Investor Presentation August 2019 1 Forward-Looking Statements - - PowerPoint PPT Presentation

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Investor Presentation August 2019 1 Forward-Looking Statements - - PowerPoint PPT Presentation

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Investor Presentation August 2019 1 Forward-Looking Statements This presentation, in addition to historical information, contains certain forward- looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such

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SLIDE 1

Investor Presentation

August 2019

1

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SLIDE 2

Forward-Looking Statements

2

This presentation, in addition to historical information, contains certain forward- looking statements made pursuant to the Private Securities Litigation Reform Act of

  • 1995. Such statements may involve significant risks and uncertainties, and actual

results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, new product development (including clinical trials outcome and regulatory requirements /actions); competitive risks to marketed products; forecasts of future operating results; availability of required financing and other sources of funds on acceptable terms, if at all; as well as those discussed in the Company's filings with the Securities and Exchange Commission.

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SLIDE 3

Strong Foundation to Deliver Breakthrough Therapies for Hard-to-Treat Cancers

3

OUR VISION

Create and deliver breakthrough therapies for hard-to-treat cancers, transforming patients’ lives

OUR MISSION

Become the leading antibody-drug conjugate (ADC) company dedicated to patients – building, developing, manufacturing and commercializing a highly differentiated portfolio of biologic therapies

Put patients at the heart

  • f all we do

Make all decisions through science Deliver results, create sustainable value Pursue the highest quality Embrace diversity, treat with respect

Patient-centric Science-based Performance-driven Quality Obsessed We Before Me

OUR WAY

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SLIDE 4

Unique ADC(1) Platform with Late-Stage Assets Targeting Multiple Underserved Indications

Notes: 1. Antibody Drug Conjugate 4

Lead product – targeting late-line triple-negative breast cancer

Re-submit BLA in 2019

Science with depth & breadth across multiple hard-to-treat solid tumor indications

9+ potential indications for sacituzumab govitecan

Compelling benefit:risk profile

Combinations for earlier treatment lines

Potential markets

Multi-billion dollar

  • pportunity

globally

Two ADCs in pipeline

For additional solid and liquid tumor indications

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SLIDE 5

T H E I M M U N O M E D I C S S T O R Y

Transforming the Treatment Paradigm for Complex Cancers

5

  • The company – at an inflection point
  • Lead product – establishing leadership in mTNBC
  • Our “pipeline in a product”
  • Next 3 major indications targeted
  • The future – 2019 and 2020 priorities and milestones
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SLIDE 6

Immunomedics Today – Transitioning to Fully Integrated, Biopharma Company

6

Well Financed

  • Cash on hand

$433M as of 6/30/2019

  • Funds strategic

priorities through 2020

Growing Market Value

  • Multi billion dollar

market cap generating significant shareholder value

  • ver the last 2

years

Strong IP Portfolio

  • Lead ADC

protected until 2033

  • 44 active U.S.

and 30 foreign patents

Building Integrated Global Biotech

  • Global strategy for

development & commercialization

  • Global supply

chain & mfg.

  • Core commercial

infrastructure

Seasoned Leadership Team

  • Experts in

manufacturing, global drug development & commercialization

  • Track record of

developing and launching blockbuster drugs

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SLIDE 7

Value-Creating Licensing Agreement with Everest Medicines for Greater China and Beyond

7

  • $65 million non-refundable

upfront payment

  • $60 million upon approval in

mTNBC in U.S.

  • Up to $180 million development

milestone payments

  • Up to $530 million sales

milestone payments

  • 14% - 20% royalty rates

Largest Single-Asset In-Licensing Deal for Regional China To-Date

  • Preeminent biopharma

company in Greater China

  • Current partners, among
  • thers, include

Strategic optionality in core established markets worldwide maintained

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SLIDE 8

Robust Global Supply-Chain In Place for Sacituzumab Govitecan – Committed to Capacity and Scale Expansion

8

  • 1. Antibody Manufacturing
  • 2. Drug-Linker

Pharma Services

  • 3. Conjugation, Fill, Finish

Morris Plains (2020 onward)

