Duyuru • Jan 09
Merus N.V. Files Form 15 Merus N.V. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Shares, €0.09 nominal value per share under the Securities Exchange Act of 1934, as amended. Duyuru • Dec 31
Merus N.V.(NasdaqGM:MRUS) dropped from NASDAQ Composite Index Merus B.V. has been dropped from the Nasdaq Composite Index. Duyuru • Dec 30
Merus to Delist All Common Shares from Nasdaq On December 29, 2025, in connection with the effectiveness of the Back-End Transactions (as defined in the Offer to Purchase), Merus N.V. (i) notified the Nasdaq Stock Market LLC (“Nasdaq”) of the effectiveness of the Back-End Transactions and (ii) requested that Nasdaq (x) halt trading of the Common Shares effective as of the evening of December 29, 2025 and (y) file with the SEC a Notification of Removal from Listing and/or Registration under Section 12(b) of the Exchange Act on Form 25 to delist all Common Shares from Nasdaq and deregister such Common Shares under Section 12(b) of the Exchange Act. In addition, after the Form 25 becomes effective, Purchaser intends to cause the Company to file with the SEC a Certification and Notice of Termination of Registration on Form 15 and take steps to cause the suspension of all of the Company’s reporting obligations to the SEC with respect to the Common Shares. The Common Shares ceased to trade on Nasdaq prior to the opening of trading on December 30, 2025. Duyuru • Dec 13
Merus N.V.(NasdaqGM:MRUS) dropped from NASDAQ Biotechnology Index Merus N.V. has been removed from NASDAQ Biotechnology Index. Duyuru • Dec 12
Genmab A/S (CPSE:GMAB) completed the acquisition of Merus N.V. (NasdaqGM:MRUS) in a tender offer transaction. Genmab A/S (CPSE:GMAB) entered into a transaction agreement to acquire Merus N.V. (NasdaqGM:MRUS) for $7.3 billion on September 29, 2025. A cash consideration valued at $97 per share will be paid by Genmab. The transaction is not subject to a financing condition and the consideration is expected to be funded through a combination of cash on hand and approximately $5.5 billion of non-convertible debt financing. Genmab has obtained a funding commitment from Morgan Stanley Senior Funding, Inc. for this amount.
The closing of the tender offer is subject to the satisfaction of customary closing conditions for similar transactions, including a minimum acceptance condition of at least 80% of Merus’ common shares (which threshold may be reduced to 75% unilaterally by Genmab if all other closing conditions are satisfied), approval by Merus’ shareholders of resolutions relating to Merus’ postclosing governance and the back end transactions at Merus’ extraordinary shareholders meeting to be held for that purpose, and completion of the relevant works councils consultation processes. The transaction has been unanimously approved by the Boards of Directors of both companies. A wholly owned subsidiary of Genmab will commence a tender offer for 100% of Merus’ common shares, which is anticipated to close by early in the first quarter of 2026. Following the closing of the transaction, Genmab will have four proprietary programs expected to drive multiple new drug launches by 2027. Based on Genmab’s experience in late stage development and excellence in commercial execution, Genmab anticipates the potential for the initial launch of petosemtamab in 2027, subject to clinical results and regulatory approvals. Genmab also intends to broaden and accelerate petosemtamab’s development with potential expansion into earlier lines of therapy. Following its initial anticipated approval, Genmab believes that petosemtamab will be accretive to EBITDA with at least one-billion-dollar annual sales potential by 2029, with multi-billion-dollar annual revenue potential thereafter. Tender offer commenced on October 21 and is expected to close on December 11, 2025. As of October 28, 2025, each of Purchaser and Merus filed Premerger Notification and Report Forms under the HSR Act with the FTC and the Antitrust Division in connection with Purchaser’s proposed acquisition of Common Shares pursuant to the Offer. As a result, the required fifteen (15) calendar-day waiting period under the HSR Act with respect to the Offer will expire on November 12, 2025.
Morgan Stanley & Co. International plc acted as financial advisor for Genmab A/S. PJT Partners Inc. acted as financial advisor for Genmab A/S. Allen Overy Shearman Sterling LLP acted as legal advisor for Genmab A/S. Kromann Reumert acted as legal advisor for Genmab A/S. Jefferies LLC acted as financial advisor for Merus N.V. NautaDutilh N.V. acted as legal advisor for Merus N.V. Latham & Watkins B.V. acted as legal advisor for Merus N.V.
