Accessibility StatementSkip Navigation Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.) (PRNewsfoto/Halozyme Therapeutics, Inc.) SAN DIEGO and UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 17, 2025 /PRNewswire/ -- Merus N.V. (Nasdaq: MRUS) ("Merus"), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), and Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme"), a leader in subcuta ...

Financial Performance - Total revenue for the nine months ended September 30, 2025, was $47.466 million, a significant increase from $26.993 million in the same period of 2024, representing a growth of approximately 76.2%[17] - The company reported collaboration revenue of $33.843 million for the nine months ended September 30, 2025, compared to $26.993 million in the same period of 2024, marking an increase of about 25.5%[17] - Total revenue for Q3 2025 was $12.15 million, a decrease from $11.77 million in Q3 2024, representing a decline of approximately 5.5% year-over-year[48] - The company reported collaboration revenue of $11.87 million in Q3 2025, slightly down from $11.77 million in Q3 2024[48] - Total collaboration revenue for the three months ended September 30, 2025, was $12,150, an increase from $11,772 in the same period of 2024, representing a growth of approximately 3.2%[108] Expenses and Losses - Research and development expenses for the nine months ended September 30, 2025, were $254.059 million, up from $150.942 million in 2024, indicating a rise of about 68.3%[17] - The net loss for the nine months ended September 30, 2025, was $350.212 million, compared to a net loss of $184.403 million for the same period in 2024, reflecting an increase in losses of approximately 90.0%[17] - The operating loss for the nine months ended September 30, 2025, was $282.568 million, compared to $183.415 million in 2024, indicating an increase of approximately 54.0%[17] - Operating loss for Q3 2025 was $96.48 million, compared to a loss of $72.23 million in Q3 2024, reflecting a worsening of approximately 33.6% year-over-year[48] - Share-based compensation expense increased to $56.1 million for the nine months ended September 30, 2025, compared to $30.0 million for the same period in 2024[20] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $367.491 million, an increase from $293.294 million at December 31, 2024, showing a growth of about 25.3%[15] - Total assets increased to $904.196 million as of September 30, 2025, compared to $782.693 million at December 31, 2024, representing a growth of approximately 15.5%[15] - The company reported a cash and cash equivalents balance of $367.5 million as of September 30, 2025, down from $433.0 million at the end of the previous year[20] - The accumulated deficit reached $1,318.6 million as of September 30, 2025, reflecting ongoing significant expenses and operating losses[25] - The fair value of total debt securities as of September 30, 2025, was $459,350,000, compared to $443,607,000 as of December 31, 2024, showing an increase of 3.9%[51] Financing and Agreements - The company raised $326.0 million from the issuance of common stock during the nine months ended September 30, 2025[20] - On September 29, 2025, the company entered into a transaction agreement with Genmab A/S for a cash tender offer of $97.00 per common share[27] - The cash tender offer is set to expire on December 11, 2025, unless extended[28] - The company anticipates needing additional financing to support its operations until it can generate significant revenue from product sales[26] - The Company entered into a collaboration agreement with Gilead Sciences, Inc., receiving a non-refundable upfront payment of $56.0 million and selling 452,527 common shares for $25.0 million[71] Legal and Regulatory Matters - The company is currently involved in litigation against Xencor, alleging patent infringement, with proceedings ongoing following a court ruling[63][64] - The company has agreed to pay Genmab a termination fee of $240 million under specified circumstances if the Transaction Agreement is terminated[36] - Genmab will be required to pay a regulatory termination fee of $416 million to the company if the Transaction Agreement is terminated due to the Acceptance Time not occurring by the outside date[37] Market and Economic Conditions - A hypothetical 20% weakening of the U.S. dollar against the euro would have decreased the Company's net loss for the quarter ended September 30, 2025, by approximately $19.4 million[172] - The Company does not expect its operating results or cash flows to be materially affected by sudden changes in market interest rates due to the short-term nature of its investment portfolio[171] - The Company anticipates that a significant portion of its expenses will continue to be denominated in euros, exposing it to foreign currency exchange risk[172] - Inflation has not materially affected the Company's historical results, but significant inflationary pressures could adversely impact its financial condition and operations[173] Other Financial Metrics - The effective income tax rate for the nine months ended September 30, 2025, was 2.8%, significantly lower than the enacted rate of 25.8% in the Netherlands due to a valuation allowance against net deferred tax assets[60] - The company established a full valuation allowance against deferred tax assets in the Netherlands, indicating a cautious approach to recognizing these assets[56] - The total lease cost included in operating expenses for the three months ended September 30, 2025, was $761,000, compared to $587,000 for the same period in 2024, reflecting a 29.5% increase[70]

October 2025 Corporate Presentation Disclaimer This presentation (including any oral commentary that accompanies this presentation) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the planned completion of the transactions contemplated by the transaction ...

