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Corporate Overview November 2018 Science-Based Innovation-Focused ADC Company

Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

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Page 1: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Corporate OverviewNovember 2018

Science-Based

Innovation-Focused

ADC Company

Page 2: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

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.

Page 3: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Our Company Vision for Value Creation

3

Immunomedics is deeply

committed to become the leading

antibody-drug conjugate (ADC)

company worldwide delivering

breakthrough therapies to treat

complex cancers and transform

patient outcomes

Page 4: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

First-in-class ADC Platform

4

Linker for SN-38

SN-38 Payload

1. SN-38 more potent than parent compound, irinotecan

2. In xenograft models, ADC delivers up to 136-fold more SN-38 than irinotecan

Linker for SN-38

1. Hydrolysable linker for payload release

2. High drug-to-antibody ratio (7.5:1)

Suite of Humanized Antibodies for Creating ADCs

1. hRS7, used in sacituzumab govitecan, targets Trop-2 for solid cancers

2. Labetuzumab, used in IMMU-130, targets CEACAM5 for colorectal cancer

3. IMMU-114, used in IMMU-140, targets HLA-DR for solid and liquid cancers

Page 5: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Sacituzumab Govitecan, an Antibody-Drug Conjugate for Targeted Drug Delivery to Solid Cancers

5

• Target: Trop-2

– Pan-epithelial cancer antigen with broad expression in many different cancers

– ≥80% of patients have moderate to strong expression by immunohistochemistry

– Internalizes upon antibody binding - ideal target for drug delivery with antibody-drug conjugates

• Antibody: Humanized RS7-3G11

– Binds human breast, lung, colon, renal, prostate, urothelial, and many other solid cancers

Trop-2 expression in TNBC liver tumor biopsy

Page 6: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Significant Progress with Sacituzumab Govitecanvs. Key Milestones

6

• BLA submission for 3rd–line metastatic triple-negative breast cancer (mTNBC) accepted and granted Priority Review by FDA

– PDUFA date set for January 18, 2019

• Enhanced supply chain by entering into a long-term manufacturing partnership agreement with Samsung for commercial-scale production of hRS7

• Initiation of pivotal Phase 2 TROPHY U-01 study in metastatic urothelial cancer (mUC)

• Multiple clinical/preclinical collaborations to advance into earlier lines of treatment and other cancer indications

– AstraZeneca: sacituzumab govitecan + durvalumab combo in 1st–line mTNBC and mUC, and 2nd–line NSCLC

– Clovis: sacituzumab govitecan + rucaparib combo in 2nd–line mTNBC and mUC

– Yale: monotherapy in endometrial and cervical cancers

– Wisconsin: monotherapy in prostate cancer

– Preclinical studies in head and neck and prostate cancers

• Launch preparation ongoing, commercial manufacturing on track to meet demand

Page 7: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Building a Blockbuster Brand in Oncology

7

Cancer TypesLine of Therapy

3rd Line+ 2nd Line 1st Line (Neo)Adjuvant

mTNBC

mUCCisplatin-eligible

Cisplatin-ineligible

ER+ mBC

NSCLC

Mono

Mono

CPI comboMono/

PARPi combo

Mono

+PARPiMono

+PARPi

Planned Ongoing Evaluating

CPI combo

CPI combo

Mono/CPI combo

Mono

CPI combo

Mono

Page 8: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Sacituzumab Govitecan in Metastatic Triple-Negative

Breast Cancer

Page 9: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Low Response Rates in Pre-treated mTNBC*

9

Drug Phase N Population ORR (%) PFS (mos) OS (mos)

1st line treatment

Carboplatin1 3 188 1st line 31 3.1 12.4

Docetaxel1 3 188 1st line 36 4.5 12.3

Cisplatin/ Carboplatin2 2 86 1st line (80.2%) 25.6 2.9 11.0

>1st line treatment

Ixabepilone3 2 (pooled analysis)

60Resistant to anthracycline,

cyclophosphamide & taxane or taxane only

6 - 17 1.6 - 2.7 --

Capecitabine3 3 (pooled analysis)

208Prior or resistant to anthracycline

& taxane15 1.7 --

Eribulin4 3 (pooled analysis)

199 > 1 prior chemo 11 2.8 12.4

* Includes breast cancer drugs with data from Phase 2/3’s with minimum mTNBC sample size > 60; ORR and PFS data

Source of data: 1) Tutt A, SABCS 2014; 2) Isakoff SJ, J Clin Oncol 2015; 3) Perez EA, Breast Can Res Treat 2010; 4) Pivot X, Ann Oncol 2016