Genmab A/S (CPSE:GMAB) completed the acquisition of Merus N.V. (NasdaqGM:MRUS) in a tender offer transaction on December 12, 2025. The depositary for the Offer has advised Genmab and Purchaser that, as of the Expiration Time, a total of 71,463,077 of Merus’ issued and outstanding common shares, constituting 94.2% of its issued and outstanding common shares, had been validly tendered pursuant to the Offer. Duyuru • May 29
Merus, N.V. Provides Updates on Clinical Development Merus, N.V. announced interim clinical data as of a February 27, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab. 45 patients were treated The efficacy evaluable population consisted of 43 patients who were treated (with one or more doses) as of the data cutoff date and either 1 post-baseline tumor assessment, or discontinued early due to disease progression or death. Median follow up of 14.3 months for the 45 patients: Confirmed overall response rate: 63% (27/43, 95% CI: 49-75), including 6 complete responses, 21 partial responses by Response Evaluation Criteria in Solid Tumors v1. per investigator assessment, including: 4 of 8 patients with HPV associated cancer responded; responses observed across PD-L1 levels (CPS 1-19: 47% [8/17; CPS > 20: 73% [19/26); Median progression-free survival was 9 months (95% CI: 5.2-12.9); Median duration of response and median overall survival (OS") were not reached 79% overall survival rate at 12-months (30/43 censored); At the time of data cutoff, 14 patients, each of whom are responders, remained on treatment; In 45 patients the combination was generally well tolerated and no significant overlapping toxicities with pembrolizUMab were observed; Treatment-emergent adverse events ("TEAEs") were reported in 45 pts; G 3 TEAEs occurred in 27 (60%) patients, including 20 (44%) patients who experienced treatment-related TEAEs; Infusion-related reactions (composite term) were reported in 38% of patients (all Gs) and 7% (G3), no G4 or 5, mainly occurred during the first infusion and were resolved. The Company expects to potentially share top line interim readout results of one or both phase 3 trials in 2026. Duyuru • May 23
Merus N.V. Announces Interim Data Demonstrates Robust Efficacy and Durability in 1L Pembrolizumab Merus N.V. announced interim clinical data as of a February 27, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab. These data will be presented by Dr. Carla M. L. van Herpen M.D. Ph.D., Radboud University Medical Center, Nijmegen, Netherlands at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2 at 9 a.m. - 12:00 p.m. CT. Duyuru • Apr 15
Merus N.V., Annual General Meeting, May 21, 2025 Merus N.V., Annual General Meeting, May 21, 2025. Location: at the offices of nautadutilh n.v., beethovenstraat 400, 1082 pr, amsterdam, Netherlands Duyuru • Dec 05
Merus N.V. Announces That the United States Food and Drug Administration Approves Bizengri (Zizengri) for Treatment Indicated for Adults with Pancreatic Adenocarcinoma or Non Small Cell Lung Cancer Merus N.V. announced that the United States Food and Drug Administration has approved BIZENGRI® (zenocutuzumab-zbco) for treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy. These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BIZENGRI® has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction. The approval of BIZENGRI® is based on data from the eNRGy trial, a multicenter, open-label clinical trial that enrolled patients with NRG1+ pancreatic adenocarcinoma or NRG1+ NSCLC that is advanced unresectable or metastatic and had disease progression on or after prior systemic therapy. In patients with NRG1+ pancreatic adenocarcinoma (n=30), BIZENGRI® demonstrated an ORR of 40% (95% confidence interval (CI), 23%-59%). DOR in NRG1+ pancreatic adenocarcinoma ranged from 3.7 months to 16.6 months. In the same trial, patients with NRG1+ NSCLC (n=64) who were treated with BIZENGRI® demonstrated an ORR of 33% (95% CI, 22%-46%). The median DOR in NRG1+ NSCLC was 7.4 months (95% CI, 4.0-16.6). Response rates were measured using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR). In the pooled safety population (N=175), the most common (=10%) adverse reactions were diarrhea, musculoskeletal pain, fatigue, nausea, IRR, dyspnea, rash, constipation, vomiting, abdominal pain, and edema. The most common Grade 3 or 4 laboratory abnormalities (=2%) were increased gamma-glutamyltransferase, decreased hemoglobin, decreased sodium, decreased platelets, increased aspartate aminotransferase, increased alanine aminotransferase, increased alkaline phosphatase, decreased magnesium, decreased phosphate, increased activated partial thromboplastin time, and increased bilirubin. Reported Earnings • Nov 01
Third quarter 2024 earnings released: US$1.46 loss per share (vs US$0.43 loss in 3Q 2023) Third quarter 2024 results: US$1.46 loss per share (further deteriorated from US$0.43 loss in 3Q 2023). Revenue: US$11.8m (up 6.7% from 3Q 2023). Net loss: US$99.9m (loss widened 334% from 3Q 2023). Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 25% per year but the company’s share price has increased by 20% per year, which means it is well ahead of earnings. Duyuru • Oct 01
Merus N.V. Announces First Patient Dosed in Liger-Hn1, A Phase 3 Trial Evaluating Petosemtamab in Combination with Pembrolizumab in 1L R/M HNSCC Merus N.V. announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab as first line (1L) therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), referred to as the LiGeR-HN1 trial. Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab. Reported Earnings • Aug 04
Second quarter 2024 earnings released: US$0.81 loss per share (vs US$0.66 loss in 2Q 2023) Second quarter 2024 results: US$0.81 loss per share (further deteriorated from US$0.66 loss in 2Q 2023). Revenue: US$7.33m (down 30% from 2Q 2023). Net loss: US$50.0m (loss widened 56% from 2Q 2023). Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 18% per year but the company’s share price has increased by 44% per year, which means it is well ahead of earnings. Duyuru • Jul 08
Merus N.V. Announces First Patient Dosed in Phase 2 Trial of Petosemtamab in 2L CRC Merus N.V. announced that the first patient has been dosed in the Company’s phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in second line (2L) metastatic colorectal cancer (mCRC). Petosemtamab is a Biclonics® targeting EGFR and LGR5. The phase 2, open-label trial will evaluate the safety and preliminary antitumor of petosemtamab and a regimen of chemotherapy (FOLFIRI or FOLFOX) in 2L mCRC. The study will enroll approximately 40 patients not previously treated with EGFR inhibitors and whose tumors do not harbor a KRAS mutation. The level of tumor EGFR expression will be measured, but the study will not employ a selection criterion for high EGFR expression. Petosemtamab, or MCLA-158, is a Biclonics® low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity. Duyuru • Jul 02
Merus N.V. Announces Chief Medical Officer Changes Merus N.V. announced the appointment of Fabian Zohren M.D., PhD as Chief Medical Officer (CMO) effective July 1, 2024. Andrew Joe, M.D. will step down from the CMO role and continue to serve as a Consultant for the next three months. In addition, effective July 1, Hui Liu, Ph.D., EVP, Chief Business Officer Head of Merus U.S. is leaving Merus. The Company has initiated a search to find a replacement to head the business development function. Dr. Fabian Zohren is a proven late-stage clinical development expert, joining Merus from ImmunoGen where he was SVP and Chief Medical Officer from November 2023 through its acquisition by AbbVie in May 2024. Prior to ImmunoGen, Dr. Zohren worked at Pfizer from 2017 until 2023 where he most recently served as Global Clinical Development Leader for prostate cancer and DNA repair, a role which included Xtandi (enzalutamide) and Talzenna (talazoparib) with oversight of two clinical programs encompassing >8000 treated patients and 8 global phase 3 registrational studies in prostate and breast cancer. Earlier in his career at Pfizer, he was the Senior Medical Director and Global Clinical Leader for prostate cancer and gynecological malignancies. He joined Pfizer from Millennium Pharmaceuticals/Takeda where he was the Senior Medical Director and Early Clinical Development Leader for their Cell Signaling Franchise since 2012. Dr. Zohren received his Medical Degree and Ph.D. from the University of Dusseldorf and was a research scholar at Baylor College of Medicine in the Center for Cell and Gene Therapy. Duyuru • Jun 05
