Fulvestrant

The FDA said Friday that it approved Pfizer and Arvinas' oral PROTAC selective oestrogen receptor degrader (SERD) Veppanu (vepdegestrant; ARV-471) for a genetically defined subset of breast cancer patients, even as the companies a few months ago stepped back from plans to bring the therapy to market themselves.The once-daily drug is specifically indicated for ER-positive, HER2-negative, advanced or metastatic disease in adults carrying ESR1 mutations and who have progressed after at least one line of endocrine therapy.The regulatory filing was approved based on the Phase III VERITAC-2 trial, which enrolled 624 breast cancer patients previously treated with CDK 4/6 inhibitors and endocrine therapy. Among 270 patients whose tumours carried ESR1 mutations, median progression-free survival (PFS) was 5 months with Veppanu versus 2.1 months for the fulvestrant comparator, reflecting a 43% benefit. Objective response rates were 19% and 4% for the two arms, respectively.However, the PFS benefit was confined to the ESR1-mutant subgroup. In the broader study population, which included patients with wild type ESR1, Veppanu failed to show a statistically significant improvement.The FDA noted Friday that overall survival data are still immature, with deaths reported in 16% of the ESR1-mutant cohort at the time of the PFS analysis.Safety findings included risks of QTc interval prolongation and embryo-foetal toxicity, according to the FDA label.Arvinas and Pfizer linked up in 2021, with Pfizer paying $650 million upfront to co-develop and co-commercialise the drug. But after the mixed VERITAC-2 readout, the partners signalled last September that they would back away from directly selling the medicine and seek a third-party commercial partner instead. Arvinas also further trimmed its headcount at the time, with most of the layoffs connected to the planned commercial push for Veppanu.The drug will compete against Eli Lilly's oral SERD Inluriyo (imlunestrant), which the FDA approved last year in the same indication based on Phase III data from the EMBER-3 trial where it was found to reduce the risk of progression or death by 38%.Another likely rival is Roche's SERD candidate giredestrant, which has succeeded in a pair of Phase III trials — evERA and lidERA — involving similar patient populations (see – Spotlight On: Roche confirms giredestrant PDUFA, albeit in narrower second-line setting).Meanwhile, an FDA advisory panel voted down AstraZeneca's SERD contender this week. Panel members said they weren't convinced that the Phase III SERENA-6 study of camizestrant proved that early biomarker-based switching to the drug improved long-term survival rates in HR-positive/HER2-negative metastatic breast cancer patients (see – Spotlight On: First-line and adjuvant opportunities still beckon for AstraZeneca's camizestrant despite FDA setback).

TAIPEI, Taiwan, April 30, 2026 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced its financial results for the full year ended December 31, 2025. Management Commentary “2025 was a highly transformative and foundational year for YD Bio, characterized by the successful capitalization of our long-term strategic vision. The successful completion of our business combination with Breeze Holdings Acquisition Corp. in August 2025, alongside a $13.2 million private investment in public equity (PIPE) financing, helped to significantly strengthen our balance sheet. Furthermore, we achieved a 17% increase in net revenue, driven predominantly by expanded pharmaceutical sales volumes and strategic new product launches,” said Dr. Ethan Shen, Chairman and CEO of YD Bio. “We ended the year well-capitalized with approximately $6.0 million in cash and cash equivalents, which we believe positions us to securely meet our operating obligations in 2026 and aggressively pursue our clinical milestones.” “During the past year, we consciously increased our research and development expenditures by approximately $1.1 million to secure essential licensed patents and technological know-how, and we restructured our sales mix to rapidly scale our commercial footprint. These foundational investments in our clinical service infrastructure and diagnostics platform are designed to support robust growth across multiple regulated healthcare segments.” “Looking ahead, our strategic focus for 2026 is to aggressively advance our proprietary assets from validation toward expanded regulatory and