Page 10: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Adverse Events (Regardless of Causality)

10

• Adverse events were managed with supportive medication or dose modifications

– 25% of patients had dose modifications predominantly to 7.5 mg/kg

• Two patients (1.8%) discontinued due to adverse events (grade 3 transient infusion reaction/grade 2 fatigue)

• There were no treatment-related deaths

Body system Adverse event All grades Grade 3 or 4

Hematologic

Neutropenia 63% 41%

Febrile neutropenia 8% 7%

Anemia 52% 10%

Leukopenia 24% 14%

Gastrointestinal

Nausea 63% 5%

Diarrhea 56% 8%

Vomiting 46% 5%

Constipation 32% 1%

Other

Fatigue 50% 7%

Alopecia 36% NA

Decreased appetite 30% 0%

Hyperglycemia 23% 4%

Hypomagnesemia 21% 1%

Hypophosphatemia 15% 8%

Includes all events >20% (all grades) or >5% (grade 3 or 4); NA = not applicable

Page 11: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Sacituzumab Govitecan in Late-Line mTNBC

11

108 patients in BLA

• Patients received ≥3rd prior line for metastatic disease: 100%

• ORR: 33% (local), 32% (BICR)

• Median DoR: 8.3 months (local), 6.7 months (BICR)

• Median PFS: 5.5 months (local)

Percent Reduction in Baseline Target Lesions*

* Two patients did not meet the criteria of two prior therapies for metastatic disease and were not included in the BLA package

Page 12: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Amended ASCENT Phase 3 Study (under SPA): Overview

12

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT02574455. Accessed March 14, 2018.

• First patient dosed in November 2017 in U.S.

• SPA protocol accepted by EU regulatory authority

• Clinical trial accruing globally

1o Endpoint

• PFS ( BM-)

Sacituzumab govitecan 10 mg/kg IV

d1 & 8, every 3 wks

Treatment of physician choice

• Capecitabine• Eribulin• Gemcitabine• Vinorelbine

StratificationFactors

Continue treatment until progression

N = 488

mTNBC

(ASCO/CAP)

R/R after ≥2 prior SOC chemo for advanced disease

OR

1 therapy for advanced disease who also progressed within 12 months of (neo)adjuvant therapy

• # prior therapies• Geography• +/- known BM

(15% cap)

2o Endpoints

• OS (BM-)• PFS (ITT)• OS (ITT)

Page 13: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Triple-Negative Breast Cancer

13

BLA submittedPhase 3 confirmatory “ASCENT”

Potential for CPI or other combo

Planned OngoingEvaluating

Phase 2 single armPhase 1/2 PARPi combo

Neoadjuvant

Adjuvant

1st Line (10-11k Pts)

2nd Line (9-10k Pts)

3rd Line+(8-9k Pts)

Stage 3 locally advanced (unresectable), Stage 4 metastatic

Stage 1, 2 and 3 (resectable)

Phase 1/2 CPI combo Phase 2 single arm

Page 14: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Sacituzumab Govitecan in Advanced Urothelial Cancer

Page 15: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Low Response Rates in Relapsed / “Refractory” mUC

15

Treatment Phase ORR PFS (months) OS (months) Source

Historical ~10% 3 4-9

Vinflunine 3 8.6% 3.0 6.9Bellmunt

J Clin Oncol 2009

Docetaxel 2 8.9% 2.8 9.2Petrylak D

J Clin Oncol 2016

Docetaxel + Ramucirumab

2 24% 5.4 10.4Petrylak D

J Clin Oncol 2016

Docetaxel 3 14% 2.8 Not ReportedPetrylak D

Lancet 2017

Docetaxel + Ramucirumab

3 24.5% 4.1 Not ReportedPetrylak D

Lancet 2017

Page 16: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Sacituzumab Govitecan in ≥2nd Line mUC

16

41 patients enrolled•Median number of prior

lines: 3 (range, 1‐6)•ORR: 34% (14/41)

– Prior CPI: 29% (4/14)•Median duration of

response: 12.6 months (95% CI: 7.5, 12.9)

• Clinical benefit rate (CR+PR+SD≥6 months): 49%

Percent Reduction in Baseline Target Lesions

-1 0 0

-8 0

-6 0

-4 0

-2 0

0

2 0

4 0

6 0

Be

st

Re

sp

on

se

Be

st

% c

ha

ng

e i

n

TL

fro

m b

as

eli

ne

SD

PD

C o m p le te re s p o n s e

P a r t ia l re s p o n s e

S ta b le d is e a s e

P r o g r e s s io n

P rio r c h e c k p o in t in h ib ito r T x

72% (26/36) of patients with at least one CT response assessment had reduction of target lesions (sum of diameters)

