MRUS Merus N.V.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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MCLA-158
Colorectal cancer
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Phase 1
Phase 1
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Zenocutuzumab (MCLA-128)
Solid tumors - NRG1
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Phase 1/2
Phase 1/2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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MCLA-129
Solid Tumors
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Phase 1
Phase 1
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First patient to be dosed 1Q 2021.
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MCLA-117
Acute Myeloid Leukemia
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Phase 1
Phase 1
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Phase 1 interim data presented at EHA June 2020.
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MCLA-145
Solid tumors
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Phase 1
Phase 1
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Phase 1 dosing has commenced - May 9, 2019.
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Latest News
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced that Bill Lundberg, M.D., President and Chief Executive Officer, will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 14:40 p.m. GMT/9:40 a.m. ET.
A live webcast of the presentation will be available on the Investors page of the Company's website, http://www.merus.nl/. An archived presentation will be available on the Merus website for a limited time.
About Merus
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus' website, www.merus.nl and https://twitter.com/MerusNV.Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected]
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 09, 2020 (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 preclinical data from its MCLA-145 program will be presented at the Society for Immunotherapy of Cancer (SITC) annual meeting being held virtually on November 1015, 2020.
"We look forward to sharing data on MCLA-145, our clinical stage Biclonics® bispecific antibody directed at CD137 on T cells and PD-L1 on cancer cells," said Andrew Joe, M.D., Chief Medical Officer of Merus. "MCLA-145 is the most advanced program in our collaboration with Incyte. In preclinical studies, MCLA-145 demonstrates potent anti-tumor effect and does not appear to exhibit the safety liabilities that have been observed with other potent CD137 agonists."
E-Poster Presentations:
Title: MCLA-145 (CD137xPD-L1): a potent CD137 agonist and immune checkpoint inhibitor that does not show signs of peripheral toxicity in preclinical models
Poster #: 814- Authors: Kees Bol, Wilfred Marissen, Jeroen Elassiass-Schaap, Paul Tacken, Steef Engels, Liang-Chuan Wang, Arpita Mondal, Mark Throsby, Alan Roberts, Patrick Mayes, Cecile Geuijen
Title: MCLA-145 is a bispecific IgG1 antibody that inhibits PD-1/PD-L1 signaling while simultaneously activating CD137 signaling on T cells
Poster #: 820- Authors: Paul Tacken, Liang-Chuan Wang, Rinse Klooster, Pieter Fokko van Loo, Jing Zhou, Arpita Mondal, Yao-bin Liu, Arjen Kramer, Thomas Condamine, Alla Volgina, Linda J. A. Hendriks, Hans van der Maaden, Eric Rovers, Steef Engels, Floris Fransen, Renate den Blanken-Smit, Vanessa Zondag-van der Zande, Abdul Basmeleh, Willem Bartelink, Ashwini Kulkarni, Wilfred Marissen, Cheng-Yen Huang, Leslie Hall, Shane Harvey, Chrysi Kanellopoulou, Shaun Stewart, Horacio Nastri, Alexander B. H. Bakker, Ton Logtenberg, Simon Plyte, Patrick A. Mayes, Mark Throsby, Cecile Geuijen
Posters will be on display from Monday, November 9, 2020 until the virtual poster hall closes on December 31, 2020.
Abstracts are available on the SITC 2020 website at https://www.sitcancer.org/2020.
MCLA-145 is currently being evaluated in a Phase 1 open-label, multicenter dose escalation study, including a safety dose expansion phase, in patients with solid tumors. MCLA-145 is the first drug candidate co-developed under Merus' global collaboration and license agreement with Incyte Corporation, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from our Biclonics® platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States, and Incyte is responsible for its development and commercialization outside the United States.About Merus N.V.