Merus N.V. Presents Interim Data on MCLA-145 Monotherapy and in Combination with Pembrolizumab At the 2024 ASCO® Annual Meeting Merus N.V. announced updated interim clinical data on MCLA-145 monotherapy and in combination with pembrolizumab were presented at the 2024 American Society of Clinical Oncology®? (ASCO®) Annual Meeting taking place in Chicago May 31, 2024 to June 4, 2024. MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors: Interim data included in the presentation describe data from patients (pts) with advanced/metastatic solid tumors who received MCLA-145 Q2W in 28 day cycles or every three weeks (Q3W) in 21 day cycles. Pts treated with the combination of MCLA-145 and pembrolizumab had cancers that either relapsed after PD-(L)1 therapies or were immunotherapy (IO) naïve. Rapid oral presentation title: Phase I study of MCLA-145, a bispecific antibody targeting CD137 and PD-L1, in solid tumors, as monotherapy or in combination with pembrolizumab Observations in the presentation include: As of a January 3, 2024 data cutoff date, 72 pts with multiple cancer types were treated; 25% of pts had non-small cell lung cancer (NSCLC); All patients were heavily pre-treated with a median of 3 prior therapies; prior IO in 49% of the monotherapy pts and 100% of the combination pts; In monotherapy, 52 pts with a variety of tumor types and treated at different dose levels were evaluable for response; 5 partial responses (PRs) were observed at different dose levels in glioblastoma (ongoing as of the cutoff date for >3 years), sarcoma (pretreated with pazopanib and gemcitabine/docetaxel), cervical, anal, and gastric cancer by Response Evaluation Criteria in Solid Tumors v1.1. per investigator assessment; 2 of 6 pts PRs (33%) were observed for pts treated at the recommended dose for expansion (RDE), 40 mg Q3W; 3 of 6 PRs (50%) were observed for pts with evaluable baseline tumor CD8 T-cell density of = 250 cells/mm2 responded; In combination with pembrolizumab, 19 pts with a variety of tumor types and treated at different dose levels were evaluable for response; 1 PR in Merkel cell carcinoma was observed at 25 mg Q3W; 1 complete response was observed in PD-L1+ NSCLC at the RDE 40 mg Q3W; 3 pts were continuing combination therapy at cutoff date; MCLA-145 monotherapy or in combination with pembrolizumab had a well-tolerated and manageable safety profile at the RDE, 40mg Q3W; Shifting from Q2W to Q3W resulted in a 50% reduction of Grade (G) =3 treatment-emergent adverse events in both monotherapy and combination therapy; Liver toxicity, a common CD137 related adverse event, was controlled with no G4 events observed at Q3W. Duyuru • May 31
Merus N.V. has completed a Follow-on Equity Offering in the amount of $400.15 million. Merus N.V. has completed a Follow-on Equity Offering in the amount of $400.15 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 7,550,000
Price\Range: $53
Discount Per Security: $3.18 Duyuru • May 29
Merus N.V. has filed a Follow-on Equity Offering in the amount of $300 million. Merus N.V. has filed a Follow-on Equity Offering in the amount of $300 million.
Security Name: Common Shares
Security Type: Common Stock Duyuru • May 15
Merus N.V. Announces Petosemtamab Grants Breakthrough Therapy Designation by the U.S. FDA Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for petosemtamab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following treatment with platinum based chemotherapy and an anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) antibody. This designation follows receipt of Fast Track Designation for petosemtamab for the treatment of patients with recurrent or metastatic HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-programmed cell death protein 1 (anti-PD-1) antibody announced in August 2023. BTD is supported by data from the ongoing phase 1/2 open-label, multicenter trial evaluating petosemtamab monotherapy in patients with advanced solid tumors, including previously treated (recurrent or metastatic) HNSCC (NCT03526835). Merus plans to provide updated efficacy, durability and safety data from this cohort in the second half of 2024. BTD is intended to expedite the development and review of a medicine to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints over available therapies. BTD allows for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review, and eligibility for rolling review and priority review. With this BTD, Merus plans to engage in these discussions with the FDA in an expedited manner as move toward goal of a potential Biologics License Application (BLA) submission. Reported Earnings • May 09
First quarter 2024 earnings released: US$0.59 loss per share (vs US$0.86 loss in 1Q 2023) First quarter 2024 results: US$0.59 loss per share (improved from US$0.86 loss in 1Q 2023). Revenue: US$7.89m (down 42% from 1Q 2023). Net loss: US$34.5m (loss narrowed 13% from 1Q 2023). Revenue is forecast to grow 48% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has increased by 35% per year, which means it is well ahead of earnings. Duyuru • May 09
Merus N.V. Appoints Jason Haddock as Non-Executive Director Merus N.V. appointed Jason Haddock as non-executive director. Duyuru • Apr 11
Merus N.V., Annual General Meeting, May 07, 2024 Merus N.V., Annual General Meeting, May 07, 2024, at 15:00 Central European Standard Time. Location: NautaDutilh N.V., Beethovenstraat 400, 1082 PR Amsterdam Netherlands Agenda: To consider discussion of the Company’s Dutch statutory annual report over the financial year 2023; to consider adoption of the Company’s Dutch statutory annual accounts over the financial year 2023; to consider explanation of the dividend and reservation policy; to consider appointment of the KPMG Accountants N.V. as the Company’s external auditor for the financial year 2024 for purposes of Dutch law; to consider release of each member of the Company’s board of directors from liability for the exercise of their duties during the financial year 2023; to consider re-appointment of Mark Iwicki as non-executive director; to consider re-appointment of Paolo Pucci as non-executive director; to consider appointment of Jason Haddock as non-executive director; and to consider other matters. Duyuru • Mar 07
Merus N.V. announced that it has received $25.000035 million in funding from Gilead Sciences, Inc. Merus N.V. announced that it has entered into the Collaboration Agreement, pursuant to the Subscription Agreement with new investor, Gilead Sciences, Inc. that the company has issued 452,527 common shares at a price per share of $55.2454 for aggregate gross proceeds of $25,000,035 on March 5, 2024. Gilead Sciences, Inc. agreed to transfer, sell, or otherwise dispose of the Shares for a period of time following the purchase of the Shares, subject to certain customary exceptions. The Shares were issued in reliance upon an exemption from registration provided for under Section 4(a)(2) of the Securities Act of 1933, as amended. Reported Earnings • Mar 01
Full year 2023 earnings released: US$3.00 loss per share (vs US$2.92 loss in FY 2022) Full year 2023 results: US$3.00 loss per share (further deteriorated from US$2.92 loss in FY 2022). Revenue: US$43.9m (up 5.7% from FY 2022). Net loss: US$154.9m (loss widened 18% from FY 2022). Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has increased by 36% per year, which means it is well ahead of earnings. Duyuru • Feb 29
Merus N.V. has filed a Follow-on Equity Offering in the amount of $300 million. Merus N.V. has filed a Follow-on Equity Offering in the amount of $300 million.
