Full Press Release Details
On Cancer September 2020
Disclaimer This presentation (including any oral commentary that
accompanies this marketable drugs; potential adverse public reaction to the use of cancer presentation) contains forward-looking statements within the meaning of immunotherapies; potential delays in enrollment of patients, which could the Private
Securities Litigation Reform Act of 1995. All statements affect the receipt of necessary regulatory approvals; failure to obtain contained in this presentation that do not relate to matters of historical marketing approval internationally; failure
to compete successfully against fact should be considered forward-looking statements, including without other drug companies; potential competition from other drug companies limitation statements regarding the impact our Biclonics platform can
if we fail to obtain orphan drug designation or maintain orphan drug have on cancer, our product candidates' potential to treat certain types of exclusivity for our products; our reliance on third parties to conduct our tumors, the timing of
regulatory filings and the timing and anticipated clinical trials and the potential for those third parties to not perform data read outs or results from our clinical trials and our collaborations. satisfactorily; our reliance on third parties to
manufacture our product These forward-looking statements are based on management's current candidates, which may delay, prevent or impair our development and expectations. These statements are neither promises nor guarantees, but commercialization
efforts; protection of our proprietary technology; our involve known and unknown risks, uncertainties and other important patents being found invalid or unenforceable; potential lawsuits for factors that may cause our actual results, performance or
achievements to infringement of third-party intellectual property; our ability to attract and be materially different from any future results, performance or retain key personnel; managing our growth could result in difficulties; and achievements
expressed or implied by the forward-looking statements, we may lose our foreign private issuer status and incur significant including, but not limited to, the following: we have incurred significant expenses as a result. losses, are not currently
profitable and may never become profitable; our These and other important factors discussed under the caption "Risk need for additional funding, which may not be available and which may Factors" in our in our Quarterly Report on Form
10-Q for the quarterly require us to restrict out operations or require us to relinquish rights to period ended June 30, 2020 filed with the Securities and Exchange our technologies or bispecific antibody candidates; potential delays in Commission,
or SEC, on August 6, 2020, and our other reports filed with regulatory approval and impacts of the COVID-19 pandemic, which would the SEC, could cause actual results to differ materially from those impact our ability to commercialize our product
candidates and affect our indicated by the forward-looking statements made in this presentation. ability to generate revenue; the unproven approach to therapeutic Any such forward-looking statements represent management's estimates TM intervention
of our Biclonics , and Triclonics technology; our limited as of the date of this presentation. While we may elect to update such operating history; economic, political, regulatory and other risks involved forward-looking statements at some
point in the future, we disclaim any with international operations; the lengthy and expensive process of obligation to do so, even if subsequent events cause our views to change. clinical drug development, which has an uncertain outcome; the
unpredictable nature of our early stage development efforts for 2Disclaimer This presentation (including any oral commentary that accompanies this marketable drugs; potential adverse public reaction to the use of cancer presentation) contains
forward-looking statements within the meaning of immunotherapies; potential delays in enrollment of patients, which could the Private Securities Litigation Reform Act of 1995. All statements affect the receipt of necessary regulatory approvals;
failure to obtain contained in this presentation that do not relate to matters of historical marketing approval internationally; failure to compete successfully against fact should be considered forward-looking statements, including without other
drug companies; potential competition from other drug companies limitation statements regarding the impact our Biclonics platform can if we fail to obtain orphan drug designation or maintain orphan drug have on cancer, our product candidates'
potential to treat certain types of exclusivity for our products; our reliance on third parties to conduct our tumors, the timing of regulatory filings and the timing and anticipated clinical trials and the potential for those third parties to not
perform data read outs or results from our clinical trials and our collaborations. satisfactorily; our reliance on third parties to manufacture our product These forward-looking statements are based on management's current candidates, which may
delay, prevent or impair our development and expectations. These statements are neither promises nor guarantees, but commercialization efforts; protection of our proprietary technology; our involve known and unknown risks, uncertainties and other
important patents being found invalid or unenforceable; potential lawsuits for factors that may cause our actual results, performance or achievements to infringement of third-party intellectual property; our ability to attract and be materially
different from any future results, performance or retain key personnel; managing our growth could result in difficulties; and achievements expressed or implied by the forward-looking statements, we may lose our foreign private issuer status and
incur significant including, but not limited to, the following: we have incurred significant expenses as a result. losses, are not currently profitable and may never become profitable; our These and other important factors discussed under the
caption "Risk need for additional funding, which may not be available and which may Factors" in our in our Quarterly Report on Form 10-Q for the quarterly require us to restrict out operations or require us to relinquish rights to period
ended June 30, 2020 filed with the Securities and Exchange our technologies or bispecific antibody candidates; potential delays in Commission, or SEC, on August 6, 2020, and our other reports filed with regulatory approval and impacts of the
COVID-19 pandemic, which would the SEC, could cause actual results to differ materially from those impact our ability to commercialize our product candidates and affect our indicated by the forward-looking statements made in this presentation.