Tagawa et al, Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Page 17: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Cohort 1: N = 100

Cohort 2: N = 40

mUC Phase 2 Pivotal TROPHY U-01 Study Overview

17

• Patients will be enrolled across approximately 50 sites in North America and Europe

1o Endpoint

• ORR (BICR)

Sacituzumab govitecan 10 mg/kg IV

d1 & 8, every 3 wks

Continue treatment until progression

mUC

Cohort 1: 3rd line post platinum-and PD-1/PD-L1 based therapies

OR

Cohort 2: 2nd line for cisplatin-ineligible patients

2o Endpoints

• DoR• PFS• OS

Page 18: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Metastatic Urothelial Cancer

18

Planned

TROPHY U-01 StudyPhase 1/2 PARPi combo

TROPHY U-01 Study

Cisplatin eligible Cisplatin ineligible

Phase 1/2 PARPi combo

1st Line(10-12k Pts)

2nd Line(7-8k Pts)

3rd Line+(3-4k Pts)

1st Line(8-10k Pts)

2nd Line(6-7k Pts)

3rd Line+(3-4k Pts)

Ongoing

Phase 1/2 CPI combo

Evaluating

Phase 1/2 CPI combo

TROPHY U-01 Study

Page 19: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Sacituzumab Govitecan in ER+/HER2– Metastatic

Breast Cancer

Page 20: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Estrogen-Receptor Positive/HER2-Negative mBC

20

• Most common form of mBC in the U.S.

• Treatments involve:

– Initially endocrine-based therapies, including CDK 4/6 inhibitors

– Subsequently chemotherapy, but response rates to later-line therapies are low

• Poor prognosis for patients with visceral metastases

• New therapeutic options needed for treatment-refractory ER+/HER2– mBC

61%17%

9%

13%ER+/HER2negER+/HER2+ERneg/HER2+TNBC

U.S. Stage 4 Breast Cancer Prevalent Population Distribution by Subtype (SEER)

Page 21: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Low Response Rates to Chemotherapy in Pre-Treated mBC

21

A: Anthracycline; T: Taxane. *N represents mBC population which includes HER2+ and/or TNBC; ORRs are based on local review. ** TTF

Drug N* Population HR+ % ORR %PFS

(months)OS

(months)Source

Ixabepilone 126Prior A, T and capecitabine

52 18.3 3.1 8.6 Perez EA JCO 2007

Capecitabine 548Prior A, T

≤ 3 prior chemo (incl. adjuvant)

47 19.9 4.2 14.5 Kaufman PAJCO 2015

Capecitabine

ER+ subgroup219 Idem 100 NA 5.3 16.8

Twelves C, Breast Cancer Research,

2016

Eribulin

ER+ subgroup198 Idem 100 NA 4.3 18.2

Twelves C, Breast Cancer Research,

2016

Eribulin 508Prior A and T

≥2 prior chemo64 13 3.7 13.1 Cortes J

Lancet 2010

Vinorelbine 115 Prior A, ≤ 2 lines 51 13 3** 7.5 JonesJCO 1995

Page 22: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Single-Arm, Open-Label Study Design

22

Evaluations

• Response by local assessment (RECIST v1.1)

• Other: safety

Sacituzumab govitecan 10 mg/kg IV

d1 & 8, every 3 wks

Continue treatment until progression/

unacceptable toxicity

ER+/HER2– mBCat last biopsy

Key Eligibility Criteria

• Adults, ≥18 years of age

• ECOG: 0-1

• ≥1 prior metastatic therapies

• Measurable disease

Page 23: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Demographics and Patient Characteristics (N=54)

23

*Includes lines of therapy given in the (neo)adjuvant setting if patient became metastatic within 12 months (N=4)**Metastatic sites in >20% patients; 89% (48/54) of patients had liver or lung metastases

Taxane – any setting

Anthracycline – any setting

93%

69%

CDK 4/6 inhibitors

mTOR inhibitors

69%

54%

Prior chemotherapy for metastatic disease

Fluoropyrimidine agents

Taxane

Eribulin

Platinum agents

80%

57%

33%

24%

Sites of metastatic disease at study entry**

Bone

Liver

Chest

Lung

80%

82%

37%

31%

Female/male, n 54/0

Median age, years (range) 54 (33-79)