Security Name: Common Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Reported Earnings • Nov 04
Third quarter 2023 earnings released: US$0.43 loss per share (vs US$0.53 loss in 3Q 2022) Third quarter 2023 results: US$0.43 loss per share (improved from US$0.53 loss in 3Q 2022). Revenue: US$11.0m (up 68% from 3Q 2022). Net loss: US$23.0m (loss narrowed 6.5% from 3Q 2022). Revenue is forecast to grow 44% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has increased by 25% per year, which means it is well ahead of earnings. Duyuru • Oct 24
Merus N.V. Announces Interim Data Continues to Demonstrate Robust and Durable Responses in NRG1+ Cancer Merus N.V. announced interim clinical data, as of a July 31, 2023 data cutoff date, from the phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) cancer presented by Principal Investigator, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center at the European Society for Medical Oncology (ESMO) Congress 2023. The reported data are from the phase 1/2 eNRGy trial and EAP which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. Reported Earnings • Aug 08
Second quarter 2023 earnings released: US$0.66 loss per share (vs US$0.13 loss in 2Q 2022) Second quarter 2023 results: US$0.66 loss per share (further deteriorated from US$0.13 loss in 2Q 2022). Revenue: US$10.5m (down 17% from 2Q 2022). Net loss: US$32.0m (loss widened 461% from 2Q 2022). Revenue is forecast to grow 41% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has increased by 28% per year, which means it is well ahead of earnings. Duyuru • Jul 06
U.S. Food and Drug Administration Grants Second Breakthrough Therapy Designation for zenocutuzumab (Zeno) of Merus N.V Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) non-small cell lung cancer (NSCLC), following progression with prior systemic therapy. This designation for Zeno follows BTD for the treatment of patients with NRG1+ pancreatic cancer, following progression with prior systemic therapy or in patients who have no satisfactory alternative treatment options recently announced on June 30, 2023, Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancer) that have progressed on standard of care therapy announced in January 2021 and Orphan Drug Designation for the treatment of patients with pancreatic cancer announced in July 2020. BTD is supported by data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP) which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer (Phase 1/2: NCT02912949, EAP: NCT04100694). Data from the eNRGy trial and EAP were featured as oral presentations during the 2021 and 2022 American Society of Clinical Oncology Annual Meetings (Abstract #3003, #105 respectively). As of June 1, 2023, more than 175 patients with NRG1+ cancer have been treated with Zeno monotherapy. BTD is intended to expedite the development and review of a medicine to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints over available therapies. BTD allows for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review, and eligibility for rolling review and priority review. With this BTD, Merus plans to engage in these discussions with the FDA in an expedited manner, and then provide a further update on the path and timeline to a potential Biologics License Application (BLA) submission. Merus believes that obtaining a commercialization partnership agreement will be an essential step in bringing Zeno to patients with NRG1+ cancer, if approved. Merus plans to provide a clinical update on Zeno in NRG1+ cancer at a major medical conference in 2023. Further, Merus is evaluating Zeno in combination with androgen deprivation therapy (enzalutamide or abiraterone) in castration resistant prostate cancer (CRPC), irrespective of NRG1+ status. Merus plans to provide initial clinical data on Zeno in CRPC in the second half of 2023. Merus is also evaluating Zeno in combination with afatinib in patients with NRG1+ NSCLC. Duyuru • Jun 16
Merus Appoints Greg Perry as Chief Financial Officer Merus N.V. announced the appointment of Greg Perry as the Company’s Chief Financial Officer (CFO). Additionally, Greg has been designated as the Company’s principal financial officer, succeeding Bill Lundberg, M.D., in such role. In connection with his appointment as the Company’s Chief Financial Officer, on June 14, 2023, Greg resigned from the Company’s Board of Directors Greg Perry has served as a non-executive director of the Merus Board of Directors since May 2016 and Vice Chair of the Board since August 2018. Greg remains a non-executive director of the Board of Directors of Kala Pharmaceuticals, a role he has held since March 2018. Prior to joining Merus, Greg was the CFO of Finch Therapeutics from May 2018 through April 2022. Previously Greg held various senior financial leadership roles at several biotech companies including Novelion Therapeutics, Eleven Biotherapeutics, ImmunoGen, Domantis, and Transkaryotic Therapies. Greg transitioned to the biotech industry after beginning his career at General Electric, where he served in increasingly senior financial roles over fourteen years. He earned a B.A. in Economics and Political Science from Amherst College. Reported Earnings • May 07
First quarter 2023 earnings released: US$0.86 loss per share (vs US$0.43 loss in 1Q 2022) First quarter 2023 results: US$0.86 loss per share (further deteriorated from US$0.43 loss in 1Q 2022). Revenue: US$13.5m (up 16% from 1Q 2022). Net loss: US$39.7m (loss widened 110% from 1Q 2022). Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 6% per year whereas the company’s share price has increased by 5% per year. Reported Earnings • Mar 02
Full year 2022 earnings released: US$2.92 loss per share (vs US$1.73 loss in FY 2021) Full year 2022 results: US$2.92 loss per share (further deteriorated from US$1.73 loss in FY 2021). Revenue: US$41.6m (down 15% from FY 2021). Net loss: US$131.2m (loss widened 96% from FY 2021). Revenue is forecast to grow 38% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has only increased by 3% per year, which means it is significantly lagging earnings growth. Duyuru • Jan 07