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Core Insights - Merus N.V. announced interim clinical data for petosemtamab, a bispecific antibody, showing promising response rates in metastatic colorectal cancer (mCRC) patients [1][2][3] Group 1: Clinical Data Summary - In the ongoing phase 2 trial, petosemtamab demonstrated a 100% response rate in first-line (1L) left-sided mCRC patients (n=8) and a 62% response rate in second-line (2L) mCRC patients (n=13) [1][3] - The trial included 54 patients with left- and/or right-sided, KRAS, NRAS, and BRAF wildtype microsatellite stable mCRC, treated with petosemtamab in combination with FOLFOX/FOLFIRI or as monotherapy [3] - In the 1L treatment group, 10 patients were efficacy evaluable, with 8 left-sided patients showing an 80% response rate, including 1 confirmed complete response and 7 partial responses [3][7] Group 2: Mechanism of Action and Potential Impact - Petosemtamab targets both EGFR and LGR5, which may provide a new treatment option for patients with EGFR inhibitor-naïve mCRC [2] - The early results suggest that petosemtamab could become a transformational treatment and a new standard of care for various solid tumors [2] Group 3: Safety Profile - The safety profile of petosemtamab in mCRC appears consistent with its established profile in recurrent/metastatic head and neck squamous cell carcinoma, with no significant overlapping toxicities identified [7] - Infusion-related reactions were managed effectively, with no discontinuations due to these reactions [7]

Core Points - Genmab A/S is initiating a cash tender offer to acquire all outstanding common shares of Merus N.V. for $97.00 per share [1] - The offer is part of a transaction agreement dated September 29, 2025, between Genmab, its subsidiary, and Merus [1] - Merus's Board of Directors has recommended that shareholders accept the offer [2] Offer Details - The tender offer will expire at 5:00 p.m. New York City time on December 11, 2025, unless extended [3] - If conditions are met, a subsequent offering period will commence on the first business day following the expiration [3] - The offer is not subject to a financing condition but is subject to other conditions, including a minimum tender condition [4] Shareholder Information - Merus shareholders are advised to review the tender offer documents filed with the SEC before deciding to tender their shares [5] - These documents can be accessed for free on the SEC's website or through the information agent for the tender offer [5] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics [6] - The company has a vision to transform the lives of patients with cancer and serious diseases through advanced antibody medicines by 2030 [6] - Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with a global presence [7]

Core Insights - The article highlights stocks reaching new 52-week highs, indicating market recognition of strong fundamentals and potential catalysts for growth [1][2]. Company Summaries Cogent Biosciences Inc. (COGT) - Cogent Biosciences plans to file its first New Drug Application for Bezuclastinib by the end of 2025, targeting non-advanced systemic mastocytosis [3]. - A phase III trial comparing Bezuclastinib with Sutent is ongoing, with results expected in the second half of 2025 [4]. - The stock reached a 52-week high of $16.99, up from $7.25 when last featured [5]. Assembly Biosciences Inc. (ASMB) - Assembly Biosciences is advancing four key development programs, with ABI-5366 expected to enter phase 2 studies in mid-2026 [6]. - Interim data for ABI-1179 is anticipated this fall, while ABI-6250 is in a phase 1a trial [7]. - The stock hit a 52-week high of $28, up from $14.53 when last featured [8]. Compass Therapeutics Inc. (CMPX) - Compass Therapeutics is conducting a phase 2/3 study of Tovecimig for advanced biliary tract cancer, with analyses of secondary endpoints expected in Q1 2026 [9][10]. - The stock reached a 52-week high of $4.39, up from $2.91 when last featured [11]. NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam Pharma is developing Obicetrapib as a cholesterol-lowering therapy, with positive data from the BROADWAY trial [12][13]. - The company has completed two additional phase III trials and submitted marketing applications to the EMA [16]. - The stock reached a 52-week high of $39.76, up from $21.56 when last featured [17]. Mineralys Therapeutics Inc. (MLYS) - Mineralys is developing Lorundrostat for uncontrolled hypertension, with a pivotal phase III trial achieving its primary endpoint [19]. - A phase II trial for overweight participants with OSA is ongoing, with topline results expected in 1H 2026 [20]. - The stock hit a 52-week high of $43.88, up from $10.34 when last featured [20]. Kymera Therapeutics Inc. (KYMR) - Kymera is set to report data from its phase I trial of KT-621 this quarter, with phase 2b studies planned for late 2025 and early 2026 [21][22]. - The stock reached a 52-week high of $60, up from $40 when last featured [22]. Insmed Inc. (INSM) - Insmed has two approved drugs and is conducting a phase 3 trial of Arikayce, with topline results expected in 1H 2026 [24][25]. - The stock hit a high of $166.54, up from $76.54 when last featured [26]. Adaptive Biotechnologies Corp. (ADPT) - Adaptive Biotechnologies expects MRD revenue between $190 million and $200 million for 2025, up from $145.5 million in 2024 [28][29]. - The stock reached a 52-week high of $15.94, up from $9.80 when last featured [29]. BridgeBio Pharma Inc. (BBIO) - BridgeBio has upcoming topline results from the FORTIFY and CALIBRATE studies expected in Fall 2025 [30]. - The stock reached a 3-year high of $56.24, up from $25.10 when last featured [31]. Tarsus Pharmaceuticals Inc. (TARS) - Tarsus reported strong sales for Xdemvy, with Q2 2025 sales of $102.7 million, compared to $40.8 million in Q2 2024 [32]. - The stock hit an all-time high of $70.15, up from $25.01 when last featured [34]. Palvella Therapeutics Inc. (PVLA) - Palvella's QTORIN is under development for various skin diseases, with a phase 2 trial expected to report data in mid-December 2025 [35][36]. - The stock reached a 52-week high of $76.76, up from $25 when last featured [36]. Merus N.V. (MRUS) - Merus agreed to be acquired by Genmab for $97 per share, with the deal expected to close in early Q1 2026 [37]. - The stock was at $39.71 when last featured [39]. Nephros Inc. (NEPH) - Nephros reported net revenue of $4.4 million for Q2 2025, marking its third consecutive quarter of profitability [40][41]. - The stock hit a 52-week high of $5.98, up from $2.93 when last featured [42].

