Science-Based Innovation-Focused ADC Company. Corporate Overview June 2018

Transcription

1 Science-Based Innovation-Focused ADC Company Corporate Overview June 2018

2 Forward-Looking Statements This presentation, in addition to historical information, contains certain forwardlooking statements made pursuant to the Private Securities Litigation Reform Act of 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. 2

3 Our Company Vision for Value Creation 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 3

4 First-in-class ADC Platform 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 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 Hydrolysable linker for payload release 2. High drug-to-antibody ratio (7.5:1) 4

5 Sacituzumab Govitecan, an Antibody-Drug Conjugate for Targeted Drug Delivery to Solid Cancers 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 Trop-2 expression in TNBC liver tumor biopsy Antibody: Humanized RS7-3G11 Binds human breast, lung, colon, renal, prostate, urothelial, and many other solid cancers 5

6 Significant Progress with Sacituzumab Govitecan vs. Key Milestones Submission of BLA for metastatic triple-negative breast cancer (mtnbc) on May 18, 2018 Oral ASCO presentation of Phase 1/2 study in estrogen receptor-positive metastatic breast cancer (ER+ mbc) Initiation of pivotal Phase 2 TROPHY U-01 study in metastatic urothelial cancer (muc) Announcement of clinical partnership with Clovis to develop the combination of sacituzumab govitecan and rucaparib in mtnbc and muc Implementation of protocol changes under revised SPA to further improve probability of success for ongoing Phase 3 ASCENT study in 3 rd -line mtnbc Launch preparation underway, commercial manufacturing on track to meet demand 6

7 Building a Blockbuster Brand in Oncology Cancer Types Line of Therapy 3 rd Line+ 2 nd Line 1 st Line (Neo)Adjuvant mtnbc Mono Mono/ PARPi combo Mono CPI combo CPI combo muc Cisplatin- eligible Cisplatin-ineligible Mono +PARPi Mono CPI combo Mono +PARPi CPI combo ER+ mbc Mono NSCLC Mono/CPI combo Ongoing Planned Evaluating 7

8 Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer

9 Low Response Rates in Pre-treated mtnbc* Drug Phase N Population ORR (%) PFS (mos) OS (mos) 1st line treatment Carboplatin st line Docetaxel st line Cisplatin/ Carboplatin st line (80.2%) Ixabepilone 3 2 (pooled analysis) 60 >1st line treatment Resistant to anthracycline, cyclophosphamide & taxane or taxane only Capecitabine 3 3 (pooled analysis) 208 Prior or resistant to anthracycline & taxane Eribulin 4 3 (pooled analysis) 199 > 1 prior chemo * 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

10 Adverse Events (Regardless of Causality) Body system Adverse event All grades Grade 3 or 4 Neutropenia 63% 41% Hematologic Febrile neutropenia 8% 7% Anemia 52% 10% Leukopenia 24% 14% Nausea 63% 5% Gastrointestinal Diarrhea 56% 8% Vomiting 46% 5% Constipation 32% 1% Fatigue 50% 7% Alopecia 36% NA Other 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 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 10

11 Sacituzumab Govitecan in Late-Line mtnbc 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 11

12 Amended ASCENT Phase 3 Study (under SPA): Overview 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 N = 488 Stratification Factors # prior therapies Geography +/- known BM (15% cap) Sacituzumab govitecan 10 mg/kg IV d1 & 8, every 3 wks Treatment of physician choice Capecitabine Eribulin Gemcitabine Vinorelbine Continue treatment until progression 1 o Endpoint PFS ( BM-) 2 o Endpoints OS (BM-) PFS (ITT) OS (ITT) First patient dosed in November 2017 in U.S. SPA protocol accepted by EU regulatory authority Clinical trial accruing globally National Institutes of Health. Accessed March 14,

13 Triple-Negative Breast Cancer Stage 1, 2 and 3 (resectable) Neoadjuvant Potential for CPI or other combo Adjuvant Stage 3 locally advanced (unresectable), Stage 4 metastatic Phase 1/2 CPI combo 1 st Line (10-11k Pts) Phase 2 single arm 2 nd Line (9-10k Pts) 3rd Line+ (8-9k Pts) Phase 2 single arm Phase 1/2 PARPi combo BLA submitted Phase 3 confirmatory ASCENT Evaluating Planned Ongoing 13