Merus N.V. Announces Executive Changes On January 4, 2023, the Board of Directors of Merus N.V. (the Company) appointed Peter B. Silverman, the Company’s Executive Vice President, General Counsel and Head of Utrecht, to serve as the Company’s Executive Vice President, Chief Operating Officer and General Counsel. Additionally, Mr. Silverman has been designated as the Company’s principal operating officer, succeeding Sven (Bill) Ante Lundberg, M.D., in such role. Peter B. Silverman, age 45, has served the Company since 2014, first as outside counsel, as Head of Utrecht from April 2020 to January 1, 2023, as General Counsel since February 2018 and Chief Intellectual Property Officer and Head of US Legal from February 2017. His responsibilities include management of the Company’s legal and intellectual property, company operations, information technology, facilities and human resource matters, and management and operations of the headquarters in Utrecht. Prior to joining the Company, Mr. Silverman was a Partner at Kirkland & Ellis LLP, where he represented numerous life sciences companies concerning an array of legal matters and technologies. Previously, Mr. Silverman was an associate at Kaye Scholer LLP (now Arnold & Porter Kaye Scholer LLP), and prior to that Mr. Silverman also served as judicial law clerk to U.S. District Court Judge Anne E. Thompson of the District of New Jersey. He holds a J.D. from Fordham University School of Law, graduating magna cum laude and Order of the Coif. He is admitted to practice law in New York. Mr. Silverman also holds a B.A. in biology from the University of Rochester. Breakeven Date Change • Dec 12 The 9 analysts covering Merus previously expected the company to break even in . New consensus forecast suggests the company will make a profit of US$0 in . Earnings growth of 76% is required to achieve expected profit on schedule.
Reported Earnings • Nov 05
Third quarter 2022 earnings released: US$0.53 loss per share (vs US$0.39 loss in 3Q 2021) Third quarter 2022 results: US$0.53 loss per share (further deteriorated from US$0.39 loss in 3Q 2021). Revenue: US$6.58m (down 52% from 3Q 2021). Net loss: US$24.6m (loss widened 66% from 3Q 2021). Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 11% per year whereas the company’s share price has increased by 16% per year. Duyuru • Oct 27
Merus N.V. Presents First in Human Data on MCLA-129 at the 34th EORTC/NCI/AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics Merus N.V. announced the publication of interim data as of an August 15, 2022 data cutoff, from the ongoing phase 1/2 trial of the bispecific antibody MCLA-129, on the 34th EORTC/NCI/AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA Symposium) website. MCLA-129 is a fully human ADCC enhanced IgG1 Biclonics® bispecific antibody that binds to EGFR and c-MET and is being investigated in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. This phase 1/2 study has completed the dose escalation phase and is on-going in the dose expansion phase. As of the May 8, 2022 cutoff date, 20 patients were treated with MCLA-129 across doses of 100, 300, 600, 1000, and 1500 mg every two weeks. These patients were followed for safety and efficacy through a data cutoff of August 15, 2022, with 18 evaluable for efficacy, with two discontinuing before the second infusion (1 patient due to investigator decision, clinical progression; and 1 patient passing away due to an unrelated AE). As of the August 15, 2022 cutoff date: Median age of patients was 65.5 years (range 43-79); Tumor types enrolled included: 14 patients with EGFR mutant (mt) NSCLC (8 Del19, 4 L858R, 1 exon 20 insertion [EGFRex20], 1 other); 2 patients with c-MET exon 14 mt (MetEx14) NSCLC; 1 patient with c-MET amplified gastric adenocarcinoma; 1 patient with esophageal squamous cell cancer; 2 patients with head and neck squamous cell carcinoma (HNSCC); Antitumor activity observed by investigator review, include: 2 confirmed partial responses observed; 4 additional patients had >20% tumor shrinkage; Time on treatment: Median duration of exposure was 12.6 weeks (range: 3-43 weeks); Six of the 20 patients remained on-going as of the data cutoff date; MCLA-129 was observed to be well tolerated based on 20 patients who received one or more doses of MCLA-129 across all dose levels tested: No dose limiting toxicities (DLTs) were reported; Most frequent AEs were infusion-related reactions (IRR); 90% of patients experienced IRR AEs of any grade, one patient (5%) experienced a grade 3, no grade 4 or 5 AEs were observed; The majority of AEs occurred during the first infusion; No treatment-related grade 4 or 5 AEs reported; No patients discontinued MCLA-129 treatment due to drug-related toxicity; No interstitial lung disease reported; Based on pharmacokinetic and pharmacodynamic data, and the safety profile an initial recommend phase 2 dose was selected at 1500 mg every two weeks. As October 2022, 33 patients have been enrolled in the dose escalation and dose expansion phases of the trial. The additional 13 patients enrolled did not yet have an opportunity to be evaluated for response as of the August 15, 2022 data cutoff. The MCLA-129 trial is ongoing in the dose expansion phase, treating patients with MCLA-129 monotherapy in MetEx14 NSCLC, EGFRex20 NSCLC, HNSCC, as well as in combination with a third generation EGFR tyrosine kinase inhibitor (TKI) in treatment naïve EGFRmt NSCLC and in patients with EGFRmt NSCLC that have progressed on Tagrisso (osimertinib). Reported Earnings • Aug 10
Second quarter 2022 earnings released: US$0.13 loss per share (vs US$0.71 loss in 2Q 2021) Second quarter 2022 results: US$0.13 loss per share (up from US$0.71 loss in 2Q 2021). Revenue: US$12.7m (up 2.5% from 2Q 2021). Net loss: US$5.71m (loss narrowed 79% from 2Q 2021). Over the next year, revenue is forecast to grow 7.4%, compared to a 15% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has increased by 24% per year, which means it is tracking significantly ahead of earnings growth. Duyuru • Jun 06
Merus N.V. Presents Clinical Data on Zenocutuzumab in NRG1-Fusion Cancer at the 2022 American Society of Clinical Oncology Annual Meeting Merus N.V. announced interim efficacy data as of an April 12, 2022 data cutoff date, from the phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody Zeno in patients with NRG1+ cancer presented virtually by Lead Author, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC) at the 2022 ASCO Annual meeting. Key findings of the presentation include: As of April 12, 2022, 110 patients were treated with Zeno; Efficacy was assessed in 79 evaluable patients with measurable disease having the opportunity for 6 months or more follow-up and who met the criteria for the primary analysis population; Median age was 59 years (range of 22-84); 59% were female; Median number of prior lines of systemic therapy was 2, (range of 0-8); Qualifying NRG1 fusions included 26 distinct fusion partners; ORR per RECIST criteria as assessed by investigator was 34% (95% Cl; 24%-46%) across multiple tumor types: PDAC ORR 42% (8/19) and NSCLC ORR 35% (16/46); Tumor shrinkage was observed in 70% of patients; Median time to response was 1.8 months, and median duration of exposure was 6.3 months; Median duration of response was 9.1 months, and 20/83 patients were continuing treatment as of the cutoff date; Strong safety profile with a low incidence of Grade 3 or higher treatment-related adverse events, including low rates of severe gastrointestinal and dermatologic toxicity, without clinically significant cardiotoxicity. Reported Earnings • May 11
