MRUS Merus N.V.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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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-158
Colorectal cancer
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Phase 1
Phase 1
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Phase 1 trial ongoing.
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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
|
Phase 1 dosing has commenced - May 9, 2019.
|
Latest News
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., Feb. 01, 2021 (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., Chief Executive Officer, will participate in the following investor conferences:
Guggenheim Healthcare Talks 2021 Oncology Days (Fireside chat): Friday, Feb. 12 at 10:30-10:55 a.m. ET
LifeSci Partners Precision Oncology Day (Presentation): Wednesday, Feb. 17 at 10:30-10:55 a.m. ET
2021 SVB Leerink Global Healthcare Conference (Presentation): Friday, Feb. 26 at 8:40-9:10 a.m. ET
The live webcasts of the presentations will be available on the Investors page of the Company's website, https://ir.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, http://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] Kathleen Farren Merus N.V. Communications Specialist [email protected]
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UTRECHT, The Netherlands, and CAMBRIDGE, Mass., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS) ("Merus", "we" and "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced the pricing of an underwritten public offering of 4,848,485 common shares at a public offering price of $24.75 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $120 million. In addition, Merus granted the underwriters a 30-day option to purchase up to an additional 727,272 common shares at the public offering price, less the underwriting discounts and commissions. All of the shares in the offering are to be sold by Merus.
The offering is expected to close on or about January 25, 2021, subject to customary closing conditions.
Merus intends to use the net proceeds from the offering to advance the clinical development of its product candidates, for preclinical research and technology development, and for working capital and general corporate purposes.
Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the offering. Kempen & Co is acting as lead manager for the offering. H.C. Wainwright & Co. and Roth Capital Partners are acting as co-managers for the offering.
The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (SEC) on August 20, 2019 as a registration statement on Form F-3 and amended by a post-effective amendment to Form F-3 on Form S-3 filed on April 30, 2020, which was declared effective by the SEC on May 5, 2020. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a "prospectus" for the purposes of (i) the Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been reviewed by any competent authority in any member state in the European Economic Area and (ii) the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation") and has not been reviewed by the Financial Conduct Authority in the United Kingdom. A preliminary prospectus supplement to the prospectus describing the terms of the offering was filed with the SEC on January 19, 2021. A final prospectus supplement will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by e-mail at [email protected] or SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6132, or by e-mail at [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
This press release is an advertisement and not a prospectus within the meaning of either the Prospectus Regulation or the UK Prospectus Regulation.
European Economic Area (EEA):
In relation to each member state of the EEA (each, a "Relevant State"), no shares of the Company have been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication of a prospectus in relation to the Company's shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that offers of the Company's shares may be made to the public in that Relevant State at any time under the following exemptions under the Prospectus Regulation:
- to any legal entity which is a qualified investor as defined under Article 2 of the Prospectus Regulation;
- to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the joint bookrunners; and
- in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
provided that no such offer of the Company's shares shall require us or any of our representatives to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation and each person who initially acquires any shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed to and with each of the representatives and us that it is a "qualified investor" as defined in the Prospectus Regulation.
For the purposes of the above, the expression an "offer of shares to the public" in relation to any shares in any Relevant State means the communication in any form and by means of sufficient information on the terms of the offer and the shares to be offered so as to enable an investor to decide to purchase shares.
United Kingdom:
In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with persons who are (a) "qualified investors" (as defined in the UK Prospectus Regulation) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act (Financial Promotion) Order 2005, as amended (the Order), and/or (ii) who are high net worth entities falling within Article 49(2)(a) to (d) of the Order or (b) persons to whom it may otherwise be lawfully communicated (all such persons under (a) and (b) together being referred to as "relevant persons"). The securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.
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.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 completion of the proposed offering, the anticipated gross proceeds from the offering and our intended use of any proceeds from the offering. 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 September 30, 2020 filed with the SEC on November 5, 2020, in the prospectus supplement related to the offering, and in 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] Kathleen Farren Merus N.V. Communications Specialist 617-401-4499 [email protected]
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS) ("Merus", "we" and "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced the launch of a proposed underwritten public offering of up to $60 million of its common shares. All of the common shares are being offered by Merus. In addition, Merus expects to grant the underwriters a 30-day option to purchase up to an additional $9 million of its common shares. The offering is subject to market conditions and other closing conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Merus intends to use the net proceeds from the offering to advance the clinical development of its product candidates, for preclinical research and technology development, and for working capital and general corporate purposes.
Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the offering.