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SLIDE 9

A Powerful Differentiated ADC Platform: Three Key Advantages

9

  • ADC platform uses SN-38 as

payload of choice

  • SN-38 kills cancer cells by

damaging DNA

  • 1. Payload – Validated & Well

Tolerated

  • Hydrolyzable linker for payload

release

  • Allows for intra- and extra-cellular

(bystander effect) killing of tumor cells

  • 2. Novel Linker
  • hRS7 in sacituzumab govitecan targets Trop-2 in multiple

solid tumor indications

  • Other pipeline assets: labetuzumab govitecan targets

CEACAM5, IMMU-140 targets HLA-DR

  • 3. Antibody – Highly Tumor Specific
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SLIDE 10

Broad Pipeline of Differentiated ADC Therapies

10

Compound Indication Designation Preclinical Phase 1 Phase 2 Phase 3 Approval Sacituzumab govitecan

(IMMU-132) mTNBC (3L+) mTNBC (3L) ASCENT Urothelial (3L) TROPHY U-01 HR+/HER2‒ mBC TROPICS-02 CPI combo (mBC / mUC / mNSCLC) PARPi combo (mBC / mUC / ovarian) SEASTAR* Basket (mNSCLC / mSCLC / H&N / endometrial) TROPICS-03

IMMU-130

CRC

IMMU-140

Hematologic cancers Re-submit BLA

* In collaboration with Clovis Oncology, Inc.

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SLIDE 11

T H E I M M U N O M E D I C S S T O R Y

Transforming the Treatment Paradigm for Complex Cancers

11

  • The company – at an inflection point
  • Lead product – establishing leadership in mTNBC
  • Our “pipeline in a product”
  • Next 3 major indications targeted
  • The future – 2019 and 2020 priorities and milestones
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SLIDE 12

S A C I T U Z U M A B G O V I T E C A N F O R m T N B C – O V E R V I E W

Highly Differentiated Therapy for mTNBC

Treatment Line

  • mTNBC patients with at least 2 prior treatments in the

metastatic setting The Unmet Need

  • Low response rates, short response duration and significant

side effects with currently available therapies

  • Patients with pre-existing peripheral neuropathy or cardiac

impairment may only have supportive care options Market Size

  • U.S. ~8k patients
  • EU5, Japan ~14k patients

Status

  • Re-submit BLA in early Q4 2019

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SLIDE 13

E V I D E N C E O F E F F E C T I V E N E S S

Sacituzumab Govitecan Achieved Impressive ORR and PFS Compared to SoC in Late-Line mTNBC*

13

33

(N=108)

18 15 11

ORR

(%)

1.7 2.8 2.7 5.5

(N=108)

PFS

(months)

Sacituzumab Govitecan in ≥3rd line4 Capecitabine in 2nd line2 Eribulin in 2nd line1 Taxane, Cap, Gem or Vin in 2nd line3 Sacituzumab Govitecan in ≥3rd line4 Eribulin in 2nd line1 Taxane, Cap, Gem or Vin in 2nd line3 Capecitabine in 2nd line2

* Information is based on comparative results from independent studies Source of data: 1) Pivot X, Ann Oncol 2016; 2) Perez EA, Breast Can Res Treat 2010; 3) Brufsky A, Breast Can Res Treat. 2012; 4) Bardia A, NEJM 2019

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SLIDE 14

Adverse Event mTNBC Population (N=108) Overall Safety Population (N=420) Grade 3 (%) Grade 4 (%) Grade 3 (%) Grade 4 (%) Blood and lymphatic system

Neutropenia 26 16 25 13 Anemia 11 11

General and administration-site

Fatigue and asthenia 8 11

Gastrointestinal

Diarrhea 8 9 Nausea 6 5 Vomiting 6 4

Manageable and Predictable Safety Profile Allows for Repeated Dosing

14 Source of data: Bardia A, et al. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019; 380:741-51

Grades 3 and 4 Adverse Events Occurring in >5% of Patients

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SLIDE 15

Confirmatory ASCENT Study of Sacituzumab Govitecan Reached Target Enrollment

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT02574455 15

  • First patient dosed in November 2017 in U.S.
  • SPA protocol accepted by EU regulatory authority
  • Reached target enrollment in <20 months