ECOG performance status

0

1

Missing

35%

56%

9%

Median time from metastatic disease to study entry, years

3.50

≥ 1 prior chemotherapy line for metastatic disease

Median number of metastatic chemotherapy lines

Median number of metastatic hormonal therapy lines

Median number of prior metastatic treatment lines

Hormonal therapy for metastatic disease

≥ 3 lines of hormonal therapy for metastatic disease

98%

2 (0-9)*

3 (1-6)*

5 (2-17)*

100%*

67%*

Page 24: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Adverse Events (Regardless of Causality) All events >20% or Grade 3+ >5%

24

** AE frequency based on the available reporting of 50/54 pts. AE data for the remaining 4/54 patients are being collected

Body system Adverse event (AE) All grades* Grade 3 or 4*

Hematologic

Neutropenia

Febrile neutropenia

Anemia

Leukopenia

64%

2%

36%

16%

42%

2%

6%

8%

Gastrointestinal

Nausea

Diarrhea

Vomiting

Constipation

58%

40%

38%

30%

2%

4%

4%

0%

Other

Fatigue

Alopecia

Decreased appetite

Cough

Alk Phos increase

Hypophosphatemia

46%

36%

28%

22%

20%

16%

2%

NA

0%

0%

6%

8%

• AEs managed with supportive medication or dose modifications

– 28% received growth factor support

• 22% of patients had dose reduced to 7.5 mg/kg; 9% occurring in 1st cycle

• Two patients (3.7%) discontinued due to AEs (grade 3 neutropenia not recovered within 3 weeks; grade 3 diarrhea/ dehydration)

• No treatment-related deaths

Page 25: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

-8 0

-6 0

-4 0

-2 0

0

2 0

4 0

Be

st

Re

sp

on

se

(% c

ha

ng

e i

n t

arg

et

les

ion

fro

m b

as

eli

ne

)

P a r t ia l re s p o n s e

S ta b le d is e a s e

P r o g r e s s io n

6 p ts w ith o u t C T a s s e s s m e n t a re n o t s h o w n

+ C o n tin u in g tre a tm e n t

+

+

+++

++

++

+

+

Tumor Response to Sacituzumab Govitecan

25

• 63% (34/54) of patients with at least one CT response assessment had reduction of target lesions (sum of diameters)

• Median number of metastatic chemo lines: 2

• Median number of prior metastatic lines: 5

Local Response Evaluation by RECIST1.1

Objective response rate

CR

PR

31% (17/54)

0

17

Clinical benefit rate (CR+PR+SD ≥6 months)

48% (26/54)

Page 26: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Response Onset and Durability (N=17)

26

0 4 8 1 2 1 6

M o n th s fro m s ta rt o f s a c itu z u m a b g o v ite c a n

C o n t in u in g

O n s e t o f re s p o n s e

// (2 6 .1 )

P r io r C D K 4 /6

in h ib ito r

N o p r io r C D K 4 /6

in h ib ito r

• Median duration of response: 7.4 months (95% CI: 4.4, 18.3)

• Median time to onset of response: 2.3 months (range: 1.5-7.8)

• 7 responders were still receiving sacituzumab govitecan at last assessment

Best response under RECIST 1.1, as per local assessment

Page 27: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Progression-Free Survival (PFS)

27

Based on Local Assessment

using RECIST 1.1

Median PFS, months

(95% CI)

6.8

(4.6, 8.9)

0

20

40

60

80

100

0 4 8 12 16 20 24 28

Months

Su

rviv

al

pro

bab

ilit

y (

%)

Number at risk

49 29 13 3 2 1 1 0

• 32 patients had objective progression (maturity = 59%)

• 10 patients are continuing• 12 other patients censored

– 5 with no CT assessment were censored at baseline

– 1 withdrew at 0.7 months after leaving study with AE

– The remaining censored pts left study with their last response assessment SD or better

Page 28: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Response to Sacituzumab Govitecan in Subgroups

28

**Includes lines of therapy given in the (neo)adjuvant setting if patient became metastatic within 12 months (N=4)

ORR, % (n/N)

Onset of metastatic disease from diagnosis

< 1 year

≥ 1 year

15% (2/13)

37% (15/41)

≥ 2 prior chemo for metastatic disease*

< 2 prior chemo for metastatic disease*

29% (12/41)

38% (5/13)

≥ 3 prior hormonal therapies for metastatic disease*

< 3 prior hormonal therapies for metastatic disease*

25% (9/36)