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus' website, www.merus.nl and https://twitter.com/MerusNV.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding MCLA-145 potential safety, efficacy, mechanism of action and potential of Biclonics® in preclinical or clinical development to treat cancer. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics® and bispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, including for the treatment of rare subpopulations such as NRG1 fusions, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaboration with Incyte or any of our other collaborators, or Incyte or any of our other collaborators may fail to perform adequately under our collaborations with them; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission, or SEC, on November 5, 2020, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected]
- Authors: Kees Bol, Wilfred Marissen, Jeroen Elassiass-Schaap, Paul Tacken, Steef Engels, Liang-Chuan Wang, Arpita Mondal, Mark Throsby, Alan Roberts, Patrick Mayes, Cecile Geuijen
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–Clinical data and program update planned for lead program Zenocutuzumab ("Zeno") in 2Q 2021–
– MCLA-129 expected to enter clinic in 2021 –UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 05, 2020 (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 TriclonicsTM), today announced financial results for the third quarter that ended September 30, 2020, and provided a business update.
"Our lead program with Zeno in neuregulin 1 (NRG1) fusion cancers continues to advance steadily, and we look forward to sharing data from the eNRGy clinical trial and the Early Access Program in the second quarter of 2021," said Bill Lundberg, M.D., President, Chief Executive Officer and Principal Financial Officer of Merus. "We continue to add eNRGy clinical trial sites globally and expand our comprehensive screening efforts, focused on pancreatic cancer, to aid in identifying patients who may be eligible for our trial. Our additional clinical pipeline programs are progressing, and our preclinical candidate, MCLA-129 targeting EGFR and c-MET, is expected to enter the clinic in 2021."
Clinical Programs
Zenocutuzumab, or "Zeno" (MCLA-128: HER3 x HER2 Biclonics®)
NRG1 gene fusion (NRG1+) Cancers: Phase 1/2 eNRGy trial clinical data and program update planned for 2Q 2021Merus continues to enroll patients in the Phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. Merus believes that Zeno continues to demonstrate encouraging single agent activity in NRG1+ cancers and appears to be well tolerated, consistent with previously reported safety data in the overall patient population treated with Zeno monotherapy. The initial clinical responses reported in late 2019 support the potential for Zeno to be particularly effective in patients with NRG1+ cancers, a patient population with significant unmet need.
Earlier this year, Zeno was granted Orphan Drug Designation by the U.S. FDA for pancreatic cancer. Pancreatic cancer is estimated to occur in approximately 57,000 patients annually in the U.S., according to the National Cancer Institute (NCI) SEER database. Pancreatic ductal adenocarcinoma (PDAC), the most common subtype of pancreatic cancer, is one of the most aggressive solid tumor cancers and the fourth leading cause of cancer-related deaths.
Merus plans to present efficacy data from the eNRGy trial and Early Access Program (EAP) at a major medical conference in the second quarter of 2021 including results from more than 30 patients with NRG1+ pancreatic, non-small cell lung and other cancers with the opportunity for four or more months of follow up. At that time, Merus plans to also discuss details of the program and overall strategy.
Clinical trial site activation, patient identification and enrollment, and clinical operations activities for the eNRGy trial have increased since the second quarter of 2020. The Company has previously noted that enrollment and clinical operations activities in this trial have continued, albeit at a slower pace, throughout the COVID-19 pandemic. Over 30 clinical trial sites are now open globally, with additional sites planned for the coming months. Merus expects patient identification and enrollment to continue to accelerate through the Company's ongoing patient screening and patient identification initiatives, including several programs with clinical support and testing collaborators.
Merus' comprehensive patient recruitment strategy includes agreements with Caris Life Sciences (Caris), Foundation Medicine Inc., and Tempus Labs Inc., to identify NRG1+ patients and determine suitability of enrollment of these patients in the eNRGy trial and EAP. Separately, Merus has a collaboration with Caris, through which Caris has agreed to provide tumor DNA and RNA molecular testing, focused on pancreatic cancer, which occurs in a patient population that may otherwise not undergo molecular diagnostic testing due to the current lack of personalized, molecularly-driven treatment options for this cancer type.
In October 2020, Merus entered into an agreement with myTomorrows, in which it has agreed to raise awareness of NRG1+ molecular screening offered by Merus for eligible patients, focusing on pancreatic cancer, to identify the presence of NRG1+ and to increase awareness of and potential enrollment in Merus' eNRGy clinical trial.
