Merus Announces Second Quarter 2017 Financial Results and Highlights Recent Progress
Merus Announces Second Quarter 2017 Financial Results and Highlights Recent Progress
UTRECHT, The Netherlands, Sept. 19, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced financial results for the second quarter ended June 30, 2017 and provided a corporate and clinical update.
"Merus has had a productive year to date, marked by progress in our work with Incyte and our other collaborators, the presentation at ASCO of positive Phase 1/2 data for our lead candidate MCLA-128 in the first of several indications, and progress among a stable of very exciting Biclonics®-based bispecific antibody therapy candidates toward and through the clinic," said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. "We believe that the potential of Merus' Biclonics® platform, which holds a number of key advantages over other bispecific antibody approaches, has only just begun to reveal itself."
"The balance of the year holds a number of key anticipated milestones, including initiating a Phase 2 trial of MCLA-128-based combinations in two metastatic breast cancer (MBC) populations, a decision on development of MCLA-128 in gastric, ovarian and endometrial cancers based on an expected data readout, progression of dose escalation in the Phase 1 trial evaluating MCLA-117 in acute myeloid leukemia (AML) under a Clinical Trial Authorization (CTA), filing of an Investigational New Drug (IND) submission for MCLA-117, and filing of a CTA for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer. We also look forward to initiating an IND-enabling study for MCLA-145, a bispecific antibody designed to bind to PD-L1 and to another undisclosed immunomodulatory target, a program that is part of our collaboration with Incyte," added Dr. Logtenberg.
Recent Clinical & Corporate Developments
In Part 2 of the Phase 1/2 MCLA-128 study in solid tumors, treatment was completed for a cohort of heavily pre-treated HER2+ MBC patients (n=11) using MCLA-128 as a single agent which resulted in an overall clinical benefit rate (defined as complete response plus partial response plus stable disease lasting at least 12 weeks) of 64%. With single agent activity established in MBC, the initiation of a Phase 2 clinical trial is anticipated in the fourth quarter of 2017 described further below under "Anticipated 2017 Milestones".
Merus and Incyte Corporation (NASDAQ:INCY) have advanced the first candidate from their global strategic research collaboration into an IND-enabling study. MCLA-145 is designed to bind to PD-L1 and to a second undisclosed immunomodulatory target to treat various solid tumors. Merus has full rights to develop and commercialize MCLA-145 in the United States and Incyte is responsible for its development and commercialization outside the United States.
Merus received a favorable ruling from the U.S. Court of Appeals for the Federal Circuit which affirmed that Regeneron Pharmaceuticals engaged in inequitable conduct during the patent prosecution of U.S. Patent No. 8,502,018, resulting in the patent's unenforceability.
Anticipated 2017 Milestones
During the fourth quarter, Merus expects to initiate a Phase 2, open label, multi-center international clinical trial to evaluate MCLA-128-based combinations in two MBC populations: (1) confirmed HER2-positive MBC patients (progressing on 2 to 4 anti-HER2 therapies, including TDM-1) who will receive MCLA-128 in combination with trastuzumab with and without chemotherapy, and (2) confirmed ER+/HER2-low MBC patients progressing on one or more prior endocrine therapies and CDK4/6 inhibitors who will receive MCLA-128 in combination with endocrine therapy. The trial is expected to enroll approximately 120 patients in total with approximately 60 patients targeted in each cohort.
Merus is continuing its dose escalation of the Phase I clinical trial for MCLA-117 in Europe and expects to submit an IND application to the U.S. Food and Drug Administration in the fourth quarter of 2017.
By the end of 2017, Merus expects to file a CTA for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer.
Second Quarter 2017 Financial Results
Merus ended the second quarter of 2017 with cash and cash equivalents of €215.8 million compared to €56.9 million at December 31, 2016.
Total revenue for the three months ended June 30, 2017 was €4.0 million compared to €1.1 million for the same period in 2016. Revenue is comprised primarily of amortization of the Incyte upfront license payment, research funding and income from grants on research projects.
Research and development costs for the three months ended June 30, 2017 were €8.4 million compared to €3.8 million for the same period in 2016. The increase in research and development costs quarter over quarter, reflects higher enrollment in our clinical trials and expansion of pre-clinical research efforts to support our collaboration with Incyte.
For the three months ended June 30, 2017, Merus reported a net loss of €21.8 million, or a loss of €1.12 per basic and diluted share, compared to a net loss of €4.9 million, or a loss of €0.40 per basic and diluted share, for the same period in 2016. The net loss for the three months ended June 30, 2017 includes approximately €12.0 million of unrealized foreign currency losses and approximately €3.3 million of non-cash, share option expenses.
