Y mAbs Therapeutics : Company Presentation - November

YMAB

Oncology Leadership in

Pretargeted Radioimmunotherapy

Platform and Antibody-based

Therapies

November 2024

Disclaimer

This presentation contains forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. The forward-looking statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "would," "goal," "objective," "guidance," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements include, but are not limited to, statements about early clinical data, regulatory matters, clinical trial timing and plans, the achievement of clinical and commercial milestones, future financial and operating results, including 2024 financial guidance and beyond and anticipated future cash and cash equivalents, business strategies, market opportunities, financing, and other statements that are not historical facts. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward- looking statements as a result of various factors, including but not limited to: risks associated with our financial condition and need for additional capital; risks associated with the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials including if we encounter difficulties enrolling patients in our clinical trials; the risks of delays in FDA and/or EU approval of our drug candidates or failure to receive approval; the risks related to commercializing any approved new pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our ability to enter into collaboration or other arrangements with partners; risks associated with protection of our intellectual property rights; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024, in addition to other reports the Company files from time to time with the Securities and Exchange Commission. Any forward-looking statements contained in this presentation speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

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Strongly Positioned to Drive Future Value

Novel Platforms

Commercial

Anticipated 2024

Capital

in Development

Leverage

Milestones

Efficiency

Self-Assembly

DANYELZA

GD2-SADA Phase 1

Independent

DisAssembly Pretargeted

(naxitamab-gqgk)

Part A Completion

Commercial-stage

Radioimmunotherapy

Biotech Company with

("SADA PRIT")

Anti-GD2 Antibody

CD38-SADA Phase 1

Cash of $68.1 million*

Platform

Marketed for R/R High-

Study Initiation

Risk Neuroblastoma

Financial Runway

Monoclonal Antibodies

MSK Data Readout of

into 2027

FY2024 Total Net

Phase 2 Osteosarcoma

Revenue Guidance of

Trial Anticipated

Strategic Capital

$87-95 million

Deployment

* As of September 30, 2024

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Advancing Focused Pipeline with Multiple Value-Added Catalysts Ahead

Study

Therapeutic Area

Lead Programs

Preclinical

Phase 1

Phase 2/Pivotal

Approved

Trial Sponsor

Status

Relapsed/Refractory High-Risk

201

DANYELZA (naxitamab-gqgk) Confirmatory Trial

Neuroblastoma (Pediatric)

Relapsed/Refractory High-Risk

12-230

DANYELZA (naxitamab-gqgk)

Neuroblastoma (Pediatric)

Front-Line Induction in High-Risk

BCC018

Neuroblastoma (Pediatric)

Naxitamab-gqgk

15-096

Relapsed Second-Line Osteosarcoma

(Anti-GD2)

17-251

Chemoimmunotherapy for Relapsed/

Refractory High-Risk Neuroblastoma

Butterfly

Refractory Ewing's Sarcoma

Metastatic Breast Cancer

1001

GD2-SADA: Solid Tumors (SCLC,

SADA PRIT

Malignant Melanoma, Sarcoma)

(Radioimmunotherapy)

1201

CD38-SADA: Non-Hodgkin Lymphoma

Early Programs

1002

GD2-SADA: Neuroblastoma

SADA PRIT

HER2-SADA

(Radioimmunotherapy)

B7H3-SADA

U.S. FDA approved

U.S. FDA approved

Randomized trial expected 2H 2024

Expected MSK data readout in Q4 2024

Study completed

Initiated in Q4 2023

Expect FPI in 2H 2024

Expect to complete Part A in 2024

Expect FPI in Q4 2024

Expected IND filing in 2025

Expected IND filing in 2025

Expected IND filing in 2025

Clinicaltrials.gov: BCC trial NCT05489887, MSK trial NCT02502786, OSU trial NCT06026657

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Novel SADA Pretargeted

Radioimmunotherapy

Platform

Current Radiopharma Challenges Negatively Impact Patient Care

Infrastructure and

Physician

Administration

Continuing Drug

Participation

Sites

Shortages

Manufacturing

Simpler, more user-friendly solutions greatly needed for physicians and patients

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Potential Improved Capabilities of Novel SADA PRIT 2-Step Approach

Traditional Radioimmunotherapy

Limited dose-to-tumor due to off-target radiation

Prone to drug shortages / supply issues with single-isotope only capabilities

Limited administration sites with licensed nuclear medicine radiologists

High investment needed for specific infrastructure and manufacturing

* Pending successful development and approval.

Novel SADA PRIT Platform

Potential Capabilities

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Self-Assembly DisAssembly (SADA) Technology: High Affinity for Tumor Targets and Rapid Clearance from Blood Stream

SADA domains uniquely selected to allow proteins to change size based on concentration

Self-Assembled Tetramer

DisAssembled Monomer

~200 kDa

< 70kDa

Strong Tumor Binding

Rapid Clearance

Adapted from Santich et al. Clin Canc Res 2020

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GD2-SADA Achieves High Tumor Uptake with Minimal Exposure to All Other Tissues

Blood Exposure

(Radioactive Payload)

Concentration (Radioactive Payload)

Tumor

1. IgG Bispecific

Time

2. DOTA

Tumor Uptake

(Radioactive Payload)

1. SADA Bispecific

2. DOTA

Time

Adapted from Santich et al. Clin Canc Res 2021

These early results are not complete and are not necessarily indicative of the full results or ultimate success of the trials or SADA development program.

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GD2-SADA Phase 1 Clinical Trial (Study 1001): Dosing Patients in Part A

Theranostic approach using a 30 mCi 177Lu-DOTA imaging dose before exposing to therapeutic dose

Inclusion Criteria

Inclusion Amendment

*Currently in Part A

DESIGN

OUTCOME

Part A*

N ≈ 15 - 18

GD2-SADA protein

dose-escalation from 0.3

mg/kg to 10 mg/kg

+

Therapeutic 177Lu-DOTA

dose of 100-200 mCi

(7.4 GBq)

Determine optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA

Part B

N ≈ 9 - 12

177Lu-DOTA therapeutic

dose escalation from 400 mCi (14.8 GBq) to 750 mCi (27.8 GBq)

Patients to receive up to

2 cycles

Determine maximum tolerable activity of 177Lu-DOTA

Part C

5 cycles

Doses determined in

Part A and B administered

Patients to receive maximum of 5 cycles

Assess safety and AEs following repeat dosing; determine recommended Phase 2 dose (RP2D)

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Disclaimer

Y-mAbs Therapeutics Inc. published this content on November 11, 2024, and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on November 11, 2024 at 20:45:02.607.