ability to generate revenue; the unproven approach to therapeutic Any such forward-looking statements represent management's estimates TM intervention of our Biclonics , and Triclonics technology; our limited as of the date of this
presentation. While we may elect to update such operating history; economic, political, regulatory and other risks involved forward-looking statements at some point in the future, we disclaim any with international operations; the lengthy and
expensive process of obligation to do so, even if subsequent events cause our views to change. clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for 2
Merus Overview Oncology-focused Company Developing Multispecific
Antibody Therapies Bispecific and trispecific cancer therapeutic candidates based on the human IgG format Established Clinical Pipeline Clinical proof-of-concept with zenocutuzumab ("Zeno") in patients with neuregulin 1 (NRG1) positive
gene fusion (NRG1+) cancers Near Term Data Readouts and Strong Cash Position into 2H 2022 Zeno NRG-1 phase 1/2 clinical data 2Q 2021 Leading Multispecific Antibody (Multiclonics ) Platforms Common light chain format permits broad high
throughput Biclonics and Triclonics discovery Strategic Collaborations to Unlock Platform Value Multiple strategic collaborations and license agreements 3Merus Overview Oncology-focused Company Developing Multispecific Antibody
Therapies Bispecific and trispecific cancer therapeutic candidates based on the human IgG format Established Clinical Pipeline Clinical proof-of-concept with zenocutuzumab ("Zeno") in patients with neuregulin 1 (NRG1) positive gene
fusion (NRG1+) cancers Near Term Data Readouts and Strong Cash Position into 2H 2022 Zeno NRG-1 phase 1/2 clinical data 2Q 2021 Leading Multispecific Antibody (Multiclonics ) Platforms Common light chain format permits broad high throughput
Biclonics and Triclonics discovery Strategic Collaborations to Unlock Platform Value Multiple strategic collaborations and license agreements 3
Merus Multiclonics Bispecific and Trispecific Cancer Therapeutic
Candidates in Human Monoclonal Antibody Formats Large-scale screening to select from up to 1,000s of candidates Potential to identify best and new biological combinations Fully human IgG format allows for: Ease of
manufacturing Low immunogenicity risk Predictable in vivo behavior Durable, consistent half life Potential for ADCC enhancement and Fc silencing Robust IP portfolio: patents covering Multiclonics
technology, including common light chain antibody generation and dimerization by charge engineering 4Merus Multiclonics Bispecific and Trispecific Cancer Therapeutic Candidates in Human Monoclonal Antibody Formats Large-scale screening
to select from up to 1,000s of candidates Potential to identify best and new biological combinations Fully human IgG format allows for: Ease of manufacturing Low immunogenicity risk Predictable in vivo
behavior Durable, consistent half life Potential for ADCC enhancement and Fc silencing Robust IP portfolio: patents covering Multiclonics technology, including common light chain antibody generation and dimerization by
charge engineering 4
Merus Clinical Pipeline BISPECIFIC PROGRAM TARGETS INDICATION(S)
PRECLINICAL PHASE 1 PHASE 1/2 STATUS Phase 1/2 trial ongoing NRG1+ Pancreatic Zenocutuzumab (Zeno) NRG1+ Lung HER3 x HER2 Clinical data and program (MCLA-128) NRG1+ Other solid tumors update planned 2Q 2021 Phase 1 Trial Ongoing MCLA-158 Lgr5 x EGFR