commercial execution. We have already achieved certain milestones in our therapeutics pipeline by completing comprehensive Chemistry, Manufacturing, and Controls (CMC) development and filing Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA) for our Limbal Stem Cell (LSC) platform and derived exosome products. This paves the way for us to submit Investigational New Drug (IND) applications to the FDA for both Dry Eye Disease and Age-Related Macular Degeneration in 2026. Concurrently, we are advancing our OkaiDx™ Pancreatic Cancer Early Detection Program toward an FDA Q-Submission to discuss potential Breakthrough Device eligibility and building upon our EG Telehealth Platform, which was recently launched in March 2026 to support diagnostic service delivery across the United States.” “Finally, our vision to become an integrated, multi-vertical healthcare platform is being aggressively pursued through strategic M&A activity. For example, the previously announced merger with EG BioMed aims to seamlessly integrate DNA methylation-driven artificial intelligence platforms into our oncology programs,” said Dr. Shen. YD Bio's Full Year 2025 Financial Results Through the Company’s combined diagnostics platform, clinical service infrastructure, and healthcare commercialization capabilities, YD Bio seeks to develop a scalable operating model designed to support growth across multiple regulated healthcare segments. The following table presents selected summarized financial information taken from YD Bio’s consolidated statements of operations for the year ended December 31, 2025 and 2024. In thousands USD, except percentage data, differences due to rounding For the years ended December 31, 2025 2024 Variance % Net Revenue $ 597 510 17 % Cost of Revenue (429 ) (355 ) 21 % Gross Profit 168 155 8 % General and Administrative Expenses 3,663 1,125 226 % Selling and Marketing Expenses 171 2 8,450 % Research and Development Expenses 1,602 491 226 % Impairment of expected credit loss 3 (1 ) 400 % Total Operating Expenses 5,439 1,617 236 % Loss from Operations (5,271 ) (1,462 ) 261 % Net Loss (8,310 ) (1,412 ) 489 % Net Revenue Net revenue increased by $86,457 or 17% to $596,817 for the year ended December 31, 2025, compared to $510,360 for the year ended December 31, 2024. The top 5 individual products by revenue accounted for 41% of the total revenue during the period. The increase in revenue was primarily due to higher sales volumes and a shift in product mix toward lower-priced products, as reflected in the decrease in average selling price. Pharmaceutical sales, particularly Keytruda, which increased by approximately $48,598 driven by higher purchase volumes from key customers, along with new product launches, were the primary growth drivers. This growth was partially offset by decreased medical product sales, primarily due to the discontinuation of certain products and reduced orders for PVA eye cleansing tablets as a key customer adjusted its procurement strategy based on end-market feedback. Overall, the revenue change reflects a structural shift from higher-priced medical products toward pharmaceuticals and other lower-priced offerings. Top five individual products by revenue for the year ended December 31, 2025: Product Revenue Keytruda Injection (Drugs) $ 133,138 HQ Revitalizing and Renewing Tencel Mask (Beauty Products) 36,749 Exolens Hioxifilcon (Contact lenses) 35,000 Mounjaro Pen (Drugs) 22,025 12-Lead Electrocardiograph (Medical and related products) 20,416 Subtotal $ 247,328 Top five individual products by revenue for the year ended December 31, 2024: Product Revenue PVA Eye Cleansing Wipes (Medical and related products) $ 97,512 Keytruda injection (Drugs) 84,540 Immune Defense Proteins (Nutritional products) 33,613 Fluorescence Cell Counter and Viability Analyzer (Medical and related products) 23,177 Faslodex solution for injection (Drugs) 21,127 Subtotal $ 259,969 Cost of Revenue Cost of revenue increased by $74,403 or 21% to $429,407 for the year ended December 31, 2025, compared to $355,004 for the year ended December 31, 2024. The cost of revenue consists primarily of purchase costs of products for resales. The increase in cost of revenue was higher than the increase of net revenue, which was primarily due to the change in sales mix to the products sold with a lower margin during the year. Specifically, the sales mix shifted from higher-margin medical products to drugs and medical peripherals with relatively lower margins, resulting in a decrease in overall gross margin. This impact was partially offset by lower procurement costs for certain products. Gross Profit Gross profit increased by $12,054 or 8% to $167,410 for the year ended December 31, 2025, compared to $155,356 for the year ended December 31, 2024. The year-to-year changes were primarily due to higher sales volumes and a shift in product mix toward lower-priced products. Operating Expenses For the year ended December 31, 2025, the Company’s total operating expenses were approximately $5.4 million, reflecting an increase of $3.8 million compared to $1.6 million for the year ended December 31, 2024. The increase was mainly caused by the increase in professional and consultancy service fees related to the Company’s expansion and restructuring costs of $1.1 million, the increase in research and development expenses by $1.1 million related to two licensed patents and know-how, and by the $1.3 million increase in staff costs from the expansion of the Company’s business. Net Loss As a result of the foregoing, net loss for the year ended December 31, 2025 was $8.3 million compared to $1.4 million for the year ended December 31, 2024. The increase in net loss was mainly caused by the increase of change in fair value of warrant liabilities by $3.2 million, professional and consultancy service fees related to the Company expansion and restructuring by $1.1 million, research and development expenses by $1.1 million related to two licensed patents and know-how, and by the $1.3 million increase in staff costs from the expansion of the Company’s business. Cash and Cash Equivalents As of December 31, 2025, YD Bio’s cash was $6.0 million compared to $3.1 million as of December 31, 2024. This increase was primarily due to an equity raise of $13.9 million, offset by deferred offering cost of approximately $3.2 million, professional and consultancy services fees related to the Company expansion and restructuring of $1.5 million, research and development expenses of $1.1 million, payment for purchase of medical products and contact lenses of $1.9 million and prepayment for the purchase of office space and parking facilities of $1.5 million. YD Bio Major Developments and 2026 Outlook Therapeutics and Limbal Stem Cell Platform Completed comprehensive Chemistry, Manufacturing, and Controls development for the Limbal Stem Cell platform and its derived exosome products. Filed Drug Master Files with the FDA for both Limbal Stem Cells and derived exosomes. Planning to establish a clinical-grade Limbal Stem Cell bank and submit an Investigational New Drug application for Dry Eye Disease in 2026. Expecting to complete preclinical, efficacy, and toxicity studies for Age-Related Macular Degeneration, followed by an Investigational New Drug submission in 2026. Diagnostics and Telehealth Operating the online EG Telehealth Platform offering CLIA- and CAP-certified laboratory services across 44 U.S. states, Washington D.C., and Guam. Advancing the OkaiDx™ Pancreatic Cancer Early Detection Program through a clinical validation pathway aligned with the FDA. Aiming to complete patient enrollment, data cleaning, quality control, and preliminary statistical analysis for the OkaiDx™ program in 2026. Planning a Q-Submission to the FDA to discuss potential Breakthrough Device eligibility for the pancreatic cancer program. Strategic Expansions and Acquisitions Announced a non-binding Memorandum of Understanding on January 6, 2026, to merge with EG BioMed. Announced a binding Letter of Intent on January 20, 2026, to acquire Safe Save Medical Cell Sciences & Technology Co., Ltd. Announced a Master Strategic Alliance Agreement by and between YD Bio USA, Inc. and YC Biotech Co., Ltd. On February 25, 2026. About YD Bio Limited YD Bio is a U.S.