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906 Posts, Pagina: « 1 2 3 4 5 6 7 8 9 10 ... 42 43 44 45 46 » | Laatste
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KeepTHeFaith
0
Huidige te lage koers is een gevolg van de winstnemingen die op gang zijn gekomen nadat de koers te hoog was opgelopen. Er is nu wel een vonkje nodig om het vuur weer aan te wakkeren.
KeepTHeFaith
0
Het gunstig beursklimaat wakkert het vuur aan. De pan begint al behoorlijk warm te worden.
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onder de 25 die incyte betaald blijft het aantrekkelijk en zijn zo weer terug op de 30.
Pl4
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Aandeel lijkt te bouncen. Op naar publicatie van afronding deal Incyte en ontvangst betaling van 200m usd.
Pl4
1
ir.merus.nl/phoenix.zhtml?c=254206&am...

Aan het eind van Q1 2017 inmiddels ca 256 miljoen cash op een beurswaarde van 330 m usd..

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Deel 1

Merus Announces Fourth Quarter and Full Year 2016 Financial Results and Corporate Developments

UTRECHT, The Netherlands, April 28, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced financial results for the fourth quarter and full year ended December 31, 2016 and provided a corporate and clinical update.

"Last year was a transformative period for Merus marked by the signing of a global collaboration with Incyte, a deal that brings a world class collaborator to Merus and significant strength to our balance sheet, and that we believe will significantly advance our proprietary candidates into and through the clinic,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “We anticipate that 2017 will be distinguished by several important data points for our wholly owned clinical-stage pipeline, beginning with the presentation of data from lead compound MCLA-128, an ADCC-enhanced Biclonics® that binds to HER2 and HER3, at the upcoming ASCO annual meeting. We expect to follow this by the clinical advancement of MCLA-117, with initial phase 1 results in patients with AML expected in the second half of the year, then we anticipate submitting a Clinical Trial Application (CTA) for a planned Phase 1/2 clinical trial of MCLA-158 in patients with colorectal cancer by year end.”

Recent Developments

In March 2017, Merus announced that it was named BioCapital Europe Company of the Year for 2017. The Company of the Year Award is given to the organization that has undergone the most substantial transformation in the previous year and has experienced a breakthrough with respect to its technology, clinical development, partnering, IPO and/or M&A activities.

In January 2017, Merus and the Institute for Research in Biomedicine (IRB) Barcelona, a research center devoted to understanding fundamental questions about human health and disease, entered into a research collaboration to jointly develop novel agents that target the tumor microenvironment. The research collaboration will combine Merus’ Biclonics® technology platform for the discovery and development of therapeutic bispecific antibodies and IRB’s unique cell and animal models to evaluate therapeutic targeting of stromal cells that support tumor growth and metastasis.

In December 2016, Merus and Incyte (NASDAQ:INCY) announced a global, strategic collaboration agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform. The agreement grants Incyte certain exclusive rights for up to eleven bispecific antibody research programs, including two of Merus’ current preclinical immuno-oncology discovery programs. Under the terms of the collaboration, which closed in January 2017, Incyte paid Merus an upfront payment of $120 million and purchased 3.2 million common shares of Merus at $25 per share, for a total equity investment of $80 million. For one current preclinical program, Merus will retain all rights to develop and commercialize an approved product in the United States. Merus also has the option to co-fund development of product candidates arising from two other programs. For the other eight programs, Merus is eligible to receive potential development, regulatory and sales milestone payments of up to $350 million per program, for an aggregate milestone opportunity of approximately $2.8 billion if all milestones are achieved across all eight programs in all territories, in addition to tiered royalties ranging from 6 to 10 percent on global sales.

In November 2016, Merus received favorable rulings for its European patent EP 2147594 B1 by the Opposition Division of the European Patent Office and by the Trial Board of the Japanese Patent Office for its Japanese counterpart JP 5749161. Both patents cover Merus’ genetically-modified mice and their use to produce common light chain human monoclonal antibodies.

In November 2016, Merus was awarded a grant of €0.5 million from EUREKA Eurostars with Aquila BioMedical Ltd. to jointly develop immunological assays supporting the selection of potent bispecific antibodies that positively modulate tumor immunity with superior potency and lower toxicity compared to existing drugs.