Details of the eNRGy trial, including current trial sites, can be found at www.ClinicalTrials.gov and Merus' trial website at www.nrg1.com, or by calling 1-833-NRG-1234.
MCLA-158 (Lgr5 x EGFR Biclonics®): Solid Tumors
Phase 1 trial continues; Update expected by year endMCLA-158 is currently being evaluated in a Phase 1 open-label, multicenter dose escalation study, including a safety dose expansion phase in patients with solid tumors. MCLA-158 has demonstrated a favorable safety profile with no observed dose limiting toxicities to date. Merus plans to provide a clinical update on the Phase 1 trial by year end.
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
Phase 1 trial advancing as plannedMCLA-145 is currently being evaluated in a Phase 1 open-label, multicenter dose escalation study, including a safety dose expansion phase, in patients with solid tumors. MCLA-145 is the first drug candidate co-developed under Merus' global collaboration and license agreement with Incyte Corporation, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from our Biclonics® platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States, and Incyte is responsible for its development and commercialization outside the United States.
MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
IND-enabling studies ongoing, first patient planned to be dosed in 2021Merus is currently conducting IND-enabling studies of MCLA-129 for the treatment of various solid tumors in collaboration with Betta Pharmaceuticals and the first patient is planned to be dosed in 2021. Merus presented preclinical data in late 2019 demonstrating that MCLA‑129 inhibited the growth of tyrosine kinase resistant non-small cell lung cancer (NSCLC) cell lines and NSCLC tumors in xenograft models. Betta holds exclusive rights to develop MCLA-129 in China, while Merus retains full ex‑China rights.
Third Quarter 2020 Financial Results
The Company ended the third quarter with cash, cash equivalents and marketable securities of $190.2 million compared to $241.8 million at December 31, 2019. The decrease was primarily the result of cash used in operations, and effects of exchange rate changes.
Comparison of the Three Months Ended September 30, 2020 and 2019
Collaboration revenue for the three months ended September 30, 2020 increased by $0.3 million as compared to the three months ended September 30, 2019, primarily as a result of an increase in Incyte reimbursement revenue of $2.0 million due to increased activities, and $0.5 million in other net increases, including the achievement of a Simcere milestone, partially offset by a decrease of $2.2 million in Ono milestone revenue due to the achievement of milestones in the prior year period that did not recur in the current year period. The change in exchange rates did not significantly impact collaboration revenue.
Research and development expense for the three months ended September 30, 2020 increased by $4.0 million as compared to the three months ended September 30, 2019, primarily as a result of an increase in headcount, higher manufacturing related costs, and higher pre-clinical research and development-related costs related to the Company's programs, particularly increases in costs for zenocutuzumab.
General and administrative expense for the three months ended September 30, 2020 increased by $1.1 million as compared to the three months ended September 30, 2019, primarily as a result increases in stock-based compensation, insurance, intellectual property related costs and other items, partially offset by a decrease in consulting costs.
Other loss, net for the three months ended September 30, 2020 was $4.8 million as compared to other income, net of $4.1 million for the three months ended September 30, 2019. Other income (loss), net consists of interest earned on the Company's cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange gains on the Company's foreign denominated cash, cash equivalents and marketable securities.
Comparison of the Nine Months Ended September 30, 2020 and 2019
Collaboration revenue for the nine months ended September 30, 2020 decreased by $2.7 million as compared to nine months ended September 30, 2019 primarily as a result of an increase in Incyte reimbursement revenue of $0.6 million due to increased activities, a decrease of $3.4 million in Ono milestone revenue due to the achievement of milestones in the prior year which period that did not recur in the current year period, partially offset by an increase in Incyte reimbursement revenue of $0.6 million due to increased activities.
Research and development expense for the nine months ended September 30, 2020 increased by $12.1 million as compared to the nine months ended September 30, 2019, primarily as a result of an increase in manufacturing related costs, and higher pre-clinical research and development-related costs related to the Company's programs, particularly increases in costs for zenocutuzumab, offset by decreases in costs for MCLA-145. On a comparative basis, stock-based compensation included in research and development costs for the nine months ended September 30, 2020 decreased by $0.7 million compared to the nine months ended September 30, 2019, primarily due to the modification and forfeiture of awards held by departing executives.
