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Merus Announces Financial Results for the Second Quarter 2024 and Provides Business Update

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Merus N.V. (NASDAQ: MRUS) announced financial results for Q2 2024 and provided a business update. Key highlights include:

  • Petosemtamab showed a 67% response rate in combination with pembrolizumab in 1L HNSCC
  • First patients dosed in phase 3 trial for petosemtamab monotherapy in 2/3L HNSCC
  • Successful public offering raising $460M gross proceeds
  • Cash runway extended into 2028
  • FDA accepted BLA for zenocutuzumab in NRG1+ NSCLC and PDAC for priority review

As of June 30, 2024, Merus had $846.4 million in cash and equivalents. Q2 2024 saw collaboration revenue decrease by $3.2M, while R&D expenses increased by $20.8M and G&A expenses rose by $6.5M compared to Q2 2023.

Merus N.V. (NASDAQ: MRUS) ha annunciato i risultati finanziari per il secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:

  • Petosemtamab ha mostrato un tasso di risposta del 67% in combinazione con pembrolizumab nel 1° trattamento HNSCC
  • Primi pazienti trattati nel trial di fase 3 per la monoterapia con petosemtamab nel 2°/3° trattamento HNSCC
  • Offerta pubblica riuscita che ha raccolto 460 milioni di dollari di proventi lordi
  • Estensione del cash runway fino al 2028
  • FDA ha accettato la BLA per zenocutuzumab in NSCLC NRG1+ e PDAC per revisione prioritaria

Alla data del 30 giugno 2024, Merus disponeva di 846,4 milioni di dollari in contanti e equivalenti. Nel secondo trimestre del 2024, i ricavi da collaborazione sono diminuiti di 3,2 milioni di dollari, mentre le spese per R&S sono aumentate di 20,8 milioni di dollari e le spese generali e amministrative sono aumentate di 6,5 milioni di dollari rispetto al secondo trimestre del 2023.

Merus N.V. (NASDAQ: MRUS) anunció resultados financieros para el segundo trimestre de 2024 y proporcionó una actualización comercial. Los aspectos destacados incluyen:

  • Petosemtamab mostró una tasa de respuesta del 67% en combinación con pembrolizumab en 1L HNSCC
  • Primeros pacientes tratados en el ensayo de fase 3 para la monoterapia con petosemtamab en 2/3L HNSCC
  • Exitosa oferta pública que recaudó 460 millones de dólares en ingresos brutos
  • Extensión del cash runway hasta 2028
  • La FDA aceptó la BLA para zenocutuzumab en NRG1+ NSCLC y PDAC para revisión prioritaria

Al 30 de junio de 2024, Merus tenía 846.4 millones de dólares en efectivo y equivalentes. En el segundo trimestre de 2024, los ingresos por colaboración disminuyeron en 3.2 millones de dólares, mientras que los gastos de I+D aumentaron en 20.8 millones de dólares y los gastos generales y administrativos aumentaron en 6.5 millones de dólares en comparación con el segundo trimestre de 2023.

Merus N.V. (NASDAQ: MRUS)는 2024년 2분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:

  • 페토세믹타맙은 1차 HNSCC에서 펨브롤리주맙과 함께 67%의 반응률을 보였습니다.
  • 2/3차 HNSCC에서 페토세믹타맙 단독 요법에 대한 3상 시험에서 첫 환자가 투여되었습니다.
  • 460백만 달러의 총 수익을 올린 성공적인 공모
  • 2028년까지 현금 지출 연장
  • FDA는 NRG1+ NSCLC 및 PDAC에 대한 제노쿠투주맙의 BLA를 우선 심사로 수락했습니다.

2024년 6월 30일 기준으로 Merus는 8억 4,640만 달러의 현금 및 현금성 자산을 보유하고 있었습니다. 2024년 2분기 동안 협력 수익이 320만 달러 감소한 반면, 연구 및 개발비는 2,080만 달러 증가하고 일반 관리비는 650만 달러 증가했습니다. 2023년 2분기와 비교하여.