Pl4
0
Deel 2

Anticipated 2017 Milestones

Clinical data on MCLA-128 will be presented at the 2017 ASCO Annual Meeting taking place on June 2-6, 2017 in Chicago. The abstract is entitled, “First in human phase 1/2 study of MCLA-128, a full length IgG1 bispecific antibody targeting HER2and HER3; final phase 1 data and preliminary activity in HER2+ metastatic breast cancer (mBC).”

An Investigational New Drug application to the U.S. Food and Drug Administration of MCLA-117 for a Phase 1 trial is planned during the second half of 2017.

During the second half of 2017, Merus expects to report topline data from its Part 2 of Phase 1/2 monotherapy trial of MCLA-128 in patients with solid tumors in multiple indications.

During the second half of 2017, Merus expects to report interim results from its Phase 1 clinical trial evaluating MCLA-117 in patients with AML.

By the end of 2017, Merus expects to file a CTA for a planned Phase 1/2 clinical trial of MCLA-158 in patients with colorectal cancer.

Fourth Quarter 2016 Financial Results
(Euros in millions, except as indicated)

Total revenue for the three months ended December 31, 2016 was €1.1 million compared to €0.4 million for the same period in 2015. Revenue is comprised primarily of research funding, milestone payments and income from grants on research projects.

Research and development expenses for the three months ended December 31, 2016 were €7.5 million compared to €4.8 million for the same period in 2015.

For the three months ended December 31, 2016, Merus reported a net loss of €30.7 million, or €(1.91) per share (basic and diluted), compared to a net loss of €6.6 million, or €(0.77) per share (basic and diluted), for the same period in 2015. The net loss for the three months ended December 31, 2016 includes a non-cash charge of €19.2 million for the accounting impact of a financial derivative related to the obligation to deliver shares to Incyte in 2017.

Full Year 2016 Financial Results
(Euros in millions, except as indicated)

Total revenue for the full year 2016 was €2.7 million compared to €2.0 million for the full year 2015. Revenue is comprised primarily of research funding, milestone payments and income from grants on research projects.

Research and development expenses for the full year 2016 were €19.0 million compared to €16.4 million for the full year 2015.

For the full year 2016, Merus reported a loss of €47.2 million, or €(3.57) per share (basic and diluted), compared to a net loss of €23.2 million, or €(3.95) per share (basic and diluted) for the full year in 2015. The loss for the full year 2016 includes a non-cash charge of €19.2 million for the accounting impact of a financial derivative related to the obligation to deliver shares to Incyte in 2017.

Merus ended the 2016 full year with cash and cash equivalents of €56.9 million. On January 23, 2017, the Company closed its global strategic research collaboration with Incyte Corporation, which included an upfront payment of $120 million and the purchase by Incyte of 3.2 million of Merus’ common shares for $80 million.

About MCLA-128
MCLA-128 is designed to block HER3/heregulin dependent tumor growth and survival as well as enhance immune-mediated killing of tumors. MCLA-128 employs a ‘dock and block’ mechanism in which the mode of HER2 receptor binding orientates the HER3 binding arm to effectively block oncogenic signaling through the HER2:HER3 heterodimer even under high heregulin concentrations. In addition, MCLA-128 is engineered for enhanced ADCC in order to recruit and activate immune effector cells to directly kill the tumor.

About MCLA-117
MCLA-117 is a Biclonics® that is designed to bind to CD3 expressed by T-cells and CLEC12A expressed by acute myeloid leukemia (AML) tumor cells and stem cells. In preclinical studies, MCLA-117 has been shown to recruit and activate the immune system’s own T-cells to kill AML tumor cells and stem cells.