14 Sacituzumab Govitecan in Advanced Urothelial Cancer

15 Low Response Rates in Relapsed / Refractory muc Treatment Phase ORR PFS (months) OS (months) Source Historical ~10% Vinflunine 3 8.6% Docetaxel 2 8.9% Bellmunt J Clin Oncol 2009 Petrylak D J Clin Oncol 2016 Docetaxel + Ramucirumab 2 24% Petrylak D J Clin Oncol 2016 Docetaxel 3 14% 2.8 Not Reported Petrylak D Lancet 2017 Docetaxel + Ramucirumab % 4.1 Not Reported Petrylak D Lancet

16 B e s t R e s p o n s e B e s t % c h a n g e in T L fr o m b a s e lin e S D P D Sacituzumab Govitecan in 2 nd Line muc 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 C o m p le te r e s p o n s e P a r tia l r e 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-v /annonc/mdx371 16

17 muc Phase 2 Pivotal TROPHY U-01 Study Overview muc Cohort 1: 3rd line post platinumand PD-1/PD-L1 based therapies OR Cohort 2: 2nd line for cisplatinineligible patients Cohort 1: N = 100 Cohort 2: N = 40 Sacituzumab govitecan 10 mg/kg IV d1 & 8, every 3 wks Continue treatment until progression 1 o Endpoint 2 o Endpoints ORR (BICR) DoR PFS OS Patients will be enrolled across 60 sites in North America and Europe 17

18 Metastatic Urothelial Cancer Cisplatin eligible Cisplatin ineligible 1 st Line (8-10k Pts) 1 st Line (10-12k Pts) Potential for CPI combo Potential for CPI combo 2 nd Line (6-7k Pts) Phase 1/2 PARPi combo 2 nd Line (7-8k Pts) TROPHY U-01 Study Phase 1/2 PARPi combo 3rd Line+ (3-4k Pts) TROPHY U-01 Study 3rd Line+ (3-4k Pts) TROPHY U-01 Study Evaluating Planned Ongoing 18

19 Sacituzumab Govitecan in ER+/HER2 Metastatic Breast Cancer

20 Estrogen-Receptor Positive/HER2-Negative mbc 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 U.S. Stage 4 Breast Cancer Prevalent Population Distribution by Subtype (SEER) 9% 17% 13% 61% ER+/HER2neg ER+/HER2+ ERneg/HER2+ TNBC New therapeutic options needed for treatment-refractory ER+/HER2 mbc 20

21 Low Response Rates to Chemotherapy in Pre-Treated mbc Drug N* Population HR+ % ORR % PFS (months) OS (months) Source Ixabepilone 126 Prior A, T and capecitabine Perez EA JCO 2007 Capecitabine 548 Capecitabine ER+ subgroup Eribulin ER+ subgroup Prior A, T 3 prior chemo (incl. adjuvant) Idem 100 NA Idem 100 NA Kaufman PA JCO 2015 Twelves C, Breast Cancer Research, 2016 Twelves C, Breast Cancer Research, 2016 Eribulin 508 Prior A and T 2 prior chemo Cortes J Lancet 2010 Vinorelbine 115 Prior A, 2 lines ** 7.5 Jones JCO 1995 A: Anthracycline; T: Taxane. *N represents mbc population which includes HER2+ and/or TNBC; ORRs are based on local review. ** TTF 21

22 Single-Arm, Open-Label Study Design ER+/HER2 mbc at last biopsy Sacituzumab govitecan 10 mg/kg IV d1 & 8, every 3 wks Continue treatment until progression/ unacceptable toxicity Key Eligibility Criteria Adults, 18 years of age ECOG: prior metastatic therapies Measurable disease Evaluations Response by local assessment (RECIST v1.1) Other: safety 22

23 Demographics and Patient Characteristics (N=54) Female/male, n 54/0 Median age, years (range) 54 (33-79) ECOG performance status 0 1 Missing 35% 56% 9% Taxane any setting Anthracycline any setting CDK 4/6 inhibitors mtor inhibitors 93% 69% 69% 54% Median time from metastatic disease to study entry, years 1 prior chemotherapy line for metastatic disease % Prior chemotherapy for metastatic disease Fluoropyrimidine agents Taxane Eribulin Platinum agents 80% 57% 33% 24% 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 2 (0-9)* 3 (1-6)* 5 (2-17)* 100%* 67%* Sites of metastatic disease at study entry ** Bone Liver Chest Lung 80% 82% 37% 31% *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 23