First quarter 2022 earnings released: US$0.43 loss per share (vs US$0.28 loss in 1Q 2021) First quarter 2022 results: US$0.43 loss per share (down from US$0.28 loss in 1Q 2021). Revenue: US$11.7m (up 40% from 1Q 2021). Net loss: US$18.9m (loss widened 86% from 1Q 2021). Over the next year, revenue is expected to shrink by 15% compared to a 37% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has increased by 5% per year, which means it is well ahead of earnings. Duyuru • May 02
Merus N.V., Annual General Meeting, May 31, 2022 Merus N.V., Annual General Meeting, May 31, 2022, at 15:00 Central European Standard Time. Agenda: To consider discussion of the Dutch statutory annual report over the financial year 2021; to consider adoption of the Dutch statutory annual accounts over the financial year 2021; to consider explanation of the dividend and reservation policy; to consider release of each member of our board of directors from liability for the exercise of their duties; to consider Granting authorization to acquire shares (or depository receipts for such shares) in the Company’s capital. Duyuru • Mar 10
Merus N.V. Announces Publication of Abstract on MCLA-129 At the American Association for Cancer Research 2022 Annual Meeting Merus N.V. announced the publication of the abstract highlighting the mechanism of action of MCLA-129 on the American Association for Cancer Research (AACR) website. MCLA-129, is a Biclonics®, which binds to EGFR and c-MET; EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition. The poster will be on display at the AACR Annual Meeting 2022 in New Orleans, Louisiana on Sunday, April 10, 2022 and available on the e-poster website beginning on April 8 at 1:00 p.m. ET. MCLA-129 is currently enrolling patients in a phase 1/2, open-label clinical trial consisting of dose escalation followed by a planned dose expansion. Primary objectives of phase 1 are to determine the maximum tolerated dose and/or the recommended phase 2 dose, and the objectives of phase 2 are to evaluate safety, tolerability and potential clinical activity in patients with advanced solid tumors. MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129 exclusively in China, while Merus retains global rights outside of China. In October 2021, Betta announced that the first patient was dosed in a phase 1/2 trial in China sponsored by Betta, of MCLA-129 in patients with advanced solid tumors. Merus plans to provide a clinical update in the second half of 2022. Reported Earnings • Mar 04
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat Full year 2021 results: US$1.73 loss per share (up from US$2.92 loss in FY 2020). Revenue: US$49.1m (up 64% from FY 2020). Net loss: US$66.8m (loss narrowed 22% from FY 2020). Revenue exceeded analyst estimates by 77%. Over the next year, revenue is expected to shrink by 19% compared to a 64% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 19% per year but the company’s share price has increased by 29% per year, which means it is well ahead of earnings. Duyuru • Dec 11
Merus N.V. Presents Updated Analysis of Zenocutuzumab, Trastuzumab, and Vinorelbine in Patients with HER2+ Metastatic Breast Cancer at San Antonio Breast Cancer Symposium Merus N.V. presented clinical data on zenocutuzumab (Zeno) in combination with trastuzumab and vinorelbine in patients (pts) with HER2 positive/amplified (HER2+) metastatic breast cancer (MBC) who had progressed on anti-HER2 antibody drug conjugates (ADC), at the San Antonio Breast Cancer Symposium in San Antonio, Texas. The reported data are from the completed phase 2 study, designed to explore the efficacy of a triplet combination of Zeno plus trastuzumab and vinorelbine in MBC patients (NCT03321981). Preliminary results for patients treated with the triplet regimen were presented at the American Society of Clinical Oncology 2020 Annual Meeting. The combination was observed to be well-tolerated in the run-in cohort and the cohort was expanded. The primary endpoint of the study was clinical benefit rate (CBR) at 24 weeks of 45%. Updated results from the cohort expansion are presented here: at the efficacy data cut-off, March 31, 2021, 39 patients, with a median age of 57 and with a median number of five prior therapies, had received the Zeno-based triplet combination, 4 of whom were ongoing. All patients had completed at least 6 months of treatment or discontinued; 37 patients with locally confirmed HER2 overexpression (IHC 3+ or IHC 2+/FISH-positive) were evaluable for antitumor activity; the clinical benefit rate (CBR: complete response + partial response + stable disease =24 weeks) per investigator assessment was 49% (18/37 patients; 90% CI 34 - 63); confirmed responses (per investigator) were reported in 10 patients, including 2 patients with complete response (CR); median duration of response was 4.2 months (90% CI 2.8 - 12.4), including 2 patients with CR lasting 4.2 and 7.2+ months, and 8 patients with partial responses (PR) lasting from 2.6 to 12.4 months; median progression-free survival was 5.5 months (90% CI 4.1 - 5.6); 7 patients (19%) were censored. Estimated overall survival rates at 12 and 24 months were 73% and 61%, respectively; and the combination was observed to be well tolerated, with AEs primarily related to chemotherapy. As previously reported, with completion of this phase 2 trial, the company does not have plans to advance into a phase 3 clinical trial in metastatic breast cancer in the absence of a partner. The company continues to focus on the eNRGy trial to potentially support a BLA submission seeking a tumor agnostic indication for Zeno in patients with previously treated NRG1+ cancers. Reported Earnings • Nov 04
Third quarter 2021 earnings released: US$0.39 loss per share (vs US$0.79 loss in 3Q 2020) The company reported a solid third quarter result with reduced losses, improved revenues and improved control over expenses. Third quarter 2021 results: Revenue: US$13.7m (up 60% from 3Q 2020). Net loss: US$14.9m (loss narrowed 36% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 23% per year but the company’s share price has increased by 33% per year, which means it is well ahead of earnings. Reported Earnings • Aug 09