General and administrative expense for the nine months ended September 30, 2020 increased by $3.1 million as compared to the nine months ended September 30, 2019, primarily as a result increases in stock-based compensation, insurance, facilities, intellectual property related costs and other items, partially offset by a decrease in consulting costs.
Other loss, net for the nine months ended September 30, 2020 was $3.9 million as compared to other income, net of $6.2 million for the nine months ended September 30, 2019. Other income (loss), net consists of interest earned on the Company's cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange gains on the Company's foreign denominated cash, cash equivalents and marketable securities.
Financial Outlook
Based on the Company's current operating plan, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2022.
MERUS N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(Amounts in thousands, except per share data)September 30,
2020December 31,
2019ASSETS Current assets: Cash and cash equivalents $ 139,179 $ 197,612 Marketable securities 51,021 42,153 Accounts receivable 538 941 Accounts receivable (related party) 1,568 1,711 Prepaid expenses and other current assets 9,010 4,951 Total current assets 201,316 247,368 Marketable securities — 2,009 Property and equipment, net 3,792 3,715 Operating lease right-of-use assets 4,229 5,215 Intangible assets, net 2,784 2,876 Deferred tax assets 291 288 Other assets 1,081 1,905 Total assets $ 213,493 $ 263,376 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 4,720 $ 3,029 Accrued expenses 19,819 13,536 Current portion of lease obligation 1,536 1,380 Current portion of deferred revenue 699 941 Current portion of deferred revenue (related party) 18,657 17,901 Total current liabilities 45,431 36,787 Lease obligation 2,736 3,872 Deferred revenue, net of current portion 331 780 Deferred revenue, net of current portion (related party) 80,494 90,637 Total liabilities 128,992 132,076 Stockholders' equity: Common shares, €0.09 par value; 45,000,000 shares authorized;
29,074,536 and 28,882,217 shares issued and outstanding as at
September 30, 2020 and December 31, 2019, respectively$ 2,938 $ 2,918 Additional paid-in capital 448,617 441,395 Accumulated other comprehensive income 5,094 1,586 Accumulated deficit (372,148 ) (314,599 ) Total stockholders' equity 84,501 131,300 Total liabilities and stockholders' equity $ 213,493 $ 263,376 MERUS N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(Amounts in thousands, except per share data)Three Months Ended
September 30,Nine Months Ended
September 30,2020 2019 2020 2019 Collaboration revenue $ 695 $ 2,558 $ 1,207 $ 4,496 Collaboration revenue (related party) 7,875 5,690 19,720 19,061 Grant revenue — (93 ) — (216 ) Total revenue 8,570 8,155 20,927 23,341 Operating expenses: Research and development 17,538 13,511 48,234 36,078 General and administrative 9,136 8,024 26,061 22,979 Total operating expenses 26,674 21,535 74,295 59,057 Operating loss (18,104 ) (13,380 ) (53,368 ) (35,716 ) Other income (loss), net: Interest (expense) income, net (12 ) 591 367 1,756 Foreign exchange (losses) gains (4,782 ) 3,468 (4,243 ) 4,474 Other income (loss), net (4,794 ) 4,059 (3,876 ) 6,230 Net loss before income taxes (22,898 ) (9,321 ) (57,244 ) (29,486 ) Tax expense (benefit) 177 (54 ) 305 239 Net loss $ (23,075 ) $ (9,267 ) $ (57,549 ) $ (29,725 ) Other comprehensive income (loss): Currency translation adjustment 4,414 (3,561 ) 3,508 (4,363 ) Comprehensive loss $ (18,661 ) $ (12,828 ) $ (54,041 ) $ (34,088 ) Net loss per share attributable to common stockholders:
Basic and diluted$ (0.64 ) $ (0.55 ) $ (1.86 ) $ (1.46 ) Weighted-average common shares outstanding:
Basic and diluted29,061 23,403 29,014 23,388 About Merus N.V.
