Gemcitabine Hydrochloride

BAAR, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) today reported financial results for the third quarter that ended September 30, 2025. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). “Q3 was a solid quarter with steady commercial execution in glioblastoma, geographic expansion, and material progress for our clinical and product development pipelines,” said Ashley Cordova, CEO, Novocure. “With four indications expected in market by year-end 2026, we are well on our way to becoming a platform therapy company — and we remain sharply focused on reaching profitability and expanding patient impact.” Financial updates for the third quarter ended September 30, 2025: Total net revenues for the quarter were $167.2 million, an increase of 8% compared to the same period in 2024. This increase was primarily driven by active patient growth, as well as $3.3 million in exchange rate benefits. The U.S., Germany, France and Japan contributed $96.6 million, $20.3 million, $19.6 million and $9.4 million, respectively, with other active markets contributing $15.7 million. Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.6 million. Recognized revenue from Optune Lua ® in the quarter was $3.1 million, including $1.6 million from non-small cell lung cancer (NSCLC) and $1.5 million from malignant pleural mesothelioma (MPM). The U.S., Germany, France and Japan contributed $96.6 million, $20.3 million, $19.6 million and $9.4 million, respectively, with other active markets contributing $15.7 million. Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.6 million. Recognized revenue from Optune Lua ® in the quarter was $3.1 million, including $1.6 million from non-small cell lung cancer (NSCLC) and $1.5 million from malignant pleural mesothelioma (MPM). Gross margin for the quarter was 73% compared to 77% in the prior year. The reduction was primarily driven by the continued roll out of our Head Flexible Electrode (HFE) transducer array for use with Optune Gio ® , costs associated with treating NSCLC patients prior to establishing broad reimbursement, and increased tariffs. Additionally, this quarter Novocure recognized a $2.9 million expense related to an inventory obsolescence provision for Optune Lua arrays. Research, development and clinical study expenses for the quarter were $54.0 million, an increase of 4% from the same period in 2024. This was primarily driven by increased product development costs and increased regulatory expenses related to the premarket approval (PMA) applications for the use of TTFields therapy in the treatment of locally advanced pancreatic cancer and brain metastases from NSCLC. Sales and marketing expenses for the quarter were $58.5 million, a decrease of 2% compared to the same period in 2024. This was primarily driven by lower share-based compensation expenses. General and administrative expenses for the quarter were $45.9 million, an increase of 15% compared to the same period in 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional services expenses to support the greater company build-out, particularly in enterprise technology as we invest in our digital infrastructure to enable scale. Net loss for the quarter was $37.3 million with loss per share of $0.33. Adjusted EBITDA* for the quarter was $(3.0) million. Cash, cash equivalents and short-term investments were $1,033.5 million as of September 30, 2025. Operational updates for the third quarter ended September 30, 2025: As of September 30, 2025, there were 4,416 total active patients on TTFields therapy globally. Optune Gio 1,675 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, an increase of 7% from the same period in 2024. The U.S., Germany, France and Japan contributed 954; 227; 191 and 130 prescriptions, respectively, with the remaining 173 prescriptions contributed by other active markets. As of September 30, 2025, there were 4,277 Optune Gio active patients on therapy, an increase of 5% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,176; 595; 499 and 474 Optune Gio active patients, respectively, with the remaining 533 active patients contributed by other active markets. 1,675 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, an increase of 7% from the same period in 2024. The U.S., Germany, France and Japan contributed 954; 227; 191 and 130 prescriptions, respectively, with the remaining 173 prescriptions contributed by other active markets. As of September 30, 2025, there were 4,277 Optune Gio active patients on therapy, an increase of 5% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,176; 595; 499 and 474 Optune Gio active patients, respectively, with the remaining 533 active patients contributed by other active markets. Optune Lua 130 total prescriptions for Optune Lua were received in the quarter. 109 Optune Lua prescriptions were received for the treatment of NSCLC and 21 prescriptions were received for the treatment of MPM. As of September 30, 2025, there were 139 active Optune Lua patients on therapy, including 100 patients treated for metastatic NSCLC and 39 patients treated for MPM. 130 total prescriptions for Optune Lua were received in the quarter. 