The offering will be made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (SEC) on August 20, 2019 as a registration statement on Form F-3 and amended by a post-effective amendment to Form F-3 on Form S-3 filed on April 30, 2020, which was declared effective by the SEC on May 5, 2020. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a "prospectus" for the purposes of (i) the Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been reviewed by any competent authority in any member state in the European Economic Area and (ii) the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation") and has not been reviewed by the Financial Conduct Authority in the United Kingdom. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected] or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
This press release is an advertisement and not a prospectus within the meaning of either the Prospectus Regulation or the UK Prospectus Regulation.
European Economic Area (EEA):
In relation to each member state of the EEA (each, a "Relevant State"), no shares of the Company have been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication of a prospectus in relation to the Company's shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that offers of the Company's shares may be made to the public in that Relevant State at any time under the following exemptions under the Prospectus Regulation:
- to any legal entity which is a qualified investor as defined under Article 2 of the Prospectus Regulation;
- to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the joint bookrunners; and
- in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
provided that no such offer of the Company's shares shall require us or any of our representatives to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation and each person who initially acquires any shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed to and with each of the representatives and us that it is a "qualified investor" as defined in the Prospectus Regulation.
For the purposes of the above, the expression an "offer of shares to the public" in relation to any shares in any Relevant State means the communication in any form and by means of sufficient information on the terms of the offer and the shares to be offered so as to enable an investor to decide to purchase shares.
United Kingdom:
In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with persons who are (a) "qualified investors" (as defined in the UK Prospectus Regulation) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act (Financial Promotion) Order 2005, as amended (the Order), and/or (ii) who are high net worth entities falling within Article 49(2)(a) to (d) of the Order or (b) persons to whom it may otherwise be lawfully communicated (all such persons under (a) and (b) together being referred to as "relevant persons"). The securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.
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.
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 completion, timing and size of the proposed offering, expectations with respect to granting the underwriters a 30-day option to purchase additional common shares and our intended use of any net proceeds from the offering. 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 September 30, 2020 filed with the SEC on November 5, 2020, in the preliminary prospectus supplement related to the offering, and in 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] Kathleen Farren Merus N.V. Communications Specialist 617-401-4499 [email protected]
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INDIANAPOLIS and UTRECHT, The Netherlands, Jan. 19, 2021 /PRNewswire/ -- Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE:LLY), and Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing multi-specific antibodies, today announced a research collaboration and exclusive license agreement that will leverage Merus' proprietary Biclonics® platform along with the scientific and rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies.
Under the terms of the agreement, Merus will lead discovery and early stage research activities while Loxo Oncology at Lilly will be responsible for additional research, development and commercialization activities. Merus will receive an upfront cash payment of $40 million, as well as an equity investment by Lilly of $20 million in Merus common shares. Merus is also eligible to receive up to $540 million in potential development and commercialization milestones per product, for a total of up to approximately $1.6 billion for three products, as well as tiered royalties ranging from the mid-single to low-double digits on product sales should Lilly successfully commercialize a therapy from the collaboration.
"CD3-engaging bispecific antibodies are rapidly becoming one of the most transformative immune-modulating modalities used to treat cancer. We expect these therapies will become an important component of the Loxo Oncology at Lilly biologics strategy," said Jacob Van Naarden, chief operating officer of Loxo Oncology at Lilly. "Merus has built a differentiated platform and one that we believe can enable us to create bispecific antibody therapies with wider therapeutic indexes than those available today. We look forward to working closely with Merus to develop new potential medicines for patients with cancer."
"The collaboration with Loxo Oncology at Lilly and their world class research capabilities opens up exciting possibilities for Merus' Biclonics® platform," said Bill Lundberg, MD., President and Chief Executive Officer at Merus. "Our CD3 T-cell engager platform includes over 175 novel and diverse anti-CD3 common light chain antibodies across a wide range of affinities and attributes and enables functional screening of large libraries for optimal performance. We look forward to working together with Loxo Oncology at Lilly to define a new generation of medicines to treat cancer."
This transaction is subject to customary closing conditions. This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly's 2021 non-GAAP earnings per share guidance as a result of this transaction.
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.About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo Oncology at Lilly brings together the focus and spirit of a biotech with the scale and resources of large pharma, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com. C-LLYMerus 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, benefits of a collaboration between Loxo Oncology at Lilly and Merus; whether and when Merus will receive any future payment under the collaboration, including milestones or royalties, and the amounts of such payments; whether any programs under the collaboration will be successful; the potential of Merus' CD3 T-cell engager platform and capacity to functionally screen large libraries of engager molecules for optimal performance holding potential to define next-generation medicines to treat cancer. 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 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.
Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of a collaboration between Lilly and Merus, Lilly's biologics strategy, and potential payments to Merus in connection with the collaboration, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the collaboration, that the collaboration will yield commercially successful products, or that Lilly will execute its strategy as expected. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.Refer to:
Mark Taylor; [email protected]; (317) 276-5795 (Lilly Media)
Kevin Hern; [email protected]; (317) 277-1838 (Lilly Investors)
Jillian Connell; [email protected]; (617)-955-4716 (Merus)
View original content to download multimedia:http://www.prnewswire.com/news-releases/lilly-and-merus-nv-announce-collaboration-to-discover-novel-t-cell-re-directing-bispecific-antibodies-301210513.htmlSOURCE Eli Lilly and Company
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UTRECHT, The Netherlands, and CAMBRIDGE, Mass., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™), today announced collaborations with nationwide medical organizations in the Netherlands and Japan to raise awareness of the eNRGy trial and to provide molecular screening opportunities for patients with cancers that may have neuregulin 1 (NRG1) fusions. In the collaborations, Merus has agreed to support access to next generation sequencing for eligible patients with pancreatic adenocarcinoma in the Netherlands, and pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC) in Japan, aimed to identify the presence of NRG1 fusions and raise awareness of potential paths to enrollment in Merus' Phase 1/2 eNRGy trial of bispecific antibody zenocutuzumab (Zeno). The collaborating organizations in the two countries are:
- Erasmus University Medical Center Rotterdam (Erasmus MC) in the Netherlands has agreed to perform a nationwide campaign, in affiliation with the Dutch Pancreatic Cancer Group (DPCG), to raise awareness of next generation genome screening offered by Merus for eligible patients with a diagnosis of pancreatic adenocarcinoma at all 17 pancreatic cancer centers in the Netherlands, and availability of the eNRGy trial for eligible patients. Erasmus MC, based in Rotterdam, is the largest University Medical Center in the Netherlands and is devoted to providing outstanding care, facilitating world-class education and conducting pioneering research.
- National Cancer Center (NCC) Japan has agreed to provide RNA sequencing, funded in part by Merus, for eligible patients with pancreatic adenocarcinoma and patients with NSCLC to identify NRG1 fusions. Patients with pancreatic adenocarcinoma will be directed to the SCRUM-Japan GI-SCREEN program. Patients with NSCLC will be directed to the LC-SCRUM-Asia program. Both programs are part of an Asian genome screening platform operating within institutions participating in the GI-SCREEN and LC-SCRUM-Asia programs, including the NCC Hospital East (NCCHE) and approximately 215 other institutions in Japan, to identify patients with targetable gene alterations for the development of novel targeted therapies. NCC Japan, established in 1962, is a leading medical institution in cancer treatment and research in Japan. NCCHE, established in 1992, is one of the leading specialized cancer hospitals in Japan, treating over 9,000 new patients each year. NCCHE has been promoting the development of innovative cancer medicines and medical devices, including first-in-human trials of new cancer medicines and investigator-initiated trials.
"Merus is supporting a broad molecular screening effort for patients who are not routinely screened for gene mutations," said Dr. Andrew Joe, Chief Medical Officer of Merus. "Partnering with prestigious academic institutions and national cooperative groups of investigators dedicated to the treatment of cancer is a strategic effort we are undertaking as we seek to advance enrollment in our eNRGy clinical trial to explore the potential for Zeno to become a compelling new treatment option for cancer patients with NRG1 fusions."
About the eNRGy Clinical Trial
Merus is currently enrolling patients in 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 Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics® that utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors. Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.Learn more about Zeno Dock & Block® at https://merus.nl/technology/.
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.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 potential of collaborations with Erasmus MC and NCC to raise awareness of the eNRGy trial and to provide molecular screening opportunities for patients with cancers that may have NRG1 fusions; the aim of identifying the presence of NRG1 fusions and potential paths to enrollment in Merus' Phase 1/2 eNRGy trial; any results from the strategic effort Merus is undertaking through these agreements to seek to advance enrollment in our eNRGy clinical trial to explore the potential of Zeno to become a compelling new treatment option for cancer patients with NRG1 fusions. 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] Kathleen Farren Merus N.V. Communications Specialist [email protected]
- Erasmus University Medical Center Rotterdam (Erasmus MC) in the Netherlands has agreed to perform a nationwide campaign, in affiliation with the Dutch Pancreatic Cancer Group (DPCG), to raise awareness of next generation genome screening offered by Merus for eligible patients with a diagnosis of pancreatic adenocarcinoma at all 17 pancreatic cancer centers in the Netherlands, and availability of the eNRGy trial for eligible patients. Erasmus MC, based in Rotterdam, is the largest University Medical Center in the Netherlands and is devoted to providing outstanding care, facilitating world-class education and conducting pioneering research.