Continue treatment until progression

N = 488

mTNBC

≥2 prior treatments OR 1 therapy for advanced disease who also progressed within 12 months of (neo)adjuvant therapy

Amended ASCENT Phase 3 Study (under SPA): Overview

Primary Endpoint

  • PFS

Secondary Endpoint

  • OS

Indication Endpoint

Sacituzumab govitecan 10 mg/kg IV day 1 & 8, every 21 days Traditional chemotherapy treatment of physicians’ choice

Twin Arm Study

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SLIDE 16

T H E I M M U N O M E D I C S S T O R Y

Transforming the Treatment Paradigm for Complex Cancers

16

  • The company – at an inflection point
  • Lead product – establishing leadership in mTNBC
  • Our “pipeline in a product”
  • Next 3 major indications targeted
  • The future – 2019 and 2020 priorities and milestones
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SLIDE 17

Multiple Initiatives to Drive Value for Sacituzumab Govitecan

17

Sacituzumab Govitecan

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SLIDE 18

T H E I M M U N O M E D I C S S T O R Y

Transforming the Treatment Paradigm for Complex Cancers

18

  • The company – at an inflection point
  • Lead product – establishing leadership in mTNBC
  • Our “pipeline in a product”
  • Next 3 major indications targeted
  • The future – 2019 and 2020 priorities and milestones
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SLIDE 19

Advancing Our Three Key Sacituzumab Govitecan Programs

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Indication Study Designation Treatment Line Phase of Study Study Status Pivotal Advanced Urothelial Cancer TROPHY U-01

Post platinum- based chemo- therapy and CPI

2 Initiated June 2018

✓

HR+/HER2‒ Metastatic Breast Cancer TROPICS-02

Post hormonal, CDK4/6 and 2 chemotherapies

3 Initiated April 2019

✓

Trop-2-Enriched Basket Study TROPICS-03

Refractory NSCLC, SCLC, HNSCC, and endometrial

2 Initiated July 2019

‒

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SLIDE 20

S A C I T U Z U M A B G O V I T E C A N F O R U R O T H E L I A L C A N C E R - O V E R V I E W

Metastatic Urothelial Cancer – Targeting our 2nd High Unmet

Need Indication

The Unmet Need

  • Current therapies for metastatic disease post chemotherapy

and immune checkpoint inhibitors offer low response rate, short response duration and high toxicity Market Size

  • ≥2nd line mUC – U.S. ~14k patients
  • ≥2nd line mUC – EU5, Japan ~18k patients

Status

  • May obtain accelerated approval based on results of Ph 2

TROPHY U-01 trial

20

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SLIDE 21

21

31

(N=45)

14 8.6 8.9

Docetaxel in 2nd line Phase 33 Docetaxel in 2nd line Phase 22 Vinflunine in 2nd line1 Sacituzumab Govitecan in ≥3rd line4 Docetaxel in 2nd line Phase 33 Docetaxel in 2nd line Phase 22 Vinflunine in 2nd line1 Sacituzumab Govitecan in ≥3rd line4

ORR

(%)

PFS

(months) 3.0 7.3

(N=45)

2.8 2.76

E V I D E N C E O F E F F E C T I V E N E S S

Sacituzumab Govitecan Achieved Strong ORR and PFS Compared to SoC in 2nd-Line Advanced Urothelial Cancer*

* Information is based on comparative results from independent studies Source of data: 1) Bellmunt J, JCO 2009; 2) Petrylak D, JCO 2016; 3) Petrylak D, Lancet 2017; 4) Tagawa S, ASCO-GU 2019

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SLIDE 22

Pivotal TROPHY U-01 Study of Sacituzumab Govitecan Designed to Support Accelerated Approval

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT03547973 22

  • First patient dosed in August 2018 in U.S.
  • Cohort 1 enrollment expected to be completed before YE 2019

Continue treatment until progression

mUC

Cohort 1: Post platinum- and CPI-based therapies (N= 100) OR Cohort 2: 2nd line post CPI for cisplatin-ineligible patients (N = 40) Primary Endpoint

  • ORR (BICR)

Secondary Endpoint

  • DoR, PFS & OS

Indication Endpoint

Sacituzumab govitecan 10 mg/kg IV day 1 & 8, every 21 days

Single-Arm Study

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SLIDE 23

Indication Study Designation Treatment Line Phase of Study Study Status Pivotal Advanced Urothelial Cancer TROPHY U-01