Solid tumors Update planned YE 2020 (ex- U.S.) MCLA-145 CD137 x PD-L1 Solid tumors Phase 1 Trial Ongoing IND Enabling (China) MCLA-129 EGFR x c-MET Solid tumors Studies Ongoing ONO-4685* Autoimmune disease Phase 1 Trial Ongoing PD-1 x CD3 .*
Autoimmune disease Undisclosed * If commercialized, Merus to receive royalties 5Merus Clinical Pipeline BISPECIFIC PROGRAM TARGETS INDICATION(S) PRECLINICAL PHASE 1 PHASE 1/2 STATUS Phase 1/2 trial ongoing NRG1+ Pancreatic Zenocutuzumab (Zeno) NRG1+
Lung HER3 x HER2 Clinical data and program (MCLA-128) NRG1+ Other solid tumors update planned 2Q 2021 Phase 1 Trial Ongoing MCLA-158 Lgr5 x EGFR Solid tumors Update planned YE 2020 (ex- U.S.) MCLA-145 CD137 x PD-L1 Solid tumors Phase 1 Trial Ongoing
IND Enabling (China) MCLA-129 EGFR x c-MET Solid tumors Studies Ongoing ONO-4685* Autoimmune disease Phase 1 Trial Ongoing PD-1 x CD3 .* Autoimmune disease Undisclosed * If commercialized, Merus to receive royalties 5
Zenocutuzumab Promising early clinical activity MCLA-128 or
"Zeno" in patients with NRG1+ cancers HER2 x HER3 bispecific HER3 NRG-1 positive gene fusions (NRG1+) are rare genetic target events occurring in lung, pancreatic and other solid tumors Unique DOCK & BLOCK
mechanism of Zeno potently inhibits NRG1+-driven tumor growth HER2 target Enhanced ADCC mediates tumor elimination by cancer immune effector cells cell eNRGy Trial enrolling and Early Access Program ongoing Clinical data and
program update expected 2Q 2021 6Zenocutuzumab Promising early clinical activity MCLA-128 or "Zeno" in patients with NRG1+ cancers HER2 x HER3 bispecific HER3 NRG-1 positive gene fusions (NRG1+) are rare genetic target events
occurring in lung, pancreatic and other solid tumors Unique DOCK & BLOCK mechanism of Zeno potently inhibits NRG1+-driven tumor growth HER2 target Enhanced ADCC mediates tumor elimination by cancer immune effector cells
cell eNRGy Trial enrolling and Early Access Program ongoing Clinical data and program update expected 2Q 2021 6
Zeno DOCK & BLOCK Mechanism of Action Uniquely Suited to
Target NRG1+ Cancers Zeno Blocks Tumor Growth in NRG1+ PDX Model Tumor Volume 3 (mm ) DOCKS BLOCKS to HER2 on tumor HER3 signaling even 1400 Control Zeno cells to efficiently in high NRG1+ tumor 1200 Zeno block HER2:HER3 environments 1000 dimer
formation + 800 Enhanced ADCC then mediates tumor 600 elimination by 400 immune killer cells 200 0 1 8 15 22 29 Study Day Zeno blocks tumor cell growth and survival driven by HER3 ligands, including neuregulin (NRG-1) or NRG-1 positive gene fusions
(NRG1+) 7 Source: Geuijen C et al. Cancer Cell (2018) https://www.cell.com/cancer-cell/fulltext/S1535-6108(18)30174-0#%20Zeno DOCK & BLOCK Mechanism of Action Uniquely Suited to Target NRG1+ Cancers Zeno Blocks Tumor Growth in NRG1+ PDX
Model Tumor Volume 3 (mm ) DOCKS BLOCKS to HER2 on tumor HER3 signaling even 1400 Control Zeno cells to efficiently in high NRG1+ tumor 1200 Zeno block HER2:HER3 environments 1000 dimer formation + 800 Enhanced ADCC then mediates tumor 600
elimination by 400 immune killer cells 200 0 1 8 15 22 29 Study Day Zeno blocks tumor cell growth and survival driven by HER3 ligands, including neuregulin (NRG-1) or NRG-1 positive gene fusions (NRG1+) 7 Source: Geuijen C et al. Cancer Cell (2018)