Second quarter 2021 earnings released: US$0.71 loss per share (vs US$0.62 loss in 2Q 2020) The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: US$12.4m (up 104% from 2Q 2020). Net loss: US$27.4m (loss widened 52% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 22% per year but the company’s share price has only fallen by 1% per year, which means it has not declined as severely as earnings. Breakeven Date Change • Jun 23
Forecast to breakeven in 2024 The analyst covering Merus expects the company to break even for the first time. New forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 42% is required to achieve expected profit on schedule. Breakeven Date Change • Jun 08
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 44% is required to achieve expected profit on schedule. Breakeven Date Change • Jun 06
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 36% is required to achieve expected profit on schedule. Duyuru • Jun 05
Merus N.V. Presents Clinical Data on Zenocutuzumab in Nrg1-Fusion (Nrg1+) Cancers At the American Society of Clinical Oncology (Asco) 2021 Annual Meeting Merus N.V. announced interim efficacy data, as of an April 13, 2021 cutoff date, from the phase 1/2 eNRGy trial and Early Access Program (EAP) of bispecific antibody zenocutuzumab (Zeno) in patients with NRG1+ cancers, presented virtually by Lead Author, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC) at the 2021 ASCO Annual Meeting. The reported data are from the ongoing phase 1/2 eNRGy trial and EAP which are investigating 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 (NSCLC); and NRG1+ other solid tumors. Key findings in the presentation include: Enrollment of 61 patients with NRG1+ pancreatic, NSCLC, and other cancers; 47 patients were evaluable for primary analysis, with a median age of 56 (range 22-84), previously treated with a median of 2 lines of prior therapy; 45 patients were evaluable for response by local review with measurable disease and the opportunity for = 1 post-baseline tumor assessment (two patients with non-measurable disease are included in the primary analysis of 47 patients, but not included in the 45 evaluable for response); First prospective clinical validation of NRG1 fusions as actionable oncogenic drivers that may be amenable to targeted therapy with Zeno. Breakeven Date Change • Jun 03
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 50% is required to achieve expected profit on schedule. Breakeven Date Change • Jun 01
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 44% is required to achieve expected profit on schedule. Breakeven Date Change • May 29
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 43% is required to achieve expected profit on schedule. Breakeven Date Change • May 26
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 43% is required to achieve expected profit on schedule. Breakeven Date Change • May 23
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 37% is required to achieve expected profit on schedule. Duyuru • May 21
Merus N.V. Announces Publication of Abstract on Zenocutuzumab in NRG1-fusion (NRG1+) Cancers at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting Merus N.V. announced the publication of the abstract highlighting interim data, as of a January 12, 2021 cutoff, from the phase 1/2 eNRGY trial and Early Access Program (EAP) of bispecific antibody zenocutuzumab (Zeno) in patients with NRG1+ cancers, on the ASCO website. An oral presentation containing an updated interim analysis with a data cutoff date of April 13, 2021 will be presented virtually by Lead Author, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC) at the 2021 ASCO Annual Meeting. Key findings in the abstract include: As of January 12, 2021, 51 patients were treated with Zeno, of whom 33 were evaluable for response. Tumor regression was observed in 25 out of 33 patients, with confirmed partial responses in 9 of 33 (27% ORR), including 4 of 10 patients (40% ORR) with pancreatic cancer. Zeno continues to be well tolerated with the majority of adverse events of mild or moderate (Grade 1 or 2) severity, regardless of causality. 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. Breakeven Date Change • May 20
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 50% is required to achieve expected profit on schedule. Breakeven Date Change • May 18
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 50% is required to achieve expected profit on schedule. Breakeven Date Change • May 17
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 50% is required to achieve expected profit on schedule. Breakeven Date Change • May 14
Forecast to breakeven in 2024 The 7 analysts covering Merus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.66m in 2024. Average annual earnings growth of 42% is required to achieve expected profit on schedule. Duyuru • May 14
Merus Announces Collaborations in Israel, Italy and Spain to Increase Screening and Identification of Cancer Patients with NRG1 Fusion Tumors and to Raise Awareness of the Phase 1/2 eNRGy Clinical Trial Merus N.V. announced new collaborations in Israel, Italy and Spain to expand molecular screening opportunities for patients with cancers that may have neuregulin 1 (NRG1) fusions and to raise awareness of the Merus eNRGy clinical trial of its bispecific antibody zenocutuzumab. In the collaborations, Merus plans to support molecular screenings for eligible patients with pancreatic adenocarcinoma in Israel and Italy, and with non-small cell lung cancer (NSCLC) in Spain, aimed to identify the presence of NRG1 fusions. Each collaborating organization in turn has agreed as follows: Progenetics Ltd. plans to perform a nationwide campaign in Israel to raise awareness of the molecular screening offered by Merus for eligible pancreatic adenocarcinoma patients and availability of the eNRGy trial for eligible patients. Progenetics is a leading Israeli company in oncology testing, currently distributing diagnostic tests for nine American companies in the field of onco-diagnostics; Italian Association for the Study of Pancreas (AISP) plans to inform their nationwide network of oncologists, pancreatic cancer patients and patient associations in Italy of the molecular screening offered by Merus for eligible pancreatic adenocarcinoma patients and availability of the eNRGy trial for eligible patients; Universidad de Navarra plans to provide Merus-funded molecular screening to eligible patients with NSCLC, through the Clínica Universidad de Navarra network in Spain, which may identify NRG1 fusions, and plans to inform patients with NRG1-fusion-positive cancer of their