Merus N.V. (NASDAQ: MRUS) a annoncé les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour commerciale. Les points clés incluent :

  • Petosemtamab a montré un taux de réponse de 67 % en combinaison avec pembrolizumab dans le HNSCC de première ligne
  • Premiers patients traités dans le essai de phase 3 pour la monothérapie de petosemtamab dans le HNSCC de deuxième/troisième ligne
  • Offre publique réussie ayant levé 460 millions de dollars de produits bruts
  • Extension de la trésorerie jusqu'en 2028
  • FDA a accepté la BLA pour zenocutuzumab en NSCLC NRG1+ et PDAC pour une révision prioritaire

Au 30 juin 2024, Merus disposait de 846,4 millions de dollars en liquidités et équivalents. Le deuxième trimestre de 2024 a vu les revenus de collaboration diminuer de 3,2 millions de dollars, tandis que les dépenses de R&D ont augmenté de 20,8 millions de dollars et les dépenses administratives ont augmenté de 6,5 millions de dollars par rapport au deuxième trimestre 2023.

Merus N.V. (NASDAQ: MRUS) hat die Finanzwerte für das zweite Quartal 2024 bekannt gegeben und ein Unternehmensupdate bereitgestellt. Zu den wichtigsten Highlights gehören:

  • Petosemtamab zeigte eine Ansprechraten von 67% in Kombination mit Pembrolizumab bei 1L HNSCC
  • Erste Patienten wurden im Phase-3-Studie für die Monotherapie mit Petosemtamab bei 2/3L HNSCC behandelt
  • Erfolgreiche Aktienemission, die 460 Millionen Dollar brutto eingeworben hat
  • Cash-Roadmap bis 2028 verlängert
  • FDA akzeptierte BLA für Zenocutuzumab bei NRG1+ NSCLC und PDAC zur Prioritätsprüfung

Zum 30. Juni 2024 hatte Merus 846,4 Millionen Dollar an Bargeld und Äquivalenten. Im zweiten Quartal 2024 gab es einen Rückgang der Kooperationsumsätze um 3,2 Millionen Dollar, während die F&E-Ausgaben um 20,8 Millionen Dollar und die allgemeinen Verwaltungskosten um 6,5 Millionen Dollar im Vergleich zum Q2 2023 gestiegen sind.

Positive
  • Petosemtamab showed 67% response rate in combination with pembrolizumab in 1L HNSCC
  • Successful public offering raising $460M gross proceeds
  • Cash runway extended into 2028
  • FDA accepted BLA for zenocutuzumab in NRG1+ NSCLC and PDAC for priority review
  • Strong cash position of $846.4 million as of June 30, 2024
Negative
  • Collaboration revenue decreased by $3.2 million in Q2 2024 compared to Q2 2023
  • Research and development expenses increased by $20.8 million in Q2 2024 compared to Q2 2023
  • General and administrative expenses increased by $6.5 million in Q2 2024 compared to Q2 2023
  • Net loss of $50.042 million in Q2 2024, compared to $32.033 million in Q2 2023

Insights

Merus N.V.'s Q2 2024 financial results reveal a mix of progress and challenges. The company's cash position has significantly improved, with $846.4 million in cash, cash equivalents and marketable securities as of June 30, 2024, up from $411.7 million at the end of 2023. This boost is largely due to a successful public offering that raised $460 million in gross proceeds.

However, the company's operational metrics show some concerning trends:

  • Collaboration revenue decreased by $3.2 million compared to Q2 2023, primarily due to reduced reimbursement revenue and amortization of deferred revenue.
  • Research and development expenses increased by $20.8 million, driven by higher clinical services and drug manufacturing costs.
  • General and administrative expenses rose by $6.5 million, mainly due to increased personnel-related expenses and consulting fees.
  • Net loss for Q2 2024 was $50.0 million, compared to $32.0 million in Q2 2023.