Zeno Safety Profile for Single Agent Use Safety Data in Over 100
Patients in Phase 1/2 Trials Safety and Tolerability in Phase 1/2 Trial OVER 100 PATIENTS EVALUATED* Zeno Dosing: 750 mg ranging from q1w-q3w Single agent well tolerated Low risk for immunogenicity Most AEs were grade 1-2
Data cut off: Jan-2019. Refer to https://merus.nl/publications/ for full data presented. Refer to ASCO poster 2018 and AACR-NCI-EORTC International Conference on 8 Molecular Targets and Cancer Therapeutics 2019
https://merus.nl/app/uploads/2019/10/AACR-NCI-EORTC_Poster-LB-B12_NRG1-MCLA-128_10252019_FINAL.pdfZeno Safety Profile for Single Agent Use Safety Data in Over 100 Patients in Phase 1/2 Trials Safety and Tolerability in Phase 1/2 Trial OVER 100
PATIENTS EVALUATED* Zeno Dosing: 750 mg ranging from q1w-q3w Single agent well tolerated Low risk for immunogenicity Most AEs were grade 1-2 Data cut off: Jan-2019. Refer to https://merus.nl/publications/ for full data
presented. Refer to ASCO poster 2018 and AACR-NCI-EORTC International Conference on 8 Molecular Targets and Cancer Therapeutics 2019 https://merus.nl/app/uploads/2019/10/AACR-NCI-EORTC_Poster-LB-B12_NRG1-MCLA-128_10252019_FINAL.pdf
Size Zeno Clinical Response in NRG1+ Cancers Patient Data Presented at
2019 AACR-NCI-EORTC International Conference Example pancreatic cancer patient: As of Oct. 2019, 7+ months MCLA-128, 750 mg IV, q2w Maximal related toxicity grade 2 300 0 -10 CA 19-9 250 -20 RECIST (%change from baseline) -30 200 -40 150 -50
-44% -60 100 -54% -70 -80 50 -90 0 -100 0 4 8 12 16 20 24 28 32 Weeks Source: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2019 9
https://merus.nl/app/uploads/2019/10/AACR-NCI-EORTC_Poster-LB-B12_NRG1-MCLA-128_10252019_FINAL.pdf/ CA19-9Size Zeno Clinical Response in NRG1+ Cancers Patient Data Presented at 2019 AACR-NCI-EORTC International Conference Example pancreatic cancer
patient: As of Oct. 2019, 7+ months MCLA-128, 750 mg IV, q2w Maximal related toxicity grade 2 300 0 -10 CA 19-9 250 -20 RECIST (%change from baseline) -30 200 -40 150 -50 -44% -60 100 -54% -70 -80 50 -90 0 -100 0 4 8 12 16 20
24 28 32 Weeks Source: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2019 9 https://merus.nl/app/uploads/2019/10/AACR-NCI-EORTC_Poster-LB-B12_NRG1-MCLA-128_10252019_FINAL.pdf/ CA19-9
Zeno Activity and Promising Durability Observed in Patients Zeno NRG1+
Clinical Activity Reported by MSKCC at 2019 AACR-NCI-EORTC International Conference PANCREATIC CANCER LUNG CANCER Tumor size reduction 41% (PR) 54% (PR) 25% (SD) PET scan nd Neg Neg Decline in tumor marker ~75% ~90% N/A Duration of treatment (mo)
>7* >7* ~ 5* Source: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2019 https://merus.nl/app/uploads/2019/10/AACR-NCI-EORTC_Poster-LB-B12_NRG1-MCLA-128_10252019_FINAL.pdf Overall Experience with Zeno in
NRG1+ Tumors as of October 2019 N PANCREATIC CANCER LUNG CANCER Evaluable 6 PR 7 mo*; SD 7 mo PR 5 mo*; SD 7 mo; PD; PD Died of progressive disease Non-evaluable 3 2 Pts not yet at first evaluation prior to first evaluation 5 patients enrolled on
the eNRGy trial; 4 patients treated under Early Access Program Source: Merus Press Release Oct 27, 2019 https://ir.merus.nl/news-releases/news-release-details/merus-bispecific-antibody-mcla-128-shows-encouraging-early *Indicates treatment was
ongoing at the time of the conference; nd, no data; N/A, not applicable 10Zeno Activity and Promising Durability Observed in Patients Zeno NRG1+ Clinical Activity Reported by MSKCC at 2019 AACR-NCI-EORTC International Conference PANCREATIC CANCER
LUNG CANCER Tumor size reduction 41% (PR) 54% (PR) 25% (SD) PET scan nd Neg Neg Decline in tumor marker ~75% ~90% N/A Duration of treatment (mo) >7* >7* ~ 5* Source: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer
Therapeutics 2019 https://merus.nl/app/uploads/2019/10/AACR-NCI-EORTC_Poster-LB-B12_NRG1-MCLA-128_10252019_FINAL.pdf Overall Experience with Zeno in NRG1+ Tumors as of October 2019 N PANCREATIC CANCER LUNG CANCER Evaluable 6 PR 7 mo*; SD 7 mo PR 5
mo*; SD 7 mo; PD; PD Died of progressive disease Non-evaluable 3 2 Pts not yet at first evaluation prior to first evaluation 5 patients enrolled on the eNRGy trial; 4 patients treated under Early Access Program Source: Merus Press Release Oct 27,
2019 https://ir.merus.nl/news-releases/news-release-details/merus-bispecific-antibody-mcla-128-shows-encouraging-early *Indicates treatment was ongoing at the time of the conference; nd, no data; N/A, not applicable 10
Zeno Clinical Programs in NRG1+ Cancers eNRGy Clinical Trial and Early
Access Program Ongoing Early Access Program Pancreatic Cancer Phase 1/2 global single arm trial For eligible patients who do not of Zeno in NRG1+ cancers enroll on the eNRGy trial Cohorts include Pancreatic, NSCLC,
Allows patients with NRG1+ cancers and other solid tumors to receive treatment with Zeno NSCLC Majority of clinical trial sites open Evaluations and patient follow up and enrolling may be similar to eNRGy protocol Ongoing
Phase 1/2 trial update May provide additional clinical data expected 2Q 2021 in support of Zeno NRG1+ program Other Solid Tumors 11Zeno Clinical Programs in NRG1+ Cancers eNRGy Clinical Trial and Early Access Program Ongoing Early Access
Program Pancreatic Cancer Phase 1/2 global single arm trial For eligible patients who do not of Zeno in NRG1+ cancers enroll on the eNRGy trial Cohorts include Pancreatic, NSCLC, Allows patients with NRG1+ cancers and
other solid tumors to receive treatment with Zeno NSCLC Majority of clinical trial sites open Evaluations and patient follow up and enrolling may be similar to eNRGy protocol Ongoing Phase 1/2 trial update May provide
additional clinical data expected 2Q 2021 in support of Zeno NRG1+ program Other Solid Tumors 11
Identifying and Recruiting NRG1+ Patients NRG1+ Cancers are Found
Across Comprehensive Effort to Identify Multiple Solid Tumor Types and Recruit NRG1+ Patients ESTIMATED TUMOR TYPE INCIDENCE (%) IDENTIFICATION COLLABORATION PLACEMENT Patient testing and Physician, trial site Patient logistics / LUNG 0.3 -
3.0 physician engagement engagement & support support for eNRGy campaigns 1-833-NRG-1234 trial or EAP www.nrg1.com PANCREAS 0.5 - 1.5 OTHER < 1.0 Early Access Program Note: Projections of NRG1+ estimated incidence based on limited
published information, including Jonna S et al. Clinical Cancer Research (2019); independent epidemiology review https://ir.merus.nl/news-releases/news-release-details/merus-announces-acceptance-six-abstracts-upcoming-medical; and Wang (2015);
Duruisseaux (2017); Trombetta (2018); McCoach (2018); 12 Karlsson (2019); Drilon (2018); Fernandez-Cuesta (2014); Seto (2018); and Scheel (2015) Identifying and Recruiting NRG1+ Patients NRG1+ Cancers are Found Across Comprehensive Effort to