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus' website, www.merus.nl and https://twitter.com/MerusNV.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding the sufficiency of our cash, cash equivalents and marketable securities, the promise of and potential benefit of our clinical assets, our lead program Zeno in NRG1 fusion cancers continuing to advance steadily; the continuing addition of eNRGy clinical trial sites globally and expanding our comprehensive screening efforts, focused on pancreatic cancer to aid in identifying patients who may be eligible for our trial; our plans to present efficacy data from the eNRGy trial and EAP at a major medical conference in the second quarter of 2021 including results from more than 30 patients with NRG1+ pancreatic, non-small cell lung and other cancers with the opportunity for four or more months of follow up and plans to also discuss details of the program and overall strategy; the potential for Zeno to be particularly effective in patients with NRG1+ cancers, our expectations surrounding patient enrollment in our clinical trials, including enrolling patients for the Phase 1/2 eNRGy trial; the ability of our agreements with Caris, Foundation Medicine Inc., and Tempus Labs Inc. to identify NRG1+ patients and determine suitability of enrollment of these patients in our eNRGy trial and EAP; the ability of the collaboration with Caris to identify patients with NRG1+ cancer, for potential participation in the eNRGy trial and EAP; Caris' performance of tumor DNA and RNA molecular testing in this patient population having pancreatic cancer; myTomorrows' agreement to raise awareness of molecular screening offered by Merus for eligible patients, focusing on pancreatic cancer, to identify the presence of NRG1 fusions and to increase awareness of and potential enrollment in Merus' eNRGy clinical trial; the content and timing of potential milestones, updates, guidance, information, clinical trials and data readouts for our product candidates, including with respect to the Phase 1/2 eNRGy trial, Phase 1 trial for MCLA-158, and MCLA-129; the design and treatment potential of our bispecific antibody candidates, clinical study designs, the preclinical data for MCLA-129 showing that MCLA-129 inhibited the growth of tyrosine kinase resistant NSCLC cell lines and NSCLC tumors in xenograft models, our conducting IND-enabling studies of MCLA-129 for the treatment of various solid tumors in collaboration with Betta Pharmaceuticals, our global collaboration and license agreement with Incyte Corporation, potential development and commercialization of up to 11 bispecific and monospecific antibodies from our Biclonics® platform; and the impact of COVID-19. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the COVID-19 pandemic; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission, or SEC, on November 5, 2020, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected]
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UTRECHT, The Netherlands, and CAMBRIDGE, Mass., Oct. 12, 2020 (GLOBE NEWSWIRE) -- myTomorrows, a global health technology company, and Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced the expansion of their ongoing collaboration to raise awareness of screening opportunities for and recruitment of patients with neuregulin 1 (NRG1) fusion cancers.
Under a 2019 agreement, myTomorrows has been successfully providing support to eligible patients with NRG1 gene fusion cancers to participate in Merus' Early Access Program and to receive zenocutuzumab (Zeno, MCLA-128). Expanding the relationship, myTomorrows has agreed to raise awareness of the molecular screening offered by Merus focusing on pancreatic cancer, to identify the presence of NRG1 fusions and to increase awareness of and potential enrollment in Merus' eNRGy clinical trial. Patients recruited into the eNRGy clinical trial have cancers that harbor the NRG1 gene fusion, a rare and powerful driver of cancer cell growth found in lung, pancreatic and other solid tumor types.
"Our medical team engages daily with physicians and patients looking for treatment options for patients with high unmet medical need. This positions us well to bolster Merus' screening and trial enrollment efforts," said Michel van Harten, COO of myTomorrows. "Being able to apply our experience to help with diagnosis as well as raising awareness of Merus' offer of free molecular profiling to eligible patients with adenocarcinoma of the pancreas, is a natural extension of our mission to give patients more treatment options."
myTomorrows plans to leverage its expertise and ability to engage with patients, physicians and advocacy groups to raise awareness of molecular analysis for patients with adenocarcinoma of the pancreas. To further support clinical trial options for patients with adenocarcinoma of the pancreas harboring NRG1 fusion, for those eligible, Merus is offering to cover the cost of performing a full molecular analysis of the patient's tumor, including DNA and RNA sequencing, by an independent molecular profiling company.