44% (8/18)

Prior CDK 4/6 inhibitors

No prior CDK 4/6 inhibitors

24% (9/37)

47% (8/17)

ORR, % (n/N)

Overall 31% (17/54)

Age

<65

≥65

29% (12/42)

42% (5/12)

Visceral involvement at study entry (Liver/Lung)

Yes

No

27% (13/48)

67% (4/6)

Liver involvement

Clinical Benefit Rate in patients with liver involvement (CR+PR+SD ≥6 months)

27% (12/44)

48% (21/44)

Page 29: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

ER+/HER2– Breast Cancer

29

Stage 3 locally advanced (unresectable), Stage 4 metastatic

Pivotal study

Endocrine & CDK 4/6i Therapy

1st Line Chemo (30-33k Pts)

2nd Line Chemo(26-28k Pts)

3rd Line Chemo(24-26k Pts)

Planned OngoingEvaluating

Page 30: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Sacituzumab Govitecan in Metastatic Non-Small Cell Lung

Cancer

Page 31: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Low Response Rates for Chemotherapy in Previously-Treated mNSCLC

31

Treatment Phase N ORRPFS

(months)OS

(months)Source

Docetaxelin 2nd-line

Non-squamous3 290 12% 4.2 9.4

Borghaei et al.N Engl J Med 2015

373:1627-39

Docetaxelin 2nd-line Squamous

3 137 9% 2.8 6.0Brahmer et al.;

N Engl J Med 2015373:123-135

Docetaxelin 2nd-line

PD-L1 ≥ 1%3 343 9% 4.0 8.5

Herbst et al.Lancet 2016

387(10027):1540-50

Page 32: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Sacituzumab Govitecan in Pretreated mNSCLC

32

54 patients enrolled•Median number of prior

lines: 3 (range, 2‐7)•ORR: 19% (9/47)

– Prior CPI: 14% (2/14)•Median duration of

response: 6.0 months (95% CI: 4.8, 8.3)

• Clinical benefit rate (CR+PR+SD≥6 months): 32%

Percent Reduction in Baseline Target Lesions

Heist et al, Journal of Clinical Oncology 35(24):2790-2797, 2017

-8 0

-6 0

-4 0

-2 0

0

2 0

4 0

Be

st

% c

ha

ng

e i

n

targ

et

les

ion

s f

rom

ba

se

lin

e

P a rt ia l re s p o n s e (c o n firm e d ) (P R )

U n c o n firm e d P R (P R u ) (s ta b le d is e a s e )

S ta b le d is e a s e

P r o g r e s s io n

S q u a m o u s c e ll h is to lo g y

8 m g /k g s ta r t in g d o s e

P r io r c h e c k p o in t in h ib ito r T x

+

+ e a rly C T a s s e s s m e n t a fte r 2 d o s e s

Page 33: Science-Based Innovation-Focused ADC Company · 2016 Eribulin ER+ subgroup 198 Idem 100 NA 4.3 18.2 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T ≥2 prior chemo

Non-Small Cell Lung Cancer

33

Stage 3 locally advanced (unresectable), Stage 4 metastatic

Pivotal study

1st Line Chemo + CPI Combo (100-120k Pts)

2nd Line Chemo(75-85k Pts)

3rd Line Chemo(35-45k Pts)

Planned OngoingEvaluating

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Additional Corporate Information

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Sacituzumab govitecan/IMMU-132 (anti-Trop-2-SN-38 ADC)

Metastatic triple-negative breast cancer (FDA granted BTD)

IMMU-140 (anti-HLA-DR-SN-38 ADC)

Labetuzumab govitecan/IMMU-130 (anti-CEACAM5-SN-38 ADC)

Metastatic urothelial cancer Pivotal

Metastatic colorectal cancer

Solid and liquid cancers

First-in-Class Antibody-Drug Conjugate (ADC) Programs

Other Product Candidates include Epratuzumab, Veltuzumab, Milatuzumab and IMMU-114 for Oncology and Autoimmune Disease Indications

Research/Preclinical Phase 1 Phase 2 Phase 3

Solid tumors IITs

FDA Review

Metastatic ER+/HER2- breast cancer

Broad Pipeline of ADC Therapies

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Registration

BLA

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Sufficient Cash Runway to Pursue Strategic Priorities

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Debt (convertible senior notes) $20 Million

Basic shares outstanding (fully diluted) 187 (205) Million

Cash balance as of 9/30/2018 $586 Million