About MCLA-158
MCLA-158 is an ADCC-enhanced Biclonics® being developed for the treatment of colorectal cancer and other solid tumors. MCLA-158 is designed to bind to Lgr5 and EGFR expressing cancer stem cells, block growth and survival pathways and enhance the recruitment of immune effector cells to directly kill cancer stem cells that persist in solid tumors causing relapse and metastasis.
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PI4 dank en zoals je zegt is de aanwezige cash en huidige koers een mooie oppurtunity en komen er beslist wat interesting milestones aan...
KAKO
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quote:

fly like an eagle schreef op 2 mei 2017 om 13:00:


PI4 dank en zoals je zegt is de aanwezige cash en huidige koers een mooie oppurtunity en komen er beslist wat interesting milestones aan...


Inderdaad. Het is een kwestie van tijd voordat Merus aan de volgende opmars begint. Ik heb mijn positie in ieder geval vergroot! Merus, MDX en Galapagos moeten het voor mij gaan doen. Na de lock up verwacht ik een overname van Gala door Gilead. Of er komt voor die tijd nog een vijandig bod van een andere partij. Al zijn Merus en MDX ook wel overnamekandidaten, hoop ik dat deze in ieder geval tot eind 2018 zelfstandig blijven.
KeepTHeFaith
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quote:

fly like an eagle schreef op 4 mei 2017 om 17:27:


Yep heb deze ook maar ook Argenix en Ablynx

Niet meer in Mdx?
Pl4
1
Bron: seekingalpha.com/article/4069869-meru...

Merus: A Buy On Lucrative Incyte Partnership And 2017 Catalysts
May 5, 2017 6:24 PM ET|

About: Merus (MRUS), Includes: INCY
Jonathan Faison

Shares have doubled over the past year while the recent dip could be offering investors a solid entry point.

Terms of Incyte partnership are quite generous and lend credibility to the story.

Biclonics technology could create substantial value for shareholders over the long term.

Data readouts throughout the year provide important catalysts.

Large cash position provides a decent cushion while risks include disappointing data and clinical setbacks.

Shares of Merus (NASDAQ:MRUS) have doubled over the past year while the 30% dip since the beginning of March has left them hovering around the $20 level, an area of prior support.

MRUS Chart

MRUS data by YCharts

The small biotech firm first jumped on my radar after announcing a collaboration with Incyte (NASDAQ:INCY) back in December, one with generous terms in which INCY paid $120 million upfront and a common share purchase of $80 million. Incyte in return received exclusive rights for up to 11 bispecific antibody research programs utilizing Merus's Biclonics technology, which included two preclinical immuno-oncology candidates.

The generous terms of the deal continue; Merus got to retain all the rights to develop and commercialize products in the United States while Incyte received rights to the rest of the world. Both companies will have to pay the other royalties in the 6% to 10% range on net sales in their territories.

Also, Merus retained the option to co-fund development from two other programs in which it would be responsible for 35% of development costs and receive 50% share of US profits and losses along with tiered royalties on ex-US sales.

Importantly, Incyte will be funding all development and commercialization activities while Merus could receive up to $350 million in milestone payments per program, totaling $2.8 billion across all eight other programs in all territories plus tiered royalties.

Lastly, Merus has retained rights to both drug candidates in the clinic and MCLA-158, as well as potential programs stemming from its technology platform outside of the Incyte agreement.

Digging Deeper

Biclonics are bispecific, full-length human IgG antibodies which have the potential for improved tumor cell killing activity than conventional monoclonal antibodies. Additionally, they tend to have lower toxicity compared to combinations of monoclonal antibodies.

Figure 2: Potential for less toxicity (Source: Corporate presentation)

Distinguished management greatly adds to the bull case in my opinion, with CEO Dr. Ton Logtenberg and CSO Dr. Mark Throsby hailing from Crucell (acquired by Johnson & Johnson (NYSE:JNJ)) while CBO Dr. Hui Liu and CMO Dr. L. Andres Sirulnik served in related capacities at Novartis (NYSE:NVS).

The company's lead candidate MCLA-128 targets HER2 and HER3 while the next most advanced program is directed toward CD3 and CLEC12A.

Figure 3: Pipeline (Source: Corporate presentation)

MCLA-128 is being positioned for use as a single agent or in combination with HER-targeting biologics, small molecule drugs or chemotherapy. Preclinical data has hinted that the drug candidate more effectively inhibits heregulin-driven cancer cell growth and the growth of cell lines resistant to HER2 target therapies than other conventional options.