Despite these challenges, Merus's extended cash runway, now projected to fund operations into 2028, provides a significant buffer for its ambitious clinical development plans. The company's focus on advancing its pipeline, particularly petosemtamab and zenocutuzumab, could potentially yield valuable results in the coming years.

Investors should closely monitor the progress of Merus's clinical trials and regulatory milestones, as these will be critical in determining the company's long-term value proposition.

Merus's clinical pipeline shows promising advancements, particularly in the field of targeted cancer therapies. The interim data for petosemtamab in combination with pembrolizumab in first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) is especially noteworthy, with a 67% response rate among 24 evaluable patients. This is a significant improvement over current standard-of-care treatments for HNSCC, which typically show response rates in the 30-35% range.

The company's progress with zenocutuzumab (Zeno) is also encouraging. The FDA's acceptance of the Biologics License Application (BLA) for priority review in NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer could potentially lead to a new targeted therapy option for these difficult-to-treat cancers.

However, it's important to note that these are still early-stage results and larger, randomized trials will be necessary to confirm the efficacy and safety of these therapies. The ongoing phase 3 trials for petosemtamab in HNSCC will be important in determining its potential as a new standard of care.

The company's diverse pipeline, including MCLA-129 and MCLA-145, demonstrates a strong commitment to developing novel immunotherapies. The preliminary data for MCLA-129 in METex14 NSCLC is particularly intriguing and warrants further investigation.

Overall, Merus's pipeline shows potential to address significant unmet needs in oncology, but investors should remain cautious as these therapies still need to prove their efficacy and safety in larger, more definitive trials.

Merus N.V.'s market position in the oncology space is strengthening, driven by its innovative pipeline of bispecific antibodies. The company's focus on hard-to-treat cancers like HNSCC, NSCLC and pancreatic cancer positions it well in a growing market segment.

The potential of petosemtamab in HNSCC is particularly noteworthy. With a 67% response rate in combination with pembrolizumab, it could potentially capture a significant share of the HNSCC market, estimated to reach $4.5 billion by 2026. The initiation of phase 3 trials for petosemtamab in both first-line and second/third-line HNSCC indicates Merus's commitment to fully exploring this opportunity.

Zenocutuzumab's priority review for NRG1+ cancers represents another significant market opportunity. While NRG1 fusions are rare, occurring in about 0.2% of NSCLC cases, the lack of targeted therapies for this population could allow Merus to establish a strong foothold in this niche market.

The company's collaborations with major pharmaceutical companies like Incyte, Eli Lilly and Gilead Sciences not only provide additional revenue streams but also validate Merus's technology platform. These partnerships could lead to future milestone payments and royalties, diversifying Merus's potential revenue sources.

However, investors should be aware of the highly competitive nature of the oncology market. Merus will need to demonstrate clear clinical benefits and differentiation to succeed in this crowded space. The company's financial position, with a runway into 2028, provides a solid foundation for executing its development plans, but careful management of resources will be important as multiple late-stage trials progress simultaneously.

– Petosemtamab in combination with pembrolizumab interim data presented at 2024 ASCO® demonstrated robust 67% response rate among 24 evaluable patients

– First patients dosed in phase 3 trial evaluating petosemtamab monotherapy in 2/3L HNSCC, phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in 2L mCRC, and phase 2 trial evaluating MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC

– Based on the Company’s current operating plan, existing cash, cash equivalents, including successful public offering raising $460M gross proceeds, and marketable securities expected to fund Merus’ operations into 2028

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the second quarter and provided a business update.

“Petosemtamab has already demonstrated potential for best in class efficacy with a favorable safety profile in both 1L and 2L+ HNSCC, major areas of unmet medical need. I’m also looking forward to evaluating petosemtamab in mCRC, another potential important opportunity,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “With the addition of Dr. Fabian Zohren as CMO and the recent successful equity financing raising $460M gross proceeds, we are well positioned for our ambitious phase 3 trial plans for petosemtamab in HNSCC and beyond.”