Based on current operating plans, Merus expects that its current cash and cash equivalents balance will be sufficient to fund its research and development programs and operations well into 2019.
About Merus N.V.
Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics®, which are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have similar features as conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus' lead bispecific antibody candidate, MCLA-128, is expected to begin a Phase 2 combination trial in the second half of 2017 in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in Europe in gastric, ovarian, endometrial and non-small cell lung cancers. Merus' second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as MCLA-145 designed to bind to PD-L1 and a non-disclosed second immunomodulatory target, which is being developed in collaboration with Incyte Corporation. For additional information, please visit Merus' website, www.merus.nl.
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 statements regarding the potential of our Biclonics® platform, the timing of initiating the Phase 2 combination trial of MCLA-128 in MBC patients, the treatment potential of our Biclonics® candidates, and key anticipated milestones, including each statement under "Anticipated 2017 Milestones."
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® 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, 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 Incyte may fail to perform adequately under our collaboration; 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 existing and 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 Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on April 28, 2017, 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.
|Unaudited Condensed Consolidated Statement of Financial Position|
|(after appropriation of result for the period)|
| December 31,
|(euros in thousands)|
|Property, plant and equipment||1,057||648|
|Taxes and social security receivables||2,024||-|
|Trade receivables and other current assets||4,308||2,248|
|Cash and cash equivalents||215,788||56,917|
|Issued and paid-in capital||1,746||1,448|
|Share premium account||213,541||139,878|
|Deferred revenue, net of current portion||133,666||30,206|
|Taxes and social security liabilities||748||29|
|Other liabilities and accruals||5,434||3,650|
|Total equity and liabilities||223,629||72,310|
|Unaudited Condensed Consolidated Statement of Profit or Loss and Comprehensive Loss|
Three months ended
Six months ended
|(euros in thousands, except per share data)|
|Research and development costs||(8,420||)||(3,822||)||(15,427||)||(8,028||)|
|Management and administration costs||(3,492||)||(496||)||(7,694||)||(1,014||)|
|Total operating expenses||(14,189||)||(5,982||)||(27,241||)||(12,319||)|
|Total finance (expense) / income||(11,542||)||10||(22,086||)||38|
|Result before taxation||(21,704||)||(4,874||)||(43,014||)||(10,336||)|
|Income tax expense||(107||)||-||(118||)||-|
|Result after taxation||(21,811||)||(4,874||)||(43,132||)||(10,336||)|
|Other comprehensive income|
|Exchange differences on the translation of foreign operations||13||-||18||3|
|Total other comprehensive income for the period||13||-||18||3|
|Total comprehensive loss for the period||(21,798||)||(4,874||)||(43,114||)||(10,333||)|
|Basic (and diluted) loss per share||(1.12||)||(0.40||)||(2.27||)||(1.00||)|
|Weighted average shares outstanding|
|Basic (and diluted)||19,392,495||12,133,195||18,976,446||10,365,753|
+1 973 361 1546
+1 646 368 8014
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Merus N.V. via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Doc re. GE Files Form 8-K13.11.2018 17:30 | Pressemelding
FAIRFIELD, Conn., Nov. 13, 2018 (GLOBE NEWSWIRE) -- Company General Electric Company ISIN US3696041033 Symbol London: GEC | Paris: GNE Headline Doc re: GE files Form 8-k November 13, 2018 On November 13, 2018, General Electric Company (the "Company") filed a Form 8-K with the U.S. Securities and Exchange Commission ("SEC"), which has been submitted to RNS. It is also available on the SEC's website at http://www.sec.gov and on the Company's website at https://www.ge.com/investor-relations/events-reports. http://www.rns-pdf.londonstockexchange.com/rns/2365H_1-2018-11-13.pdf CONTACT: GE Jennifer Erickson +001 646 682 5620 firstname.lastname@example.org This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact email@example.com or visi
CloudGenix Named a Finalist in the 2018 CRN® Tech Innovator Awards13.11.2018 17:00 | Pressemelding