-anchored public biotechnology company building an integrated healthcare platform across regulated diagnostics, clinical services, and commercial healthcare markets. The Company operates DNA methylation–based oncology testing programs in the United States under an LDT-first strategy and provides compliant life science distribution and clinical trial supply chain services to pharmaceutical and biotechnology partners. In addition, the Company maintains regulated ocular health commercialization operations and a consumer health distribution platform in Asia. Through strategic partnerships and scalable execution capabilities, the Company aims to advance biomedical innovation with real-world clinical and commercial impact. For more information, visit ir.ydesgroup.com and follow the Company on Facebook, X, Threads, Instagram and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, among others, statements about the Company’s strategy, ongoing transactions, and expected commercialization and regulatory timelines. Forward-looking statements are based on current expectations, estimates, forecasts, and projections and are not guarantees of future performance. Investors can identify these forward-looking statements by words or phrases such as “aim,” “target,” “approximates,” “believes,” “designed to,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Actual results may differ materially due to a variety of factors, including regulatory decisions and feedback, the ability to consummate certain transactions and achieve their anticipated benefits, and other risks and uncertainties described in YD Bio’s filings with the U.S. Securities and Exchange Commission (the “SEC”). The Company undertakes no obligation to update any forward-looking statements, except as required by law. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s Annual Report on Form 20-F, registration statement and other filings with the SEC. For investor and media inquiries, please contact: YD Bio Limited Investor Relations Email: investor@ydesgroup.com WFS Investor Relations Inc. Email: services@wfsir.com Phone: +1 628 283 9214 YD BIO LIMITED CONSOLIDATED BALANCE SHEETS As of December 31, 2025 As of December 31, 2024 US$ US$ ASSETS CURRENT ASSETS Cash and cash equivalents 6,007,615 3,132,298 Accounts receivable, net 167,477 86,582 Other receivables from an affiliate, net 291,540 16,927 Inventories 1,879,542 37,335 Prepaid expenses and other current assets 1,324,016 194,740 TOTAL CURRENT ASSETS 9,670,190 3,467,882 Operating lease right-of-use assets, net 8,470 23,698 Property, plant and equipment, net 59,340 64,379 Intangible assets 2,609,739 2,680,035 Deferred offering costs - 628,232 Prepaid expenses, non-current 1,431,658 - TOTAL ASSETS 13,779,397 6,864,226 LIABILITIES CURRENT LIABILITIES Due to affiliates 785,665 37,253 Operating lease liabilities, current 6,764 16,581 Accounts payable 413,290 26,866 Accrued expenses and other liabilities 437,859 182,360 TOTAL CURRENT LIABILITIES 1,643,578 263,060 Deferred tax liabilities — 1,463 Operating lease liabilities, non-current — 5,684 Accrued expenses and other liabilities, non-current — 3,773 Warrant Liabilities 14,991,482 — TOTAL LIABILITIES 16,635,060 273,980 Commitments and contingencies SHAREHOLDERS’ EQUITY (DEFICIT) Common shares ($0.0001 par value, 500,000,000 shares authorized; 70,789,261 and 64,730,411 issued and outstanding as of December 31, 2025 and 2024, respectively)* 7,079 6,473 Additional paid-in capital* 7,161,681 8,465,744 Accumulated deficits (10,238,359 ) (1,927,043 ) Accumulated other comprehensive income 213,936 45,072 Total shareholders’ equity (deficit) (2,855,663 ) 6,590,246 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT) 13,779,397 6,864,226 YD BIO LIMITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME/(LOSS) Years ended December 31, 2025 2024 2023 US$ US$ US$ Revenue 596,817 510,360 350,131 Cost of revenue (429,407 ) (355,004 ) (196,686 ) Gross profit 167,410 155,356 153,445 Operating expenses General and administrative expenses 3,663,141 1,124,469 153,069 Selling and marketing expenses 170,523 1,957 7,492 Research and development expenses 1,602,064 491,353 — Impairment (Recovery) of expected credit loss 3,403 (493 ) 2,731 Total operating expenses 5,439,131 1,617,286 163,292 Loss from operations (5,271,721 ) (1,461,930 ) (9,847 ) Other income (expense) Other income, net 46,803 64,415 29,351 Interest income 80,162 11,808 290 Interest expenses — (772 ) (2,144 ) Change in fair value of warrant liabilities (3,168,091 ) — — Total other income (expense), net (3,041,126 ) 75,451 27,497 (Loss) Income before income tax (8,312,847 ) (1,386,479 ) 17,650 Income tax 1,531 (25,080 ) (4,090 ) Net (loss) income (8,311,316 ) (1,411,559 ) 13,560 Other comprehensive (loss) income, net of tax: Change in foreign currency translation adjustments 168,864 (2,139 ) 99 Other Comprehensive (loss) income (8,142,452 ) (1,413,698 ) 13,659 Basic and diluted net (loss) income per share (0.12 ) (0.02 ) 0.0002 Basic and diluted weighted average number of shares outstanding 66,719,177 64,730,411 64,730,411