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors
LiGeR-HN2 phase 3 trial in 2/3L head and neck squamous cell carcinoma (HNSCC) enrolling and LiGeR-HN1 phase 3 trial in 1L HNSCC planned to initiate by year end 2024; phase 2 trial in 2L metastatic colorectal cancer (mCRC) enrolling; clinical data update on 2L+ HNSCC planned for late fourth quarter of 2024

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.

Merus provided an interim clinical update on petosemtamab with pembrolizumab in 1L HNSCC at the 2024 American Society of Clinical Oncology® (ASCO®) Annual Meeting, demonstrating a 67% response rate among 24 evaluable patients. The oral presentation was detailed in our press release, Merus’ Petosemtamab in Combination with Pembrolizumab Interim Data Demonstrates Robust Response Rate and Favorable Safety Profile in 1L r/m (recurrent/metastatic) HNSCC (May 28, 2024). Merus plans to initiate LiGeR-HN1, a phase 3 trial evaluating petosemtamab in combination with pembrolizumab in 1L HNSCC by year end 2024.

Merus provided an interim clinical update on petosemtamab monotherapy in 2L+ HNSCC at the American Association of Cancer Research® (AACR®) Annual Meeting 2023, demonstrating a 37% response rate among 43 evaluable patients. The oral presentation was detailed in our press release Merus’ Petosemtamab Interim Data Demonstrates Clinically Meaningful Activity in Previously Treated Head and Neck Squamous Cell Carcinoma (HNSCC) (April 17, 2023). Merus plans to provide updated efficacy, durability and safety data of this cohort along with clinical data from the dose optimization cohort evaluating petosemtamab monotherapy 1500 or 1100 mg dose levels in 2L+ HNSCC in late fourth quarter of 2024.

Merus announced the first patient was dosed in LiGeR-HN2, a phase 3 trial evaluating the efficacy and safety of petosemtamab in 2/3L HNSCC compared to standard of care. In this trial, patients will be randomized to petosemtamab monotherapy or investigator’s choice of single agent chemotherapy or cetuximab. This was detailed in our press release, Merus Announces First Patient Dosed in LiGeR-HN2, a Phase 3 Trial Evaluating Petosemtamab in 2/3L r/m HNSCC - Merus (July 24, 2024).

The FDA has granted Breakthrough Therapy Designation (BTD) 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 receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) antibody. This designation was detailed in our press release, Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA (May 13, 2024).

Merus believes a randomized registration trial in HNSCC with an overall response rate endpoint could potentially support accelerated approval and the overall survival results from the same study could potentially verify its clinical benefit to support regular approval.

Merus announced the first patient was dosed in the phase 2 open-label trial evaluating the safety and preliminary antitumor activity of petosemtamab with FOLFIRI in 2L mCRC. Trial design was detailed in our press release Merus Announces First Patient Dosed in Phase 2 Trial of Petosemtamab in 2L CRC (July 8, 2024).

Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics®): NRG1 fusion-positive (NRG1+) lung, pancreatic and other solid tumors
Zeno BLA for treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC) accepted for priority review by the FDA

The FDA has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with NRG1+ NSCLC and PDAC cancer. This acceptance was detailed in our press release Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC (May 6, 2024).

Merus believes that obtaining a commercialization partnership agreement is an important step in bringing Zeno to patients with NRG1+ cancer, if approved.

MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
Investigation of MCLA-129 is ongoing in METex14 NSCLC; phase 2 trial in combination with chemotherapy in 2L+ EGFR mutant (EGFRm) NSCLC enrolling

At 2024 ASCO® Merus presented efficacy and safety data of MCLA-129, in NSCLC with c-MET exon 14 skipping mutations (METex14). This poster presentation was detailed in our press release Merus’ MCLA-129 Demonstrates Promising Single-Agent Efficiency in METex14 NSCLC in Poster Presentation at the 2024 ASCO® Annual Meeting (June 3, 2024).

The first patients were dosed in the phase 2 trial evaluating MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC, with a cohort receiving MCLA-129 and paclitaxel and carboplatin, and another cohort receiving MCLA-129 and docetaxel. We also remain interested in partnering MCLA-129 to sufficiently resource the development of MCLA-129 and the potential benefit it may have for patients.

MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129 and potentially commercialize exclusively in China, while Merus retains global rights outside of China.

MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors

Investigation continues of the phase 1 trial of MCLA-145 in combination with pembrolizumab

Interim clinical data on MCLA-145 monotherapy and in combination with pembrolizumab in patients with advanced/metastatic solid tumors were presented at 2024 ASCO®. The oral presentation was detailed in our press release Merus Presents Interim Data on MCLA-145 Monotherapy and in Combination with Pembrolizumab at the 2024 ASCO® Annual Meeting (June 2, 2024).

Company News
Merus announced the appointment of Fabian Zohren M.D., Ph.D. as Chief Medical Officer (CMO). This management addition is detailed in our press release Merus Appoints Fabian Zohren M.D., Ph.D., as Chief Medical Officer (July 1, 2024).

Collaborations

Incyte Corporation
Since 2017, Merus has been working with Incyte Corporation (Incyte) under a global collaboration and license agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform. For each program under the collaboration, Merus receives reimbursement for research activities and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved. During the second quarter of 2024, Merus received the milestone payment of $1 million for the candidate nomination accomplished in first quarter of 2024.

Eli Lilly and Company
In January 2021, Merus and Eli Lilly and Company (Lilly), announced a research collaboration and exclusive license agreement to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies utilizing Merus’ Biclonics® platform and proprietary CD3 panel along with the scientific and rational drug design expertise of Lilly. The collaboration is progressing well with three programs ongoing at various stages of preclinical development.

Gilead Sciences
In March 2024, Merus and Gilead Sciences announced a collaboration to discover novel antibody based trispecific T-cell engagers using Merus’ patented Triclonics® platform. Under the terms of the agreement, Merus will lead early-stage research activities for two programs, with an option to pursue a third. Gilead will have the right to exclusively license programs developed under the collaboration after the completion of select research activities. If Gilead exercises its option to license any such program from the collaboration, Gilead will be responsible for additional research, development and commercialization activities for such program. Merus received an equity investment by Gilead of $25 million in Merus common shares and an upfront payment of $56 million.

Corporate Activities
Completed public offering raising $460M gross proceeds
This equity raise is detailed in a press release: Merus Announces Pricing of Upsized Public Offering of Common Shares (May 29, 2024).

Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2028

As of June 30, 2024, Merus had $846.4 million cash, cash equivalents and marketable securities. Based on the Company’s current operating plan, the existing cash, cash equivalents and marketable securities are expected to fund Merus’ operations into 2028.

Second Quarter 2024 Financial Results
We ended the second quarter with cash, cash equivalents and marketable securities of $846.4 million compared to $411.7 million at December 31, 2023.

Collaboration revenue for the three months ended June 30, 2024 decreased by $3.2 million as compared to the three months ended June 30, 2023, primarily as a result of decreases in reimbursement revenue of $1.5 million and amortization of deferred revenue of $1.7 million.

Research and development expense for the three months ended June 30, 2024 increased by $20.8 million as compared to the three months ended June 30, 2023, primarily as a result of increases in external clinical services and drug manufacturing expenses, including costs to fulfill our obligations under our collaboration agreements, related to our programs of $16.2 million, consulting expenses of $2.2 million, facilities and depreciation expenses of $1.2 million, personnel related expenses including share-based compensation of $1.0 million, consumables expenses of $0.1 million, and travel expenses of $0.1 million.

General and administrative expense for the three months ended June 30, 2024 increased by $6.5 million as compared to the three months ended June 30, 2023, primarily as a result of increases in personnel related expenses including share-based compensation of $3.7 million, consulting expenses of $3.6 million, intellectual property and license expenses of $0.5 million, and legal expenses of $0.4 million, partially offset by decreases in facilities and depreciation expense of $1.2 million, travel expenses of $0.3 million, and finance and human resources expenses of $0.2 million.

Collaboration revenue for the six months ended June 30, 2024 decreased by $8.8 million as compared to the six months ended June 30, 2023, primarily as a result of a decrease in reimbursement revenue of $2.2 million, decrease in milestone revenue of $1.5 million and decrease in amortization of deferred revenue of $5.1 million.

Research and development expense for the six months ended June 30, 2024 increased by $24.5 million as compared to the six months ended June 30, 2023, primarily as a result of increases in external clinical services and drug manufacturing expenses, including costs to fulfill our obligations under our collaboration agreements, related to our programs of $19.4 million, consulting expenses of $3.7 million, facilities and depreciation expenses of $2.3 million, pre-launch inventory of $0.2 million, and travel expenses of $0.2 million, partially offset by decreases in personnel related expenses including share-based compensation of $1.2 million and consumables expenses of $0.1 million

General and administrative expense for the six months ended June 30, 2024 increased by $7.3 million as compared to the six months ended June 30, 2023, primarily as a result of increases in personnel related expenses including share-based compensation of $4.5 million, consulting expenses of $3.2 million, legal expenses of $1.0 million, and intellectual property and license expenses of $0.8 million, partially offset by decreases in facilities and depreciation expense of $1.7 million, travel expenses of $0.3 million, and finance and human resources expenses of $0.2 million

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.

MERUS N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(Amounts in thousands, except share and per share data)
 
      
 June 30, 
2024
  December 31, 
2023
 
ASSETS     
Current assets:     
Cash and cash equivalents$629,475  $204,246 
Marketable securities 157,948   150,130 
Accounts receivable 1,842   2,429 
Prepaid expenses and other current assets 17,288   12,009 
Total current assets 806,553   368,814 
Marketable securities 58,961   57,312 
Property and equipment, net 12,090   12,135 
Operating lease right-of-use assets 10,291   11,362 
Intangible assets, net 1,658   1,800 
Deferred tax assets 543   1,199 
Other assets 2,132   2,872 
Total assets$892,228  $455,494 
LIABILITIES AND SHAREHOLDERS’ EQUITY     
Current liabilities:     
Accounts payable$4,395  $4,602 
Accrued expenses and other liabilities 40,826   38,482 
Income taxes payable 1,605   1,646 
Current portion of lease obligation 1,688   1,674 
Current portion of deferred revenue 32,350   22,685 
Total current liabilities 80,864   69,089 
Lease obligation 9,332   10,488 
Deferred revenue, net of current portion 55,260   19,574 
Total liabilities 145,456   99,151 
Commitments and contingencies - Note 6     
Shareholders’ equity:     
Common shares, €0.09 par value; 105,000,000 shares authorized at June 30, 2024 and December 31, 2023; 67,852,920 and 57,825,879 shares issued and outstanding as at June 30, 2024 and December 31, 2023, respectively 6,863   5,883 
Additional paid-in capital 1,616,367   1,126,054 
Accumulated other comprehensive income (38,899)  (22,533)
Accumulated deficit (837,559)  (753,061)
Total shareholders’ equity 746,772   356,343 
Total liabilities and shareholders’ equity$892,228  $455,494 
        


MERUS N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(Amounts in thousands, except share and per share data)
 