Company’s AppFabric Recognized in the 2018 Enterprise Networking Category SAN JOSE, Calif., Nov. 13, 2018 (GLOBE NEWSWIRE) -- CloudGenix announced today that CRN , ® a brand of The Channel Company, has been recognized as a finalist in the 2018 CRN Tech Innovator Awards. These annual awards honor standout hardware, software, and services that are moving the IT industry forward. In compiling the 2018 Tech Innovator Award list, CRN editors evaluated 300 products across 34 technology categories using several criteria, including technological advancements, uniqueness of features and potential to help solution providers solve end users' IT challenges. CloudGenix’s AppFabric took top honors in the Enterprise Networking category. CloudGenix AppFabric is a revolutionary software-defined wide area networking (SD-WAN) platform that allows businesses to integrate cloud and SaaS applications, create a secure application-defined fabric across any WAN transport, reduce operational cost and complexity
Atico Reports Reserves of 119 Million Pounds of Copper at the El Roble Mine13.11.2018 15:51 | Pressemelding
VANCOUVER, British Columbia, Nov. 13, 2018 (GLOBE NEWSWIRE) -- Atico Mining Corporation (the “Company” or “Atico”) (TSX.V: ATY | OTC: ATCMF) is pleased to announce the release of an updated NI 43-101 mineral resource and reserve estimate for the El Roble Mine located in Colombia. El Roble is currently in production at a rate of 850tpd and production guidance for the year is 20 million pounds of copper along with 9,850 ounces of gold in 2018. For the first three quarters of 2018, El Roble has produced 16 million pounds of copper and 8,400 ounces of gold or over 80% and 85% of annual forecast production for copper and gold respectively. “Our infill and mine vicinity exploration drilling at El Roble mine has been successful in replenishing mined resources since 2013. The maiden resource study at El Roble mine of 1.5 million tonnes of inferred resource has grown to 1.8 million tonnes of measured and indicated resources, while also having mined over 1 million tonnes of high-grade ore during
New VANTIQ Pronto Drives Modern Event-Driven Systems13.11.2018 15:00 | Pressemelding
VANTIQ Pronto Dynamic Advanced Event Broker™ enables organizations with real-time business responsiveness across enterprise, cloud and edge events PONTE VEDRA BEACH, Fla., Nov. 13, 2018 (GLOBE NEWSWIRE) -- Today, at the nGage Enterprise Transformation Exchange Summit, VANTIQ announced VANTIQ Pronto, the industry’s first dynamic “Advanced Event Broker” (AEB). IT leaders from across the U.S. learned how Pronto is designed to deliver unique advantages for companies looking to power modern, event-driven applications with the real-time business responsiveness, intelligence and agility required for digital transformation initiatives. VANTIQ Pronto will be generally available to developers on November 30 at no charge for up to 2 million event messages in production per month. According to Gartner, “Application leaders engaged in digital transformation must include event-driven computing in their portfolio of skills and technology, including the key related responsibilities for event brokering
New PubMatic Research Reveals Mobile Header Bidding Volumes Nearly Double as the Technology Extends to In-app Environments13.11.2018 15:00 | Pressemelding
PubMatic releases Q3 2018 QMI report, highlighting key trends that impact mobile advertising growth REDWOOD CITY, Calif., Nov. 13, 2018 (GLOBE NEWSWIRE) -- PubMatic, the publisher-focused sell-side platform (SSP) for an open digital media future, today released its third Quarterly Mobile Index (QMI) of 2018. The report includes key insights around the growth in mobile app advertising, highlighting trends in mobile video, header bidding and the expansion of cross-channel monetization. The newly released findings will guide publishers and buyers toward smarter programmatic strategy and projected future mobile opportunities. Advertisers are expected to spend more than $180 billion on mobile advertising in 2019 (eMarketer) and so it is imperative to understand where the growth is taking place to plan accordingly. PubMatic’s Q3 2018 QMI Report reveals the top three trends to watch: Mobile Video Reached A Milestone - Advertiser interest is driving global mobile video ad spend growth, creatin
Velox Completes $32M Investment Round, Accelerating Market Penetration and Further Innovating Industrial Direct-to-Shape Digital Printing13.11.2018 14:01 | Pressemelding
A group of financial and strategic investors back Velox's commercially available, market-proven, disruptive technology ROSH HA'AYIN, Israel, Nov. 13, 2018 (GLOBE NEWSWIRE) -- Today, Velox, the leading developer of the world’s only mass production direct-to-shape (DTS) digital printing technology, completed a $32 million funding round. The round was co-led by JAL Ventures and O.R.T. Technologies Ltd., and joined by strategic investors ALTANA, Evonik as well as existing investors Michael Ilan Management & Investments Ltd. (MILMI), Dr. Shlomo Shamir, and additional private investors. With equipment commercially deployed, and multiple high-value strategic global accounts secured, Velox is seen as an industry standout. Velox’s uniquely formulated inks and proprietary printing process enables it to take digital printing from the domain of special-editions-only into the mass packaging decoration mega market. Investor Quotes: “Our investment in Velox is an expression of our strategic and on-go
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom