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Merus Announces Publication of an Abstract on Petosemtamab with Pembrolizumab as 1L treatment of r/m HNSCC at the 2024 ASCO® Annual Meeting
globenewswire.com· 2024-05-23 21:00
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors Rapid oral presentation title: Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 study. Observations in the abstract include: Presentation Details: Abstract #: 6014 Session Title: Head and Neck Cancer Session Date and Time: June 3, 2024, 8:00-9:30 a.m. CT As full presentations become available at the 2024 ASCO® Annual Meeting, they will cont ...
Merus Announces Publication of Abstracts for Presentation at the 2024 ASCO® Annual Meeting
globenewswire.com· 2024-05-23 21:00
MCLA-145 monotherapy and in combination with pembrolizumab rapid oral session presentation: June 2, 2024, 11:30 a.m.-1:00 p.m. CT MCLA-129 in NSCLC with c-MET exon 14 skipping mutations poster presentation: June 3, 2024, 1:30- 4:30 p.m. CT UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today an ...
Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA
Newsfilter· 2024-05-13 12:00
Petosemtamab granted BTD for the treatment of previously treated HNSCC UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for petosemtamab for the treatment of patients with recurrent or metastatic head and ...
Merus(MRUS) - 2024 Q1 - Quarterly Report
2024-05-08 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 OR FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 For the transition period from to ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37773 MERUS N.V. (Exact name of registrant as specified in its charter) The Netherlands Not Applicable (State or other jurisdiction of inc ...
Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC
Newsfilter· 2024-05-06 20:05
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung ...
Merus (MRUS) Moves 7.1% Higher: Will This Strength Last?
Zacks Investment Research· 2024-04-26 13:01
Merus N.V. (MRUS) shares soared 7.1% in the last trading session to close at $44.93. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 6.2% loss over the past four weeks.Last month, the company entered into a collaboration and license agreement with Gilead Sciences to discover novel dual tumor-associated antigens (TAA) targeting trispecific antibodies and develop multiple separate preclinical research programs. This might have driv ...
Merus(MRUS) - 2023 Q4 - Annual Report
2024-02-28 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) c ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37773 MERUS N.V. (Exact name of Registrant as specified in its Charter) The Netherlands Not Applicable (State or other jurisdiction ...
Merus(MRUS) - 2023 Q3 - Quarterly Report
2023-11-02 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37773 MERUS N.V. (Exact name of registrant as specified in its charter) The Netherlands Not Applicable (State or other jurisdiction of ...
Merus(MRUS) - 2023 Q2 - Quarterly Report
2023-08-07 20:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37773 MERUS N.V. (Exact name of registrant as specified in its charter) The Netherlands Not Applicable (State or other jurisdiction of inco ...
Merus(MRUS) - 2023 Q1 - Quarterly Report
2023-05-04 20:06
Financial Performance - Total revenue for Q1 2023 was $13.5 million, a 15.8% increase from $11.7 million in Q1 2022[16]. - Operating expenses increased to $50.3 million in Q1 2023, up 29.8% from $38.7 million in Q1 2022[16]. - Net loss for Q1 2023 was $39.7 million, compared to a net loss of $18.9 million in Q1 2022, representing a 109.5% increase in losses[16]. - Basic and diluted net loss per share for Q1 2023 was $0.86, compared to $0.43 in Q1 2022[16]. - The company reported a net cash used in operating activities of $36.7 million for Q1 2023, compared to $46.4 million in Q1 2022[19]. - The company expects to continue incurring significant expenses and operating losses for the foreseeable future[12]. - As of March 31, 2023, the company reported an accumulated deficit of $637.9 million[25]. - The company anticipates needing additional financing to support ongoing operations and may pursue public equity offerings or collaborations[26]. Cash and Assets - Cash and cash equivalents decreased to $102.6 million as of March 31, 2023, down from $147.7 million at the end of 2022[15]. - Total assets decreased to $338.5 million as of March 31, 2023, from $376.5 million at the end of 2022[15]. - The company holds $39.4 million in cash equivalents as of March 31, 2023, up from $18.4 million as of December 31, 2022[35]. - The total investments in debt securities increased from $197.3 million as of December 31, 2022, to $224.1 million as of March 31, 2023[35]. - The fair value of debt securities was $223.5 million as of March 31, 2023, compared to $196.3 million as of December 31, 2022[35]. - As of March 31, 2023, the company held marketable securities valued at $184.7 million, a decrease from $189.7 million as of March 31, 2022[128]. - The company has no outstanding debt subject to interest rate risk as of March 31, 2023[128]. Collaboration and Revenue - Collaboration revenue for Q1 2023 was $13.5 million, compared to $11.7 million in Q1 2022, indicating growth in collaborative efforts[16]. - Total collaboration revenue for the three months ended March 31, 2023, was $13.499 million, a 15.8% increase from $11.655 million in the same period of 2022[68]. - Upfront payments contributed $8.392 million to total collaboration revenue in Q1 2023, compared to $8.662 million in Q1 2022, reflecting a decrease of 3.1%[68]. - Eli Lilly agreed to pay the Company a $40.0 million non-refundable upfront payment and purchased 706,834 common shares for $20.0 million, totaling $60.0 million in initial collaboration funds[45]. - The transaction price at inception was $43.5 million, derived from the upfront payment and share purchase proceeds, with variable consideration associated with research funding[49]. - As of March 31, 2023, the Company recognized a $2.5 million milestone from Incyte related to the initiation of a Phase 1 study, with no additional milestones achieved during the same period[57]. - The Company has achieved three milestones under the Simcere Agreement, receiving an aggregate of $1.8 million in milestone payments before the agreement was terminated[64]. - Research activities under the Lilly collaboration are ongoing, with no milestones achieved to date as of March 31, 2023[54]. - The Company identified three performance obligations in the Simcere Agreement, with a total fixed consideration of $2.75 million allocated to these obligations[63]. - Lilly has the right to extend the research term to 2025 for an additional fee of $0.5 million, increasing the transaction price for one of the programs[53]. - The Company retains all rights not granted to Lilly, with potential future milestones and royalties dependent on product development and commercialization[46]. - The balance of deferred revenue as of March 31, 2023, was $61.0 million, down from $68.2 million at the beginning of the year, reflecting revenue recognized during the period[66]. - As of March 31, 2023, the balance of unbilled receivables was $2.6 million, primarily representing reimbursement revenue to be billed in the next period[67]. Expenses and Costs - Operating expenses increased to $50.3 million in Q1 2023, up 29.8% from $38.7 million in Q1 2022[16]. - Accrued research and development expenses rose to $31.98 million as of March 31, 2023, from $26.16 million as of December 31, 2022[38]. - Total lease costs included in operating expenses increased to $740,000 for the three months ended March 31, 2023, compared to $461,000 for the same period in 2022[44]. - Research and development expenses for Q1 2023 were $24,000, significantly lower than $360,000 in Q1 2022, indicating a reduction of 93.3%[68]. - Stock-based compensation expense totaled $5.750 million for Q1 2023, up from $5.334 million in Q1 2022, representing an increase of 7.8%[72]. Currency and Market Impact - A hypothetical 15% weakening of the U.S. dollar against the euro would have increased the net loss for Q1 2023 by approximately $6.3 million[129]. - The weighted-average grant date fair value of options granted in Q1 2023 was $10.29 per option[73]. - The company issued and sold 2,720,846 shares of common stock under the Sales Agreement, generating gross proceeds of $59.5 million as of December 31, 2022[71]. - No sales were made under the Sales Agreement during the three months ended March 31, 2023[71].