24 Adverse Events (Regardless of Causality) All events >20% or Grade 3+ >5% Body system Adverse event (AE) All grades* Grade 3 or 4* Hematologic Gastrointestinal Other Neutropenia Febrile neutropenia Anemia Leukopenia Nausea Diarrhea Vomiting Constipation Fatigue Alopecia Decreased appetite Cough Alk Phos increase Hypophosphatemia 64% 2% 36% 16% 58% 40% 38% 30% 46% 36% 28% 22% 20% 16% 42% 2% 6% 8% 2% 4% 4% 0% 2% NA 0% 0% 6% 8% ** AE frequency based on the available reporting of 50/54 pts. AE data for the remaining 4/54 patients are being collected 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 1 st 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 24

25 B e s t R e s p o n s e (% c h a n g e in ta rg e t le s io n fro m b a s e lin e ) Tumor Response to Sacituzumab Govitecan Local Response Evaluation by RECIST1.1 Objective response rate CR PR 31% (17/54) Clinical benefit rate (CR+PR+SD 6 months) 48% (26/54) P a r tia l r e 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 r e n o t s h o w n + C o n tin u in g tre a tm e n t % (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 25

26 Response Onset and Durability (N=17) // (2 6.1 ) Median duration of response: 7.4 months (95% CI: 4.4, 18.3) N o p r io r C D K 4 /6 in h ib ito r P r io r C D K 4 /6 in h ib ito r C o n tin u in g O n s e t o f r e s p o n s e Median time to onset of response: 2.3 months (range: ) 7 responders were still receiving sacituzumab govitecan at last assessment 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 Best response under RECIST 1.1, as per local assessment 26

27 Progression-Free Survival (PFS) Months Number at risk Based on Local Assessment using RECIST 1.1 Median PFS, months (95% CI) 6.8 (4.6, 8.9) 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 27

28 Response to Sacituzumab Govitecan in Subgroups ORR, % (n/n) Overall 31% (17/54) Age <65 65 Visceral involvement at study entry (Liver/Lung) Yes No Liver involvement 29% (12/42) 42% (5/12) 27% (13/48) 67% (4/6) 27% (12/44) Onset of metastatic disease from diagnosis < 1 year 1 year 2 prior chemo for metastatic disease* < 2 prior chemo for metastatic disease* 3 prior hormonal therapies for metastatic disease* < 3 prior hormonal therapies for metastatic disease* ORR, % (n/n) 15% (2/13) 37% (15/41) 29% (12/41) 38% (5/13) 25% (9/36) 44% (8/18) Clinical Benefit Rate in patients with liver involvement (CR+PR+SD 6 months) 48% (21/44) Prior CDK 4/6 inhibitors No prior CDK 4/6 inhibitors 24% (9/37) 47% (8/17) **Includes lines of therapy given in the (neo)adjuvant setting if patient became metastatic within 12 months (N=4) 28

29 ER+/HER2 Breast Cancer Stage 3 locally advanced (unresectable), Stage 4 metastatic Endocrine & CDK 4/6i Therapy 1 st Line Chemo (30-33k Pts) Pivotal study 2 nd Line Chemo (26-28k Pts) 3rd Line Chemo (24-26k Pts) Evaluating Planned Ongoing 29

30 Additional Corporate Information

31 Broad Pipeline of ADC Therapies Research/Preclinical Phase 1 Phase 2 Phase 3 First-in-Class Antibody-Drug Conjugate (ADC) Programs Sacituzumab govitecan/immu-132 (anti-trop-2-sn-38 ADC) Metastatic triple-negative breast cancer (FDA granted BTD) Metastatic urothelial cancer Pivotal Metastatic ER+/HER2- breast cancer Solid tumors IITs FDA Review BLA Registration Labetuzumab govitecan/immu-130 (anti-ceacam5-sn-38 ADC) Metastatic colorectal cancer IMMU-140 (anti-hla-dr-sn-38 ADC) Solid and liquid cancers Other Product Candidates include Epratuzumab, Veltuzumab, Milatuzumab and IMMU-114 for Oncology and Autoimmune Disease Indications 31

32 Sufficient Cash Runway to Pursue Strategic Priorities Cash balance as of 3/31/2018 $359 Million Net proceed from equity offering (6/2018) $260 Million Pro forma cash balance as of 3/31/2018 $619 Million Debt (convertible senior notes) $20 Million Pro forma basic shares outstanding (fully diluted) 179 (202) Million 32