109 Optune Lua prescriptions were received for the treatment of NSCLC and 21 prescriptions were received for the treatment of MPM. As of September 30, 2025, there were 139 active Optune Lua patients on therapy, including 100 patients treated for metastatic NSCLC and 39 patients treated for MPM. Quarterly updates and achievements: In August 2025, Novocure’s PMA application to the U.S. Food and Drug Administration (FDA) for the use of TTFields therapy for the treatment of locally advanced pancreatic cancer was accepted for filing. This submission is supported by data from the Phase 3 PANOVA-3 trial, which evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for adults with unresectable, locally advanced pancreatic cancer. In August 2025, Novocure announced the coverage of Optune Gio through the Spanish National Health System for the treatment of adult patients with newly diagnosed glioblastoma In September 2025, Novocure received approval for Optune Lua use concurrently with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced/recurrent NSCLC who progressed on or after platinum-based chemotherapy from the Japanese Ministry of Health, Labour and Welfare. Anticipated clinical and regulatory milestones: Novocure intends to submit a PMA application to the FDA for the treatment of brain metastases from NSCLC based on results of the Phase 3 METIS clinical trial in Q4 2025. The topline data readout from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer is expected in Q1 2026. The topline data readout from the Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma is expected in Q2 2026. Conference call details Novocure will host a conference call and webcast to discuss third quarter 2025 financial results at 8:00 a.m. EDT today, Thursday, October 30, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link. The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. About Novocure Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure’s global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and X (Twitter). *Non-GAAP Financial Measurements We measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation. Forward-Looking Statements In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 27, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) Three months ended September 30, Nine months ended September 30, Year ended December 31, 2025 2024 2025 2024 2024 Unaudited Unaudited Audited Net revenues $ 167,204 $ 155,095 $ 481,003 $ 443,954 $ 605,220 Cost of revenues 44,729 35,372 124,722 103,715 137,181 Gross profit 122,475 119,723 356,281 340,239 468,039 Operating costs and expenses: Research, development and clinical studies 54,029 51,882 163,639 158,435 209,645 Sales and marketing 58,546 59,830 171,404 171,652 239,063 General and administrative 45,921 40,103 134,645 117,344 189,827 Total operating costs and expenses 158,496 151,815 469,688 447,431 638,535 Operating income (loss) (36,021 ) (32,092 ) (113,407 ) (107,192 ) (170,496 ) Financial income (expenses), net 5,999 10,507 18,111 31,236 39,334 Income (loss) before income tax (30,022 ) (21,585 ) (95,296 ) (75,956 ) (131,162 ) Income tax 7,248 8,985 16,432 26,749 37,465 Net income (loss) $ (37,270 ) $ (30,570 ) $ (111,728 ) $ (102,705 ) $ (168,627 ) Basic and diluted net income (loss) per ordinary share $ (0.33 ) $ (0.28 ) $ (1.00 ) $ (0.95 ) $ (1.56 ) Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share 111,908,252 108,247,716 111,259,532 107,679,501 107,834,368 Consolidated Balance Sheets USD in thousands (except share data) NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (except share data) September 30, 2025 December 31, 2024 Unaudited Audited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 342,119 $ 163,767 Short-term investments 691,382 796,106 Restricted cash 2,519 2,327 Trade receivables, net 85,230 74,226 Receivables and prepaid expenses 39,500 35,063 Inventories 39,104 35,086 Total current assets 1,199,854 1,106,575 LONG-TERM ASSETS: Property and equipment, net 79,976 77,660 Field equipment, net 20,549 14,811 Right-of-use assets 48,402 27,120 Other long-term assets 12,413 14,618 Total long-term assets 161,340 134,209 TOTAL ASSETS $ 1,361,194 $ 1,240,784 Consolidated Balance Sheets USD in thousands (except share data) September 30, 2025 December 31, 2024 Unaudited Audited LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Convertible note $ 560,620 $ 558,160 Trade payables 118,922 105,086 Other payables, lease liabilities and accrued expenses 96,464 93,130 Total current liabilities 776,006 756,376 LONG-TERM LIABILITIES: Senior secured credit facility, net 194,639 97,300 Long-term leases 42,682 19,971 Employee benefit liabilities 6,515 6,940 Other long-term liabilities 19 18 Total long-term liabilities 243,855 124,229 TOTAL LIABILITIES 1,019,861 880,605 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS' EQUITY: Share capital - Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 111,979,981 shares and 108,516,819 shares at September 30, 2025 (unaudited) and December 31, 2024, respectively — — Additional paid-in capital 1,612,997 1,519,809 Accumulated other comprehensive income (loss) (5,806 ) (5,500 ) Retained earnings (accumulated deficit) (1,265,858 ) (1,154,130 ) TOTAL SHAREHOLDERS' EQUITY 341,333 360,179 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 1,361,194 $ 1,240,784 Non-U.S. GAAP Financial Measures Reconciliation USD in thousands Three months ended September 30, Nine months ended September 30, 2025 2024 % Change 2025 2024 % Change Net income (loss) $ (37,270 ) $ (30,570 ) 22 % $ (111,728 ) $ (102,705 ) 9 % Add: Income tax 7,248 8,985 (19 )% 16,432 26,749 (39 )% Add: Financial expenses (income), net (5,999 ) (10,507 ) (43 )% (18,111 ) (31,236 ) (42 )% Add: Depreciation and amortization 3,663 2,458 49 % 10,432 8,131 28 % EBITDA $ (32,358 ) $ (29,634 ) 9 % $ (102,975 ) $ (99,061 ) 4 % Add: Share-based compensation 29,321 31,364 (7 )% 85,016 97,278 (13 )% Adjusted EBITDA $ (3,037 ) $ 1,730 (276 )% $ (17,959 ) $ (1,783 ) 907 % Active Patients on Therapy September 30, 2025 2024 Optune Gio Optune Lua Total Optune Gio Optune Lua Total Active patients at period end (1) United States 2,176 104 2,280 2,186 14 2,200 International markets: Germany 595 31 626 558 520 12 570 France 499 — 499 393 — 393 Japan 474 — 474 437 — 437 Other international 533 4 537 506 7 513 International markets - Total 2,101 35 2,136 1,894 19 1,913 4,277 139 4,416 4,080 33 4,113 Important Safety Information What is Optune Gio ® approved to treat? Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older. Newly diagnosed GBM If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if: Your cancer is confirmed by your healthcare professional AND You have had surgery to remove as much of the tumor as possible Recurrent GBM If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if: You have tried surgery and radiation and they did not work or are no longer working AND You have tried chemotherapy and your GBM has been confirmed by your healthcare professional Who should not use Optune Gio? Optune Gio is not for everyone. Talk to your doctor if you have: An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment . Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy. What should I know before using Optune Gio? Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Gio. Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment What are the possible side effects of Optune Gio? Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions. Please visit OptuneGio.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions. Important Safety Information What is Optune Lua ® approved to treat? Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen. Who should not use Optune Lua? Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have: An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and difficulty breathing Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy. What should I know before using Optune Lua? Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Lua. Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it’s connected If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment. What are the possible side effects of Optune Lua? The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing). Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown/skin ulcer. Talk to your doctor if you have any of these side effects or questions. Please visit OptuneLua.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

IND application filed for MP0712, the Company’s lead Radio-DARPin candidate targeting DLL3 and co-developed with Orano Med, with Phase 1 initiation expected before year end 2025 First patient images from MP0712 compassionate care program to be presented at TRP in November; additional programs planned for 2026, including MP0726 targeting mesothelin. Updated data from Phase 1/2a trial of MP0533, a multispecific T cell engager for AML, to be presented at ASH in December Protocol approved for Phase 2 investigator-initiated trial of FAP x CD40 agonist MP0317 Strong financial position with cash runway until 2028 ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics (“Molecular Partners” or the “Company”), today announced corporate highlights and unaudited financial results for the third quarter of 2025. “We are excited to present initial clinical imaging data this November on MP0712, the 1st Radio-DARPin targeting DLL3, from compassionate care use in South Africa. The IND application for MP0712 has been filed and we see the alpha-targeting approaches for DLL3 in lung cancer as a valuable new modality for patients. Building on that progress, we are establishing a pipeline of additional Radio-DARPins with our partner Orano Med for selected targets, including mesothelin for ovarian cancer,” said Patrick Amstutz, Ph.D., CEO of Molecular Partners. “MP0533 is the first-ever tetraspecific T-cell engager to demonstrate safety and efficacy in AML. We will report additional data on optimized dosing and a deeper understanding on the ideal patient profile for MP0533. This understanding is important to plan next steps and is supportive of positioning of our drug in the treatment landscape.” Research & Development Highlights MP0712 (212Pb x DLL3), Radio-DARPin Pipeline and Collaboration with Orano Med The Phase 1 Investigational New Drug (IND) application for MP0712, a 212Pb-based Radio-DARPin therapy (RDT) candidate targeting the tumor-associated protein delta-like ligand 3 (DLL3), co-developed with Orano Med for the treatment of small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers, has been filed. Dialogue with the FDA is ongoing and, pending regulatory clearance, the Phase 1 trial is expected to initiate before the end of 2025. Molecular Partners presented preclinical data in April at the American Association for Cancer Research (AACR) Annual Meeting 2025, showing high tumor uptake, promising efficacy and a favorable safety profile for MP0712 in mouse models matching clinically-relevant DLL3 expression levels. In H1 2025, Molecular Partners accepted a request from the Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa to provide MP0712 for imaging use under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). This approach enables the generation of initial images applying MP0712 labeled with 203Pb in patients with SCLC and other DLL3-expressing neuroendocrine cancers. As per courtesy of NuMeRI, the Company will present first images from the MP0712 compassionate care program at the Targeted Radiopharmaceuticals (TRP) Summit EU in November. The NuMeRI team, lead by Dr. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Conference (TWC) in January 2026. 203Pb and 212Pb are an element-equivalent pair of lead (Pb) isotopes, with 203Pb primarily used for imaging and 212Pb for therapeutic applications (targeted alpha therapy, TAT). As a “matched pair”, pre-treatment imaging with 203Pb provides a prediction of treatment behavior with 212Pb. In January 2025, Molecular Partners and Orano Med expanded their agreement to co-develop up to ten radiotherapy programs. In addition to its world class expertise and capabilities in the development of TAT with 212Pb, Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization. Orano Med possesses virtually unlimited source material for 212Pb production and has established robust and independent supply and manufacturing capabilities required for the seamless delivery of TAT to clinical sites internationally. The second RDT program slated for clinical development is MP0726, targeting mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN, which has hampered the development of other MSLN-targeted therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. The Company is planning to progress several programs in 2026, including MP0726. MP0533 (Multispecific T Cell Engager; CD33 x CD123 x CD70 x CD3) MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)/AML (NCT05673057). Molecular Partners presented updated data from the study at the 30th Annual European Hematology Association (EHA) Congress in June, with promising antitumor activity observed in cohort 8. Three of 8 (>30%) evaluable patients in this cohort achieved a clinical response after the first cycle, and two patients maintained their responses for over three months, including one patient still on treatment today (>12 months response duration). Cohort 8 benefited from a higher starting dose and a faster step-up dosing schedule, leading to improved exposure within the predicted therapeutic range and notable blast reduction in most patients, with an acceptable safety profile after dose adjustment. Encouraged by these results, Molecular Partners amended the dosing scheme for cohorts 9 and 10 by further accelerating the step-up dosing, increasing the dosing frequency and introducing anti-CD20 premedication to achieve higher cumulative exposure as well as enhanced depth and duration of responses. Cohort 9 is exploring a lower target dose than cohort 8 to assess the safety of up to daily dosing in the first 14 days of treatment. Data from cohort 9 will be presented at the American Society of Hematology (ASH) Annual Meeting in December 2025. Cohort 10, which aims at reaching the same target dose as cohort 8 while exposing patients to more drug over time, is now enrolling and dosing patients. MP0533 continues to show broad activity in a mutation-agnostic manner, with initial blast reductions in a majority of patients treated, and an acceptable safety profile. The data continue to indicate that the patients more likely to see durable responses will be those who initiate therapy with a lower level of blasts at baseline. Molecular Partners plans to explore MP0533 in combination settings, both in patients with relapsed/refractory disease as well as in front-line setting, should favorable antitumor activity continue to be observed. Several consortia have approached Molecular Partners expressing interest in conducting such studies. The Company is engaging with key opinion leaders and regulators to discuss next steps. MP0317 (Tumor-Localized Agonist; FAP x CD40) Molecular Partners is supporting an investigator-initiated trial of MP0317, for which a study protocol has been approved (NCT07036380). This proof-of-concept randomized Phase 2 study, to be conducted by an expert network in France, is designed for the treatment of patients with advanced cholangiocarcinoma in combination with anti-PD-L1 therapy (durvalumab) and gemcitabine-cisplatin-based chemotherapy. The main objective of the study is to assess the 12-month progression free survival (PFS) in the experimental arm (N = 50 patients). MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies. Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 dose escalation trial of the localized CD40 agonist MP0317 in solid tumors at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in November 2024. Switch-DARPins (Next-Generation Immune Cell Engagers) By employing a multi-specific Switch-DARPin, Molecular Partners aims to increase the safety and potency of T cell engagers (TCEs). Preclinical proof-of-concept for a novel CD3 Switch-DARPin TCE with CD2 costimulation was presented at AACR in April 2025. The data show the feasibility of conditional T cell activation with potent co-stimulation in solid tumors, but not in healthy tissues. In addition, data showed that the CD3 Switch-DARPin activates T cells specifically in the presence of cells co-expressing the tumor targets MSLN and EpCAM, thereby increasing tumor specificity. The Company will present an update on the CD3 Switch-DARPin program at SITC in November 2025. Corporate Governance Highlights Molecular Partners appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer (CSO) and member of its Executive Committee, effective October 1, 2025. Martin brings a wealth of experience in oncology drug development, having previously contributed to the advancement of several innovative cancer therapies at major biotech and pharmaceutical companies. Financial and Business Outlook For the full year 2025, at constant exchange rates, the Company expects total operating expenses of CHF 55 – 60 million of which around CHF 6 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation. The Company's cash and cash equivalents and short-term time deposits were CHF 105 million as of September 30, 2025 and based on current operating assumptions, will be sufficient to fund its operating expenses and capital expenditure requirements until 2028. Financial Calendar About DARPin Therapeutics DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that open new dimensions of multi-functionality and multi-target specificity in drug design. The flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability of DARPins offer benefits to drug design over other currently available protein-based therapeutics. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector to a specific target; or multispecific, with the possibility of engaging more than five targets, and combining multiple and conditional functionalities in a unique DARPin drug candidate. The DARPin platform is designed to be a rapid and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapeutics have been clinically validated across several therapeutic areas and developed through to the registrational stage. About Molecular Partners AG Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN) is a clinical-stage biotech company pioneering the design and development of DARPin therapeutics for medical challenges other drug modalities cannot readily address. The Company has programs in various stages of pre-clinical and clinical development, with oncology as its main focus. Molecular Partners leverages the advantages of DARPins to provide unique solutions to patients through its proprietary programs as well as through partnerships with leading pharmaceutical companies. Molecular Partners was founded in 2004 and has offices in both Zurich, Switzerland and Concord, MA, USA. For more information, visit www.molecularpartners.com and find us on LinkedIn and Twitter / X @MolecularPrtnrs For further details, please contact: Seth Lewis, SVP Investor Relations & Strategy Concord, Massachusetts, U.S. seth.lewis@molecularpartners.com Tel: +1 781 420 2361 Laura Jeanbart, PhD, Head of Portfolio Management & Communications Zurich-Schlieren, Switzerland laura.jeanbart@molecularpartners.com Tel: +41 44 575 19 35 Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including without limitation: implied and express statements regarding the clinical development of Molecular Partners’ current or future product candidates; expectations regarding timing for reporting data from ongoing clinical trials or the initiation of future clinical trials; the potential therapeutic and clinical benefits of Molecular Partners’ product candidates and its RDT and Switch-DARPin platforms; the selection and development of future programs; Molecular Partners’ collaboration with Orano Med including the benefits and results that may be achieved through the collaboration; and Molecular Partners’ expected business and financial outlook, including anticipated expenses and cash utilization for 2025 and its expectation of its current cash runway. These statements may be identified by words such as “aim”, "anticipate”, “expect”, “guidance”, “intend”, “outlook”, “plan”, “potential”, “will” and similar expressions, and are based on Molecular Partners’ current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from Molecular Partners’ expectations include its plans to develop and potentially commercialize its product candidates; Molecular Partners’ reliance on third party partners and collaborators over which it may not always have full control; Molecular Partners’ ongoing and planned clinical trials and preclinical studies for its product candidates, including the timing of such trials and studies; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; the timing of and Molecular Partners’ ability to obtain and maintain regulatory approvals for its product candidates; the extent of clinical trials potentially required for Molecular Partners’ product candidates; the clinical utility and ability to achieve market acceptance of Molecular Partners’ product candidates; the potential that Molecular Partners’ product candidates may exhibit serious adverse, undesirable or unacceptable side effects; the impact of any health pandemic, macroeconomic factors and other global events on Molecular Partners’ preclinical studies, clinical trials or operations, or the operations of third parties on which it relies; Molecular Partners’ plans and development of any new indications for its product candidates; Molecular Partners’ commercialization, marketing and manufacturing capabilities and strategy; Molecular Partners’ intellectual property position; Molecular Partners’ ability to identify and in-license additional product candidates; unanticipated factors in addition to the foregoing that may cause Molecular Partners’ actual results to differ from its financial and business projections and guidance; and other risks and uncertainties set forth in Molecular Partners’ Annual Report on Form 20-F for the year ended December 31, 2024 and other filings Molecular Partners makes with the SEC from time to time. These documents are available on the Investors page of Molecular Partners’ website at www.molecularpartners.com. In addition, this press release contains information relating to interim data as of the relevant data cutoff date, results of which may differ from topline results that may be obtained in the future. Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.