Pembrolizumab

Reports second quarter revenue of $0.1 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(1.97) Reiterates plan to deliver up to 10% revenue growth in 2026 Improves 2026 GAAP operating expense outlook by approximately $0.2 billion from previous estimate and improves expected 2026 year-end cash balance to $4.7 - 5.2 billion Anticipates potential approval of Moderna's fifth product with the August 5th PDUFA date for mFLUSIVA, the Company's seasonal influenza vaccine candidate ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Announces that mRNA-1403, Moderna's norovirus vaccine candidate, did not meet statistical criteria for early success at the Phase 3 interim analysis and the Company is preparing to enroll an additional cohort CAMBRIDGE, MA / ACCESS Newswire / July 31, 2026 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the second quarter of 2026. "The second quarter marked another period of strong execution for Moderna as we advanced our pipeline and strengthened our financial pro an improved 2026 operating expense outlook," said Stéphane Bancel, Chief Executive Officer of Moderna. "In the second half of 2026, we are preparing for the potential approval of mFLUSIVA in the U.S., which would be our fifth approved product, and continue to anticipate important pivotal readouts for our intismeran in melanoma and propionic acidemia programs." Commercial Updates During the second quarter, Moderna continued to advance its multi-year revenue growth strategy by executing on strategic partnerships and key approvals. In Brazil, a collaboration was signed with a local manufacturer in support of a supply agreement for COVID vaccines. In the EU, the Company signed a joint procurement contract with the European Commission on behalf of six countries for up to 24 million doses of mRESVIA ® . Moderna also received regulatory approvals in Australia and Mexico for mRESVIA and in Japan and Taiwan for mNEXSPIKE ® , and its investigational seasonal influenza vaccine, mFLUSIVA®, received a unanimous recommendation from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) ahead of an August 5 Prescription Drug User Fee Act (PDUFA) goal date in the U.S. Second Quarter 2026 Financial Results Revenue : Total revenue for the second quarter of 2026 was $145 million, compared to $142 million in the same period in 2025. Lower COVID vaccine sales in the U.S. and South America were offset by deliveries in the United Kingdom under a long-term strategic government partnership and higher stand-ready manufacturing and collaboration revenue. Revenue was $87 million in the U.S. and $58 million in international markets. Cost of Sales: Cost of sales for the second quarter of 2026 was $93 million, including $41 million of inventory write-downs, $23 million of unutilized manufacturing capacity costs, and $11 million of third-party royalties. Cost of sales decreased by 22% compared to the same period in 2025, primarily reflecting lower unutilized manufacturing capacity costs resulting from continued manufacturing productivity improvements and operational efficiencies. Research and Development Expenses: Research and development expenses for the second quarter of 2026 were $651 million, a 7% decrease compared to the same period in 2025. The decrease was primarily driven by lower clinical development costs following the wind-down of several late-stage programs. Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of 2026 were $216 million, a 6% decrease compared to the same period in 2025. The decrease reflected continued discipline across the organization. Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets. Net Loss: Net loss was $(0.8) billion for the second quarter of 2026, an improvement of $43 million, or 5%, compared to the second quarter of 2025. Loss Per Share: Loss per share was $(1.97) for the second quarter of 2026, compared to loss per share of $(2.13) for the second quarter of 2025. Cash Position: Cash, cash equivalents and investments as of June 30, 2026, were $6.9 billion, compared to $7.5 billion as of March 31, 2026. The decrease primarily reflected cash used to fund operations, continued investment in research and development and advancement of the Company's pipeline. The Company subsequently paid $950 million in July 2026 related to the litigation settlement announced in the first quarter of 2026. 2026 Financial Framework Revenue: The Company is targeting up to 10% growth from 2025 revenue and expects 2026 revenue split to be approximately 50% U.S. and approximately 50% international. Moderna expects approximately 55% of its second half 2026 revenue to be recognized in the third quarter. Cost of Sales: Cost of sales for 2026 is expected to be approximately $1.7 billion, lowered from approximately $1.8 billion, and including the $0.9 billion non-recurring litigation settlement charge. Research and Development Expenses: Research and development expenses for 2026 are now anticipated to be approximately $2.9 billion, lowered from approximately $3.0 billion. Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2026 are projected to be approximately $1.0 billion. Income Taxes: The Company expects its full-year tax expense to be negligible. Capital Expenditures: Capital expenditures for 2026 are expected to be $0.2 to $0.3 billion. Cash and Investments: Year-end cash and investments for 2026 are now projected to be $4.7 to $5.2 billion, an improvement of approximately $0.2 billion. This excludes any further drawdowns from the Company's remaining $0.9 billion available under its credit facility. Recent Progress and Upcoming Late-Stage Pipeline Milestones Infectious disease vaccines: Seasonal flu + COVID vaccine : Moderna has received European Commission marketing authorization for mCOMBRIAX in the EU and its mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. The Company is awaiting further guidance from the U.S. FDA on refiling the submission for its flu plus COVID combination vaccine. Seasonal flu vaccine : The Company's mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in 2026. The U.S. FDA has assigned a PDUFA date for mRNA-1010 of August 5, 2026 Norovirus vaccine : Moderna's Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim analysis. The trial is ongoing and remains blinded as the Company works toward enrolling an additional cohort. Oncology therapeutics: Intismeran autogene : The Company is advancing mRNA-4157 in collaboration with Merck, with nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC announced last quarter. Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. Moderna expects Phase 3 adjuvant melanoma data potentially in 2026. The Company recently presented positive five-year Phase 2b adjuvant melanoma data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone. mRNA-4359 : Moderna's Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC. Rare disease therapeutics: Propionic acidemia (PA) therapeutic : The Company's PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects potential data in 2026. Methylmalonic acidemia (MMA) therapeutic : The Company deferred its decision on a pivotal trial for mRNA-3705 until PA registrational data readout. Moderna Corporate Updates Appointed Ester Banque to Chief Commercial Officer of Moderna, effective June 15, 2026. Appointed Michael McDonnell, former Chief Financial Officer of Biogen, to Moderna's Board of Directors, effective July 8, 2026. Company Accolades Moderna was ranked no. 1 by TIME on its list of the World's Most Impactful Companies. Key 2026 Investor and Analyst Event Dates Analyst Day: November 12 Investor Call and Webcast Information Moderna will host a live conference call and webcast at 8:00 a.m. ET on July 31, 2026. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website. Telephone: Webcast: The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call. About Moderna Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. MODERNA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited, in millions, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenue: Net product sales $ 94 $ 114 $ 446 $ 200 Other revenue 1 51 28 88 50 Total revenue 145 142 534 250 Operating expenses: Cost of sales 93 119 1,048 209 Research and development 651 700 1,300 1,556 Selling, general and administrative 216 230 389 442 Total operating expenses 960 1,049 2,737 2,207 Loss from operations (815 ) (907 ) (2,203 ) (1,957 ) Interest income 67 81 139 171 Other (expense) income, net (19 ) 8 (37 ) 4 Loss before income taxes (767 ) (818 ) (2,101 ) (1,782 ) Provision for income taxes 15 7 24 14 Net loss $ (782 ) $ (825 ) $ (2,125 ) $ (1,796 ) Net loss per share Basic and Diluted $ (1.97 ) $ (2.13 ) $ (5.36 ) $ (4.64 ) Weighted average common shares used in calculation of net loss per share Basic and Diluted 398 388 396 387 1 Includes grant, collaboration, licensing and royalty, and stand-ready manufacturing revenue. MODERNA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in millions) June 30, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 1,723 $ 2,595 Investments 3,415 3,204 Accounts receivable, net 17 184 Inventory 280 153 Prepaid expenses and other current assets 380 408 Total current assets 5,815 6,544 Investments, non-current 1,772 2,336 Property, plant and equipment, net 2,059 2,134 Right-of-use assets, operating leases 697 719 Other non-current assets 618 605 Total assets $ 10,961 $ 12,338 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 167 $ 317 Accrued liabilities 1,909 1,386 Deferred revenue 295 99 Other current liabilities 163 185 Total current liabilities 2,534 1,987 Deferred revenue, non-current 147 153 Operating lease liabilities, non-current 638 653 Financing lease liabilities, non-current 6 20 Long-term debt 591 590 Other non-current liabilities 284 285 Total liabilities 4,200 3,688 Stockholders' equity: Additional paid-in capital 1,644 1,382 Accumulated other comprehensive income 19 45 Retained earnings 5,098 7,223 Total stockholders' equity 6,761 8,650 Total liabilities and stockholders' equity $ 10,961 $ 12,338 MODERNA, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited, in millions) Six Months Ended June 30, 2026 2025 Operating activities Net loss $ (2,125 ) $ (1,796 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 224 245 Depreciation and amortization 122 96 Amortization/accretion of investments (21 ) (37 ) Loss on equity investments, net 2 8 Other non-cash items 10 36 Changes in assets and liabilities: Accounts receivable, net 167 310 Prepaid expenses and other assets 70 (150 ) Inventory (126 ) (122 ) Right-of-use assets, operating leases 21 19 Accounts payable (128 ) (203 ) Accrued liabilities 475 (395 ) Deferred revenue 195 68 Operating lease liabilities (15 ) (10 ) Other liabilities (27 ) (25 ) Net cash used in operating activities (1,156 ) (1,956 ) Investing activities Purchases of marketable securities (1,904 ) (3,059 ) Proceeds from maturities of marketable securities 1,442 3,424 Proceeds from sales of marketable securities 814 1,059 Purchases of property, plant and equipment (99 ) (120 ) Purchase of intangible asset - (10 ) Net cash (used in) provided by investing activities 253 1,294 Financing activities Proceeds from issuance of common stock through equity plans 42 17 Tax payments related to net share settlements on equity awards (4 ) (1 ) Changes in financing lease liabilities (7 ) (3 ) Net cash provided by financing activities 31 13 Effect of changes in exchange rates on cash and cash equivalents (1 ) 1 Net decrease in cash, cash equivalents and restricted cash (873 ) (648 ) Cash, cash equivalents and restricted cash, beginning of year 2,597 1,929 Cash, cash equivalents and restricted cash, end of period $ 1,724 $ 1,281 Spikevax ® , mRESVIA ® , mNEXSPIKE ® , mCOMBRIAX ® and mFLUSIVA ® are registered trademarks of Moderna. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's 2026 financial framework, including its plan to deliver up to 10% revenue growth and GAAP operating expense reductions, and its projected year-end cash balance; Moderna's multi-year revenue growth strategy, including geographic expansion and new product approvals; Moderna's continued cost discipline; Moderna's international strategic partnerships; expectations regarding mRNA-4157 Phase 3 adjuvant melanoma data in 2026; the potential of intismeran as monotherapy and in combination with KEYTRUDA QLEX; the potential of Moderna's oncology portfolio; pending and anticipated regulatory filings and potential approvals, including timing of approvals; Moderna's PDUFA date in the U.S. for mRNA-1010 and the potential product approval of mFLUSIVA; enrollment of an additional cohort for mRNA-1403; and anticipated progress and milestones for Moderna's pipeline programs, including potential near-term data and other catalysts. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. ### Moderna Contacts Media: Chris Ridley Vice President, Head of Global Communications +1 617-800-3651 Chris.Ridley@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire

CHENGDU, China, July 30, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that a new indication application of its trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the first-line treatment of patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have a programmed death ligand 1 (PD-L1) combined positive score (CPS) <10, or have recurred after prior programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy in the early stage. This marks the sixth indication application accepted by the NMPA for sac-TMT. The acceptance for review is based on the positive results from the randomized, open-label, multicenter Phase III registrational OptiTROP-Breast03 study evaluating the efficacy and safety of sac-TMT versus investigator's choice of chemotherapy in patients with unresectable recurrent or metastatic TNBC who have not received prior systemic therapy for advanced disease. The enrolled population included patients with PD-L1 CPS <10, as well as those who have recurred after prior PD-1/PD-L1 inhibitor therapy in the early stage. The study demonstrated that sac-TMT achieved statistically significant and clinically meaningful improvements in key efficacy profile compared with investigator's choice of chemotherapy, showing a clear clinical benefit. Previously, sac-TMT was granted Breakthrough Therapy Designation (BTD) by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1-negative TNBC. This new indication application has also been included in the priority review and approval process, becoming the sixth application for sac-TMT to enter this process. Inclusion in this process is expected to further expedite the review and approval, allowing this innovative treatment to benefit patients sooner. Dr. Michael Ge, CEO of Kelun-Biotech, said, "Following the approval of sac-TMT for second-line or later treatment of TNBC based on results from the Phase III OptiTROP-Breast01 study, we are delighted to see another important milestone in the same disease area. For patients with PD-L1-negative advanced TNBC, the efficacy of traditional chemotherapy is limited, and there is an urgent clinical need for more effective and safer first-line treatment options. The positive results from the OptiTROP-Breast03 study demonstrate a clear and clinically meaningful improvement in efficacy with sac-TMT compared to chemotherapy and support the continued evaluation of sac-TMT as the first-line treatment for TNBC. We look forward to the early approval of this indication to bring a new and more effective first‑line treatment option to a broader population with advanced TNBC." About sac-TMT( 佳泰莱® ) Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan). To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six BTDs by the NMPA. Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. Two new indication applications have been accepted for review by the NMPA and have been included in the priority review and approval process: 1) sac-TMT in combination with pembrolizumab (KEYTRUDA®[1]) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 tumor proportion score (TPS)≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative; and 2) sac‑TMT as first‑line treatment for patients with recurrent or metastatic TNBC who have a PD‑L1 CPS <10 or have recurred after prior PD‑1/PD‑L1 inhibitor therapy in the early stage. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 2 projects with 3 indications are in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit . SOURCE Kelun-Biotech 21% more press release views with Request a Demo