 Three Months Ended
June 30,
  Six Months Ended
June 30,
 
 2024  2023  2024  2023 
Collaboration revenue$7,332  $10,476  $15,221  $23,975 
Total revenue 7,332   10,476   15,221   23,975 
Operating expenses:           
Research and development 49,119   28,298   87,703   63,163 
General and administrative 22,587   16,063   38,701   31,449 
Total operating expenses 71,706   44,361   126,404   94,612 
Operating loss (64,374)  (33,885)  (111,183)  (70,637)
Other income, net:           
Interest income, net 7,130   2,795   12,047   4,790 
Foreign exchange gains (loss) 9,519   551   18,053   (4,890)
Total other income (loss), net 16,649   3,346   30,100   (100)
            
Net loss before income taxes (47,725)  (30,539)  (81,083)  (70,737)
Income tax expense 2,317   1,494   3,415   1,037 
Net loss$(50,042) $(32,033) $(84,498) $(71,774)
Other comprehensive loss:           
Currency translation adjustment (8,978)  (505)  (16,366)  3,737 
Comprehensive loss$(59,020) $(32,538) $(100,864) $(68,037)
Net loss per share attributable to common stockholders:
               
Basic and diluted$(0.81) $(0.66) $(1.41) $(1.52)
Weighted-average common shares outstanding:
               
Basic and diluted 61,851,260   48,321,708   59,968,338   47,328,259 
                

About Merus N.V.

Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website, and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding the content and timing of clinical trials, data readouts and clinical, regulatory, strategy and development updates for our product candidates; our ability to successfully advance Zeno through the regulatory, BLA review and potential commercialization processes; our planned initiation of LiGeR-HN1 by year-end, our planned update by late 4Q 2024 on the HNSCC 2L+ dose cohort and patients previously reported at AACR2023; the potential of petosetmamab for best in class efficacy with a favorable safety profile in both 1L and 2L+ HNSCC; the potential opportunity of petosemtamab being investigated in 2L mCRC in combination with FOLFIRI; our belief that we are well positioned for our ambitious phase 3 trial plans for petosemtamab in HNSCC and beyond; the potential future benefit if any for the receipt of BTD 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 receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) antibody; our belief that a randomized registration trial in HNSCC with an overall response rate endpoint could potentially support accelerated approval and the overall survival results from the same study could potentially verify its clinical benefit to support regular approval; our belief that obtaining a commercialization partnership agreement is an important step in bringing Zeno to patients with NRG1+ cancer, if approved; statements regarding the sufficiency of our cash, cash equivalents and marketable securities, and expectation that it will fund the Company into 2028; the continued investigation of MCLA-145 in combination with pembrolizumab; the advancement of the phase 1/2 trial for MCLA-129 in the dose expansion phase, in monotherapy in Met ex14 NSCLC, and MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC; the benefits of the collaborations between Incyte and Merus, Lilly and Merus, Gilead and Merus, and the potential of those collaboration for future value generation, including whether and when Merus will receive any future payment under the collaborations, including milestones or royalties, and the amounts of such payments; whether any programs under the collaboration will be successful; and our collaboration and license agreement with Betta, which permits Betta to develop MCLA-129 and potentially commercialize exclusively in China, while Merus retains full ex-China rights, including any future clinical development by Betta of MCLA-129. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the volatility in the global economy, including global instability, including the ongoing conflicts in Europe and the Middle East; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2024, filed with the Securities and Exchange Commission, or SEC, on August 1, 2024, 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.

Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.


FAQ

What was Merus' cash position as of June 30, 2024?

Merus had $846.4 million in cash, cash equivalents, and marketable securities as of June 30, 2024.

What was the response rate for petosemtamab in combination with pembrolizumab in 1L HNSCC?

Petosemtamab in combination with pembrolizumab showed a 67% response rate among 24 evaluable patients in 1L HNSCC.

How much did Merus raise in their recent public offering?

Merus raised $460 million in gross proceeds from their recent public offering.

What is the expected cash runway for Merus based on current operating plans?

Based on the current operating plan, Merus' existing cash, cash equivalents, and marketable securities are expected to fund operations into 2028.

What was Merus' net loss for Q2 2024?

Merus reported a net loss of $50.042 million for Q2 2024.

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