxime in SCAI Stage C cardiogenic shock—a more severely ill population than previously studied—building on positive SEISMiC A and B results; the placebo-controlled, double-blind study will assess istaroxime’s impact on systolic blood pressure and cardiac function alongside standard inotropic/vasopressor therapy, with a planned interim data review in Q3 2025 to inform Phase 3 readiness and regulatory discussions in early 2026.Launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while continuing to progress the Company’s cardiovascular and oncology development pipeline.Entered into a license and supply agreement to become the sourcing partner for Evofem Biosciences, Inc. (OTCQB: EVFM) for PHEXXI® (lactic acid, citric acid and potassium bitartrate), a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. The Company will leverage its manufacturing contacts to reduce pharmaceutical product cost of goods for PHEXXI.Regained Nasdaq compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. The Company will be subject to a mandatory panel monitor until March 20, 2026.Completed istaroxime cardiogenic shock national phase filings of patent applications around the world, including in the U.S., Germany, France, Italy, Japan and China. These filings claimed priority to PCT/US2023/018998 entitled, “Istaroxime-Containing Intravenous Formulation for the Treatment of Pre-Cardiogenic Shock and Cardiogenic Shock”. This application is currently pending before the United States Patent and Trademark Office (USPTO), Application no. 18/858,086. Filed a new PCT patent application for istaroxime and its derivatives targeting the prevention of acute myocardial arrhythmias—building on encouraging data from clinical trials in acute heart failure and early cardiogenic shock, as well as preclinical models showing enhanced efficacy of istaroxime metabolites in improving cardiac function and reducing ischemia-induced arrhythmias.Received a Notice of Allowance from the USPTO for a patent covering an intravenous istaroxime formulation for acute heart failure, and filed a related patent application in India targeting the prevention of life-threatening arrhythmias in heart failure patients—further strengthening the company’s global intellectual property portfolio. Completed national phase filings for the istaroxime patent titled “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF PRE-CARDIOGENIC SHOCK AND CARDIOGENIC SHOCK” (PCT/US2023/018998; U.S. Application No. 18/858,086) in key global markets including the U.S., Germany, France, Italy, Japan, and China—further strengthening international IP protection for its lead cardiovascular asset.Issued Japanese patent (No. 7603605, expiring 2040) for its novel aPKCi inhibitor platform targeting hedgehog pathway-dependent cancers—covering both topical and oral formulations, with potential applications in cancers such as basal cell carcinoma and small cell lung cancer, including use in combination therapies with HDAC inhibitors to enhance anti-cancer efficacy.Seeking to leverage positive Phase 2b results in early cardiogenic shock to secure non-dilutive funding through partnerships for istaroxime and next-generation oral SERCA2a activators outside Greater China; engaged New Growth Advisors to manage inbound interest and lead a broader out-licensing effort, while existing partner Lee’s Pharmaceuticals progresses toward a planned Phase 3 trial in acute heart failure in 1H 2025 under a deal worth up to $138 million in milestones plus royalties.Licensing partner Lee’s Pharmaceutical (HK) Ltd. is preparing to initiate a Phase 3 program for acute heart failure in Greater China, fully funding all development activities in the region; Windtree retains final protocol approval and is collaborating closely with Lee’s as it advances its global cardiogenic shock program in parallel. Select 2024 Year-End Financial Results Research and development (“R&D”) expenses were $16.3 million for the year ended December 31, 2024, compared to $8.3 million for the year ended December 31, 2023. The increase in research and development expenses is primarily due to (i) a $7.5 million charge related to acquired in-process R&D from the Varian asset purchase; and (ii) a $2.2 million increase in costs associated with the continued development of istaroxime, including the SEISMiC Extension study and start-up activities for the SEISMiC C study; partially offset by (iii) a $0.9 million reduction in royalty payments related to amendments to certain license agreements; (iv) a $0.6 million decrease in personnel costs due to headcount reductions; and (v) a $0.3 million decrease in non-cash stock-based compensation expense. General and administrative expenses for the year ended December 31, 2024 were $8.7 million, compared to $9.2 million for the year ended December 31, 2023. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.6 million in non-cash stock-based compensation expense; (ii) a decrease of $0.4 million in personnel costs due to headcount reductions; (iii) a decrease of $0.3 million in severance expense related to a former executive; and (iv) a decrease of $0.4 million in insurance costs; partially offset by (v) an increase of $1.2 million in professional fees, primarily related to increased legal fees and costs associated with the July 2024 private placements. For the year ended December 31, 2024, the Company reported a net loss of $1.8 million, compared to a net loss of $20.3 million for the year ended December 31, 2023. Net loss for the year ended December 31, 2024 includes a $14.4 million non-cash gain on debt extinguishment, a $10.5 million non-cash net gain related to the change in fair value of common stock warrant liability, and a non-cash loss on impairment of goodwill of $1.1 million. Net loss for the year ended December 31, 2023 includes a non-cash loss on impairment of goodwill of $3.1 million. The Company reported a net loss attributable to common stockholders of $5.5 million ($104.35 per basic share) for the year ended December 31, 2024, which includes a deemed dividend of $3.6 million on the Series C Preferred Stock. Net loss attributable to common stockholders was $20.3 million ($4,718.74 per basic share) for the year ended December 31, 2023. As of December 31, 2024, the Company reported cash and cash equivalents of $1.8 million. Subsequent to December 31, 2024, the Company (i) sold an additional 0.2 million shares of common stock under its equity line of credit purchase agreement for net proceeds of $1.5 million following mandatory redemption payments on our Series C preferred stock; (ii) received net proceeds of $0.3 million related to warrant exercises; and (iii) issued certain debt notes for aggregate net proceeds $0.5 million. As a result, the Company believes that it has sufficient resources available to fund its business operations through April 2025. Readers are referred to, and encouraged to read in its entirety, the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which will be filed with the Securities and Exchange Commission on April 15, 2025 and includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations. About Windtree Therapeutics Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase II candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian; risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in Israel and Gaza, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact Information: Eric Curtisecurtis@windtreetx.com WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIESConsolidated Balance Sheets (in thousands, except share and per share data) December 31,2024 December 31,2023 ASSETS Current assets: Cash and cash equivalents $1,779 $4,319 Prepaid expenses and other current assets 795 1,060 Total current assets 2,574 5,379 Property and equipment, net 111 183 Restricted cash 9 150 Operating lease right-of-use assets 1,051 1,444 Intangible assets 24,130 25,250 Total assets $27,875 $32,406 LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $1,879 $809 Accrued expenses 1,706 1,618 Operating lease liabilities - current portion 508 436 ELOC commitment note payable 328 - Derivative liability - ELOC commitment note 299 - Common stock warrant liability 305 - Loans payable - current portion 333 233 Other current liabilities 359 900 Total current liabilities 5,717 3,996 Operating lease liabilities - non-current portion 653 1,161 Restructured debt liability - contingent milestone payments - 15,000 Other liabilities 3,800 3,800 Deferred tax liabilities 4,528 5,058 Total liabilities 14,698 29,015 Mezzanine equity: Series C redeemable preferred stock, $0.001 par value; 18,820 and 0 shares authorized; 11,757 and 0 shares issued and outstanding at December 31, 2024 and 2023, respectively 3,181 - Series B redeemable preferred stock, $0.001 par value; 5,500 and 0 shares authorized; 0 shares issued and outstanding at December 31, 2024 and 2023, respectively - - Total mezzanine equity 3,181 - Stockholders’ equity: Preferred stock, $0.001 par value; 4,975,680 and 5,000,000 shares authorized; 0 shares issued and outstanding at December 31, 2024 and 2023, respectively - - Common stock, $0.001 par value; 120,000,000 shares authorized; 256,397 and 6,664 shares issued and outstanding at December 31, 2024 and 2023, respectively - - Additional paid-in capital 859,660 851,268 Accumulated deficit (846,610) (844,823)Treasury stock (at cost); 1 share (3,054) (3,054)Total stockholders’ equity 9,996 3,391 Total liabilities, mezzanine equity & stockholders’ equity $27,875 $32,406 WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Statements of Operations (in thousands, except share and per share data) Year Ended December 31, 2024 2023 Expenses: Research and development $16,276 $8,341 General and administrative 8,743 9,198 Impairment of goodwill - 3,058 Impairment of intangible assets 1,120 - Total operating expenses 26,139 20,597 Operating loss (26,139) (20,597) Other (expense) income: Gain on debt extinguishment 14,437 - Change in fair value of common stock warrant liability 10,482 - Interest income 70 325 Interest expense (235) (50)Other (expense) income, net (408) 31 Total other income, net 24,346 306 Loss before income taxes (1,793) (20,291)Deferred income tax benefit 6 - Net loss $(1,787) $(20,291)Exchange of Series B preferred stock (79) - Deemed dividend on Series C preferred stock (3,621) - Net loss attributable to common stockholders $(5,487) $(20,291) Net loss per share attributable to common stockholders Basic and diluted $(104.35) $(4,718.84) Weighted average number of common shares outstanding Basic and diluted 52,583 4,300