potential eligibility for the eNRGy trial. The Clínica Universidad de Navarra, based in Pamplona and Madrid, is a leading research hospital in Spain. A recognized institution for both its teaching and research work, and its trajectory in the diagnosis and treatment of highly complex pathologies, the Clínica Universidad de Navarra is characterized by the diagnostic speed achieved through multidisciplinary work and the acquisition of the latest technology to offer care in 46 different medical and surgical specialties; Merus has implemented a global approach designed to increase access to molecular screenings for cancer patients and to potentially enhance enrollment in the eNRGy trial by working with private industry, country-specific testing organizations, cooperative groups and disease-specific cancer organizations. Increasing access to molecular screenings may help oncologists and their patients, whose cancers may not be screened routinely for gene mutations, make informed decisions on what treatment and clinical trial options may be available; With the addition of these collaborations announced today, Merus is now working with more than ten different industry and academic collaborators across Asia, North America and Europe aimed to enhance testing for NRG1 fusions and to raise awareness of the eNRGy trial; 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 zenocutuzumab (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. 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: Zenocutuzumab (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 with NRG1 gene fusions (NRG1+). 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. Reported Earnings • May 08
First quarter 2021 earnings released: US$0.28 loss per share (vs US$0.57 loss in 1Q 2020) The company reported a solid first quarter result with reduced losses, improved revenues and improved control over expenses. First quarter 2021 results: Revenue: US$8.35m (up 33% from 1Q 2020). Net loss: US$10.2m (loss narrowed 39% from 1Q 2020). Over the last 3 years on average, earnings per share has fallen by 10% per year but the company’s share price has increased by 6% per year, which means it is well ahead of earnings. Duyuru • May 04
Merus Announces First Patient Treated in Phase 1/2 Clinical Trial of MCLA-129 in Advanced Lung Cancer and Other Solid Tumors Merus N.V. announced that the first patient has been treated in its phase 1/2 dose escalation and expansion trial evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics®, which binds to EGFR and c-MET. EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition. The phase 1/2, open-label clinical trial of MCLA-129 consists of dose escalation followed by dose expansion. Primary objectives of phase 1 are to determine the maximum tolerated dose and/or the recommended phase 2 dose, and the objectives of phase 2 are to evaluate safety, tolerability and potential clinical activity of the recommended phase 2 dose in patients with advanced solid tumors. MCLA-129 is the subject of a collaboration agreement between Merus and Betta Pharmaceuticals Co. Ltd. (Betta). In January 2019, Merus and Betta announced this strategic collaboration to develop MCLA-129, where Merus granted Betta an exclusive license to develop and potentially commercialize MCLA-129 in China, with Merus retaining all rights outside of China. In January 2021, Betta announced that the Chinese National Medical Product Administration accepted its Investigational New Drug application of MCLA-129 injection. Reported Earnings • Mar 18
Full year 2020 earnings released: US$2.92 loss per share (vs US$2.28 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: US$29.9m (down 3.8% from FY 2019). Net loss: US$85.5m (loss widened 55% from FY 2019). Products in clinical trials Phase I: 6 Duyuru • Jan 22
Loxo Oncology at Lilly and Merus N.V. Announce Collaboration to Discover Novel T-Cell Re-Directing Bispecific Antibodies Loxo Oncology at Lilly and Merus N.V. 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 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. Duyuru • Jan 13
Merus N.V. Announces Collaborations with Nationwide Medical Organizations in the Netherlands and Japan to Enhance Screening and Identification of Cancer Patients with NRG1 Fusion Tumors and to Raise Awareness of the eNRGy Clinical Trial Merus N.V. 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 CenterRotterdam (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. Duyuru • Jan 12
Merus N.V. Announces Presentation of Phase 1 Clinical Data for MCLA-158 at the American Society of Clinical Oncology (ASCO) 2021 Gastrointestinal Cancers Symposium Merus N.V. announced that clinical data from its Phase 1 dose escalation study of MCLA-158 will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2021 Gastrointestinal Cancers Symposium (ASCO GI) annual meeting being held virtually from January 15-17, 2021. Phase 1 dose escalation study of MCLA-158, a first in class bispecific antibody targeting EGFR and LGR5, in metastatic colorectal cancer (CRC). MCLA-158 is an ADCC enhanced human IgG1 Biclonics® designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). Is New 90 Day High Low • Jan 12
New 90-day high: €16.00 The company is up 44% from its price of €11.10 on 14 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €14.44 per share. Duyuru • Jan 08
U.S. Food and Drug Administration Grants Merus N.V. Fast Track Designation of Zenocutuzumab for the Treatment of Patients with Neuregulin 1 Fusion Cancers Merus N.V. announced that the U.S. Food and Drug Administration has granted Fast Track Designation to Zenocutuzumab (Zeno) for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard of care therapy. Fast Track is a designation granted by the FDA that is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. NRG1 gene fusions are a group of rare genomic alterations emerging as potential actionable drivers of tumorigenesis and growth across many types of solid tumors, including lung, breast, pancreatic, ovarian, and colorectal cancers. Merus is currently enrolling patients into the Phase 1/2 eNRGy trial evaluating Zeno monotherapy in patients with NRG1+ cancers, in three cohorts: non-small cell lung cancer; pancreatic cancer; and other solid tumors. Is New 90 Day High Low • Dec 10
New 90-day high: €14.70 The company is up 60% from its price of €9.20 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Nov 13
New 90-day high: €11.40 The company is up 6.0% from its price of €10.80 on 14 August 2020. The German market is up 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 17% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.