A two-part phase 1 trial has enrolled 28 patients with solid tumors and, thus far, no dose-limiting toxicities have been observed and drug-related adverse events were mild to moderate (grade 1 and 2). Evidence of activity in heavily pre-treated patients has been observed, including those who have progressed prior on chemotherapy and HER2 directed therapies.

In the expansion cohort, the following are being enrolled:

Metastatic breast cancer patients (n=20) who have progressed on two HER2 directed therapies and chemo.
Ovarian cancer patients (n=20) who have progressed to platinum-based therapies.
Endometrial cancer patients (n=20) who have progressed to platinum-based therapies.
Metastatic gastric cancer patients (n=20) who have progressed to trastuzumab/chemotherapy.

As for MCLA-117 in AML, in May last year, the company initiated a trial targeting patients with relapsed or refractory disease as well as newly diagnosed, untreated patients older than 65 who are not candidates for standard therapy. Target CLEC12A is expressed by tumor cells of 90% to 95% of patients with AML, 85% of patients with MDS, and also expressed by AML tumor stem cells.

Important Near- to Medium-Term Catalysts

Interim results from part 2 of phase 1/2 trial of MCLA-128 in the first quarter (OTC:ASCO).
Interim results expected from part 1 of MCLA-117 trial in AML in the second half of the year.
Top-line results expected from part 2 of MCLA-128 trial in multiple indications in the second half of the year.

Other Information

For year-end 2016, the company reported cash and equivalents of €56.9 million, which don't include the $120 million upfront payment from Incyte or the $80 million purchase of common shares. Well over half of the company's valuation is backed by its cash position while dilution in the medium term is no longer a concern due to its considerable operational runway.

I'm not the only one who sees potential here - Baker Bros., Franklin Resources, Tekla Capital Management and others own significant stakes.

I believe shares of this Netherlands-based biotech are a speculative buy as there are several important catalysts this year in addition to several candidates entering the clinic. As the pipeline progresses and if early data proves promising, we should see valuation increase as Wall Street gives this story more attention.

Importantly, instead of chasing the run-up in shares as many did after the Incyte partnership, we chose to wait before initiating coverage for a reversion in share price. If there had been more near-term catalysts at the time, perhaps it would have merited an initial pilot position at that point; it's a good example of investors needing to have sense of when to jump in and when wait patiently for entry.

The main risks at this point are disappointing results and clinical setbacks. Also, keep in mind the share float is quite small (less than 1 million I believe), so trading could be quite volatile as well as the difference between the bid and ask (use limit orders only). This could also work in investors' favor in the event of an ASCO run-up or positive early data
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Thx en had deze ontvangen en helder verhaal. Snpa de daling weer onder de 19 niet goed maar als Incyte 25 heeft betaald kan ik me niet voorstellen dat we die weer gaan zien of dat we over 1-2 jaar Gala achterna gaan.
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UTRECHT, The Netherlands , May 09, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced that the Annual General Meeting of Shareholders will be held on Wednesday, May 24 , 2017 at 8:00 am CET, at the Hilton Hotel Amsterdam Airport Schiphol , Schiphol Boulevard 701, 1118 BN Schiphol, The Netherlands .

All relevant documents and information for the meeting, including the notice and agenda, are available in the ‘Investor Relations' section of Merus website (www.merus.nl) under "Financial Information."

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® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have several of the same features of conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus' lead bispecific antibody candidate, MCLA-128, is being evaluated in a Phase 1/2 clinical trial in Europe as a potential treatment for HER2-expressing solid tumors. Merus' second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. Merus 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, and Biclonics® designed to bind to various combinations of immunomodulatory molecules, including PD-1 and PD-L1.
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Merus Announces Promising Results from MCLA-128 Phase 1/2 Study in Metastatic Breast Cancer

Results to be presented at the 2017 American Society of Clinical Oncology Annual Meeting

Phase 2 clinical trial to be initiated in second half of 2017 exploring two metastatic breast cancer populations: HER2-positive patients and hormone receptor-positive/HER2-low patients

UTRECHT, The Netherlands, May 17, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced the results of their first-in-human Phase 1/2 study of MCLA-128 in solid tumors, including final Phase 1 data and promising preliminary activity in patients with HER2-positive metastatic breast cancer (MBC) from the Phase 2 portion of the trial. MCLA-128 is a full-length IgG bispecific antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity targeting HER2 and HER3 receptors. The results will be presented in a poster session on the morning of June 5, 2017 at the American Society of Clinical Oncology (ASCO) Annual Meeting.