Post platinum- based chemo- therapy and CPI

2 Initiated June 2018

✓

HR+/HER2‒ Metastatic Breast Cancer TROPICS-02

Post hormonal, CDK4/6 and 2 chemotherapies

3 Initiated April 2019

✓

Trop-2-Enriched Basket Study TROPICS-03

Refractory NSCLC, SCLC, HNSCC, and endometrial

2 Initiated July 2019

‒

Advancing Our Three Key Sacituzumab Govitecan Programs

23

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SLIDE 24

S A C I T U Z U M A B G O V I T E C A N F O R H R + / H E R 2 ‒ M E T A S T A T I C B R E A S T C A N C E R – O V E R V I E W

New Therapeutic Options Needed for HR+/HER2– mBC

The Unmet Need

  • The most common form of breast cancer in U.S.
  • Initial treatments, endocrine and CDK4/6 therapy, eventually

fail and cancer relapses, requiring chemotherapy treatment

  • Prognosis for patients with visceral metastases is poor

Market Size

  • 3rd line HR+/HER2‒ mBC – U.S. ~25k patients
  • 3rd line HR+/HER2‒ mBC – EU5, Japan ~35k patients

Status

  • Potential accelerated approval submission from ORR analysis
  • n pre-specified number of patients in registrational Phase 3

TROPICS-02 study

24

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SLIDE 25

25

31

(N=54)

13 11.0

Vinorelbine in 2nd line chemo mBC1 Sacituzumab Govitecan in ≥3rd line chemo3

ORR

(%)

PFS

(months) 3 6.8

(N=54)

4.1 4.2

E V I D E N C E O F E F F E C T I V E N E S S

Sacituzumab Govitecan Achieved Impressive ORR and PFS Compared to SoC in Late-Line HR+/HER2– mBC*

* Information is based on comparative results from independent studies Source of data: 1) Jones S, JCO 1995; 2) Kaufman PA, JCO 2015; 3) Kalinsky K, SABCS 2018

11.5

Sacituzumab Govitecan in ≥3rd line chemo3 Eribulin in 3rd line chemo mBC2 Eribulin in 3rd line chemo mBC2 Capecitabine in 3rd line chemo mBC2 Capecitabine in 3rd line chemo mBC2 Vinorelbine in 2nd line chemo mBC1

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SLIDE 26

Registrational Phase 3 TROPICS-02 Study in Late-Line HR+/HER2– mBC Designed to Support Accelerated Approval

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Continue treatment until progression

N = 400

HR+/HER2‒ mBC

  • Prior hormonal and

CDK4/6 treatments

  • ≥2 prior chemotherapies

Protocol Allows ORR Analysis for Potential Accelerated Approval Submission

Primary Endpoint

  • PFS, ORR

Secondary Endpoint

  • OS, DoR, Safety, QoL

Indication Endpoint

Sacituzumab govitecan 10 mg/kg IV day 1 & 8, every 21 days Traditional chemotherapy treatment of physicians’ choice

Twin Arm Study

  • First patient dosed in June 2019 in U.S.

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCTNCT03901339

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SLIDE 27

Indication Study Designation Treatment Line Phase of Study Study Status Pivotal Advanced Urothelial Cancer TROPHY U-01

Post platinum- based chemo- therapy and CPI

2 Initiated June 2018

✓

HR+/HER2‒ Metastatic Breast Cancer TROPICS-02

Post hormonal, CDK4/6 and 2 chemotherapies

3 Initiated April 2019

✓

Trop-2-Enriched Basket Study TROPICS-03

Refractory NSCLC, SCLC, HNSCC, and endometrial

2 Initiated July 2019

‒

Advancing Our Three Key Sacituzumab Govitecan Programs

27

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SLIDE 28

S A C I T U Z U M A B G O V I T E C A N F O R m N S C L C – O V E R V I E W

Non-Small Cell Lung Cancer – Large Population with High Unmet Need

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The Unmet Need

  • NSCLC accounts for about 85% of all lung cancers
  • Following initial treatment with checkpoint inhibitors and

chemotherapy, therapeutic 2nd line options for advanced disease are limited Market Size