"At present there are limited treatment options for patients with pancreatic cancer, and many cancers are not screened routinely for gene mutations," said Dr. Andrew Joe, Chief Medical Officer of Merus. "myTomorrows has been a welcome addition to our global efforts to raise awareness of molecular screening for patients with pancreatic cancer and to potentially identify and recruit patients harboring NRG1 fusions for our eNRGy trial. We look forward to continuing our work with the myTomorrows team in this broader capacity."
Merus is currently enrolling patients on the Phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus' trial website at www.nrg1.com or by calling 1-833-NRG-1234.
About NRG1 Fusions
The NRG1 gene encodes neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare, tumorigenic genomic events occurring in patients with certain cancers.About Patient Finding Programs
myTomorrows is committed to making drug development serve everyone better. This is done by engaging with both patients and their physicians to gain insights into needs and outcomes within the context of the pre-approval landscape. With these established relationships myTomorrows is very well positioned to assist bio-pharma companies of all sizes in their efforts to identify, engage with and offer patients the opportunity to participate in clinical research. In parallel to online activities such as disease awareness campaigns, myTomorrows also addresses physician-related barriers to Clinical Trial participation by acting as their trusted partner in information provision and proactive assistance with eligibility assessments as well as enrollment procedures.About myTomorrows
myTomorrows operates as an integrated end-to-end platform serving patients, healthcare providers, and drug developers. myTomorrows offers direct support as a single point of contact for patients with a life-threatening disease where there are limited or no standard approved therapies. These patients and their physicians are provided a personalized report detailing relevant Clinical Trials and pre-approval treatment options. myTomorrows also serves as a global partner for companies developing drugs to treat patients with unmet medical needs through program management at all phases, from patient identification for Clinical Trials to the distribution of investigational drugs around the world.
For more information please contact: [email protected]About Merus
Merus is a clinical-stage oncology company developing innovative full-length bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus' website, www.merus.nl and https://twitter.com/MerusNV.Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, myTomorrows' continued work under the 2019 agreement to provide support to eligible patients with NRG1 gene fusion cancers to participate in Merus' Early Access Program and to receive Zeno; myTomorrows agreement to raise awareness of the molecular screening offered by Merus focusing on pancreatic cancer, to identify the presence of NRG1 fusions, to increase awareness of and potential enrollment in Merus' eNRGy clinical trial; myTomorrow's engagement with physicians and patients looking for treatment options for patients with high unmet medical need and potential to bolster Merus' screening and trial enrollment efforts; myTomorrows plans to leverage its expertise and ability to engage with patients, physicians and advocacy groups to raise awareness around molecular analysis for patients with adenocarcinoma of the pancreas; Merus' offer, for eligible patients, to cover the cost of performing a full molecular analysis of the patient's tumor, including DNA and RNA sequencing, by an independent molecular profiling company; Merus' global efforts to raise awareness of molecular screening for patients with pancreatic cancer and to potentially identify and recruit patients harboring NRG1 fusions for our eNRGy trial; Merus and myTomorrow's continuing work in this broader capacity. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics® Triclonics™ and multispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the COVID-19 pandemic; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the Securities and Exchange Commission, or SEC, on May 11, 2020, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Merus Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected] myTomorrows Contact: [email protected]
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UTRECHT, The Netherlands, and CAMBRIDGE, Mass., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced that Bill Lundberg, M.D., President and Chief Executive Officer, will present a company overview at the 2020 Wedbush PacGrow Healthcare Conference on Wednesday, August 12, 2020 at 10:20 a.m. ET.
A live webcast of the presentation will be available on the Investors page of the Company's website, http://www.merus.nl. An archived presentation will be available on the Merus website for a limited time.
About Merus
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus' website, www.merus.nl and https://twitter.com/MerusNV.Merus Investor and Media Inquiries: Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 [email protected]