Core Insights - The article discusses the promising interim clinical data for petosemtamab, a bispecific antibody, in combination with standard chemotherapy regimens FOLFOX/FOLFIRI for metastatic colorectal cancer (mCRC) and as a monotherapy for later lines of treatment [1][2] Clinical Trial Data - As of April 28, 2025, 36 patients with microsatellite stable mCRC received petosemtamab 1500 mg Q2W, either in combination with FOLFOX/FOLFIRI or as monotherapy [2] - In the 1L treatment group, 7 patients were treated, with 3 being efficacy evaluable, showing 1 unconfirmed complete response and 2 partial responses [2] - In the 2L treatment group, 10 patients were treated, with 8 being efficacy evaluable, resulting in 4 partial responses and 3 stable diseases [2] - In the 3L+ monotherapy group, 19 patients were treated, with 14 being efficacy evaluable, showing 1 unconfirmed partial response and 6 stable diseases [2] Safety Profile - No fatal treatment-related adverse events (TEAEs) were observed across all cohorts [2] - Common TEAEs for petosemtamab plus FOLFOX included dermatitis acneiform (71%), constipation (43%), fatigue (43%), and peripheral neuropathy (43%) [2] - Common TEAEs for petosemtamab plus FOLFIRI included diarrhea (70%), mucosal inflammation (50%), and fatigue (40%) [2] - For petosemtamab monotherapy, frequent TEAEs included rash (58%) and nausea (26%) [7] Upcoming Presentations - The updated clinical data will be presented in a plenary session on October 24, 2025, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [3]

Core Insights - Merus N.V. announced the acceptance of two abstracts on petosemtamab for presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston from October 22-26, 2025 [1][2] Company Overview - Merus is an oncology company focused on developing innovative full-length human bispecific and trispecific antibody therapeutics, known as Multiclonics, which exhibit features similar to conventional human monoclonal antibodies [5] Product Information - Petosemtamab, also known as MCLA-158, is a Biclonics low-fucose human full-length IgG1 antibody targeting EGFR and LGR5, designed to inhibit EGFR-dependent signaling and enhance antibody-dependent cell-mediated cytotoxicity [4] Presentation Details - Initial interim data from a phase 2 trial evaluating petosemtamab in combination with standard chemotherapy for metastatic colorectal cancer will be presented in a plenary session on October 24, 2025 [2][3] - A poster presentation on the preclinical evaluation of petosemtamab on cancer stem cells will also take place on the same day [2][3]

Core Insights - Genmab A/S (GMAB) shares have increased by 21.9% over the past month following the announcement of its acquisition of Merus N.V. (MRUS) for $97 per share, totaling approximately $8 billion [1][6] - The acquisition price represents a 41% premium over Merus' closing price of $68.89 on September 26, 2025, with the deal expected to close in early Q1 2026, pending customary conditions [2][3] Company Strategy - The acquisition of Merus signifies Genmab's strategic transition from a licensing-based model to a fully owned business framework, aimed at diversifying its revenue streams [3] - The addition of petosemtamab, Merus' lead late-stage oncology candidate, enhances Genmab's proprietary pipeline and aligns with its expertise in antibody therapy development [4][6] Growth Potential - Genmab anticipates multiple new drug launches by 2027 across various oncology indications, bolstering its long-term growth prospects [4] - Petosemtamab is projected to contribute at least $1 billion in annual sales by 2029, with potential for multi-billion-dollar revenue growth in subsequent years [10] Clinical Development - Petosemtamab is currently being evaluated in two phase III studies for head and neck cancer, with interim results expected in 2026 [9] - The candidate has received two Breakthrough Therapy designations from the FDA, indicating its potential as a first-in-class therapy for head and neck cancer [8]