  • Trop-2-enriched* mNSCLC – U.S. ~20k patients
  • Trop-2-enriched* mNSCLC – EU5, Japan ~30k patients

Status

  • Trop-2 biomarker-selected study (TROPICS-03) launched

to evaluate sacituzumab govitecan in NSCLC

* Initially targeting highest 25% Trop-2 expressors with potential increase of this percentage allowed under the study protocol

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SLIDE 29

E V I D E N C E O F E F F E C T I V E N E S S

Sacituzumab Govitecan Achieved Impressive Results of ORR and PFS Compared to SoC in 2nd-Line mNSCLC*

29

17

(N=54)

12 9 9

Docetaxel in 2nd line Non-squamous3 Docetaxel in 2nd line PD-L1 ≥ 1%2 Docetaxel in 2nd line Squamous1 Sacituzumab Govitecan in ≥3rd line4 Docetaxel in 2nd line Non-squamous3 Docetaxel in 2nd line PD-L1 ≥ 1%2 Docetaxel in 2nd line Squamous1 Sacituzumab Govitecan in ≥3rd line4

ORR

(%)

PFS

(months) 2.8 5.2

(N=54)

4.0 4.2

* Information is based on comparative results from independent studies Source of data: 1) Brahmer J, NEJM 2015; 2) Herbst RS, Lancet 2016; 3) Borghaei H, NEJM 2015; 4) Heist RS, JCO 2017

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SLIDE 30

Trop-2-Enriched Basket Study (TROPICS-03) to Unlock Full Potential of Sacituzumab Govitecan

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Continue treatment until progression

NSCLC, SCLC & H&N

  • 3rd line post CPI- and

chemotherapy

Endometrial

  • 2nd line post platinum-

based chemotherapy

Primary Endpoint

  • ORR

Secondary Endpoint

  • DoR, PFS, OS & Safety

Indication Endpoint

Sacituzumab govitecan 10 mg/kg IV day 1 & 8, every 21 days

Simon Two-Stage Design

Exploratory

  • Biomarker, QoL

Stage 1: 40 Patients per Indication Stage 2: 60 Additional Patients per Indication

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT03964727

  • Study initiated in July 2019 in U.S.
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SLIDE 31

T H E I M M U N O M E D I C S S T O R Y

Transforming the Treatment Paradigm for Complex Cancers

31

  • The company – at an inflection point
  • Lead product – establishing leadership in mTNBC
  • Our “pipeline in a product”
  • Next 3 major indications targeted
  • The future – 2019 and 2020 priorities and milestones
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SLIDE 32

Priorities for 2019 and 2020

32

Re-submit BLA for sacituzumab govitecan in mTNBC in early Q4 2019

1 2 3

Execute sacituzumab govitecan development plans to expand beyond ≥2nd line mTNBC Further scale & enhancement of manufacturing capabilities

4

Ensure highly efficient lean operating model is in place

5

Continue prudent financial management

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SLIDE 33

Indication Study Milestone

2019 2020

Q3 Q4 H1 H2

Third-Line mTNBC Phase 2 Estimated BLA re-submission Third-Line mTNBC Phase 3 ASCENT Top-line results Third-Line mUC Phase 2 TROPHY U-01 Complete patient enrollment Late-Line HR+/HER2‒ mBC Phase 3 TROPICS-02 Complete patient enrollment Refractory NSCLC, SCLC, HNSCC & endometrial Trop-2-Enriched Phase 2 TROPICS-03 Continue patient enrollment

Key Milestones by Program to Advance Sacituzumab Govitecan

33

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SLIDE 34

Sufficient Cash Runway to Pursue Strategic Priorities*

34 * Data as of June 30, 2019

Cash and marketable securities Convertible senior notes Basic shares outstanding (fully diluted) $433 million $7 million 192 (205) million

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SLIDE 35

I N S U M M A R Y

A Transformed Company with Momentum Building

35

At Inflection Point Building Differentiated Portfolio Momentum Building

  • Building fully integrated

biopharma company

  • New paradigm for treating

complex cancers

  • Multiple catalysts for

growth

$