In the Phase 1 portion of the Phase 1/2 study, the recommended Phase 2 dose (RP2D) for future studies with MCLA-128 was established as 750 mg every 3 weeks, based on safety and pharmacokinetic data. The Phase 2 portion of the study is ongoing, exploring selected metastatic indications including breast, endometrial, ovarian, gastric and non-small cell lung cancers. MCLA-128 was well tolerated, with the ongoing Phase 2 portion confirming the safety profile seen in the dose escalation cohort. The most frequent adverse events observed were mild (G1/G2) infusion-related reactions and gastrointestinal toxicities. No clinically significant cardiotoxicity was reported.

As part of the ongoing study, a cohort of 11 HER2-positive MBC patients has been treated with single agent MCLA-128 (9 patients at RP2D and 2 patients at 480 mg q3 weeks from part 1). These MBC patients were all heavily pretreated, having received a median of 6 prior lines of metastatic therapy, all having 2-5 prior HER2 inhibitor therapies, and some of the patients with outright disease progression to the last line of therapy. One MBC patient achieved a confirmed partial response (>8+ months) and 7 had stable disease (including 4 sustained stabilizations lasting =5 months). The clinical benefit rate (complete and partial responses plus stable disease lasting at least 12 weeks) among the cohort of MBC patients was 64% (7/11). Evaluation of additional MBC patients and other indications is ongoing.

With single agent activity established in MBC, Merus also announced today plans to initiate a Phase 2, open-label, multicenter, international clinical study to evaluate MCLA-128-based combinations in two MBC populations: 1) confirmed HER2-positive MBC patients (progressing on anti-HER2 therapies including TDM-1) who will receive MCLA-128 in combination with trastuzumab and chemotherapy, and 2) confirmed hormone receptor positive status and HER2-low (IHC HER2 1+ or 2+ and FISH negative for HER2 amplification) MBC patients progressing on hormone therapies and CDK4/6 who will receive MCLA-128 in combination with fulvestrant. In addition to these early clinical results, study of MCLA-128 in these combinations and populations is supported by activity observed in preclinical models. This Phase 2 study is expected to be launched in Europe and the US in the second half of 2017.

“These clinical results demonstrate that single agent MCLA-128 is active and well tolerated in heavily pretreated metastatic breast cancer patients,” said Professor Josep Tabernero, MD, PhD, Head of Medical Oncology and the Institute of Oncology at Vall d'Hebron University Hospital. “This positions MCLA-128 as a promising agent for further development as combination therapy in the treatment paradigm of metastatic breast cancer. I look forward to seeing how these results translate in the planned Phase 2 combination studies.”

“With demonstrated activity in an aggressive disease population, our goal now is to understand where MCLA-128, in combination with current standards of care, can address unmet needs in this disease and deliver improved outcomes and greater optionality to patients in need,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “We see opportunities in HER2-positive MBC and hormone-resistant estrogen receptor positive MBC, where escape from hormone therapy is often via HER2/3 signaling. We also look forward to continuing to evaluate MCLA-128 in other tumor types, including endometrial, ovarian, gastric and NSCLC cancers in this ongoing study.”
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zal wel Trump sentiment zijn dat we zo sterk dalen in 2 dagen met toch een prima persbericht....
KeepTHeFaith
0
quote:

fly like an eagle schreef op 19 mei 2017 om 09:47:


zal wel Trump sentiment zijn dat we zo sterk dalen in 2 dagen met toch een prima persbericht....

Ben er uit gegaan op 21,20. Nu maar weer even afwachten. Misschien had ik vandaag al terug moeten happen
heb toch besloten nog even te wachten.
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Heb wel bijgekocht; zie geen reden met goede resultaten en een Incyte die 25 heeft betaald.
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