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Innovation-Focused ADC Company Corporate Overview September 2018 - PowerPoint PPT Presentation

Science-Based Innovation-Focused ADC Company Corporate Overview September 2018 Forward-Looking Statements This presentation, in addition to historical information, contains certain forward- looking statements made pursuant to the Private


  1. Science-Based Innovation-Focused ADC Company Corporate Overview September 2018

  2. 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 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 Linker for SN-38 cancers Linker for SN-38 1. Hydrolysable linker for payload SN-38 Payload release 1. SN-38 more potent than 2. High drug-to-antibody ratio (7.5:1) parent compound, irinotecan 2. In xenograft models, ADC delivers up to 136-fold more SN-38 than irinotecan 4

  5. Sacituzumab Govitecan, an Antibody-Drug Conjugate for Targeted Drug Delivery to Solid Cancers • Target: Trop-2 Trop-2 expression in TNBC liver – Pan-epithelial cancer antigen with broad tumor biopsy 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 5

  6. Significant Progress with Sacituzumab Govitecan vs. Key Milestones BLA submission for 3 rd – 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/MedImmune: sacituzumab govitecan + durvalumab combo in 1 st – line mTNBC and mUC – Clovis: sacituzumab govitecan + rucaparib combo in 2 nd – 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 • 6

  7. Building a Blockbuster Brand in Oncology Line of Therapy Cancer Types 3 rd Line+ 2 nd Line 1 st Line (Neo)Adjuvant Mono Mono/ mTNBC CPI combo Mono PARPi combo CPI combo Cisplatin-eligible Mono +PARPi CPI combo mUC Cisplatin-ineligible Mono Mono +PARPi CPI combo ER+ mBC Mono NSCLC Mono/CPI combo Evaluating Planned Ongoing 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 1 st line Carboplatin 1 3 188 31 3.1 12.4 1 st line Docetaxel 1 3 188 36 4.5 12.3 Cisplatin/ 1 st line (80.2%) 2 86 25.6 2.9 11.0 Carboplatin 2 >1st line treatment Resistant to anthracycline, 2 (pooled Ixabepilone 3 60 cyclophosphamide & taxane or 6 - 17 1.6 - 2.7 -- analysis) taxane only 3 (pooled Prior or resistant to anthracycline Capecitabine 3 208 15 1.7 -- analysis) & taxane 3 (pooled Eribulin 4 199 > 1 prior chemo 11 2.8 12.4 analysis) * 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 9

  10. Adverse Events (Regardless of Causality) Body system Adverse event All grades Grade 3 or 4 Neutropenia 63% 41% Febrile neutropenia 8% 7% Hematologic Anemia 52% 10% Leukopenia 24% 14% Nausea 63% 5% Diarrhea 56% 8% Gastrointestinal Vomiting 46% 5% Constipation 32% 1% Fatigue 50% 7% Alopecia 36% NA Decreased appetite 30% 0% Other 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 Percent Reduction in Baseline Target Lesions* • 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) * 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 Sacituzumab govitecan (ASCO/CAP) 10 mg/kg IV d1 & 8, every 3 wks R/R after ≥2 prior SOC chemo N = 488 for advanced disease Continue treatment until progression OR Stratification Treatment of physician choice  1 therapy for advanced Factors • Capecitabine disease who also progressed • Eribulin • # prior therapies within 12 months of 1 o Endpoint 2 o Endpoints • Gemcitabine • Geography (neo)adjuvant therapy • Vinorelbine • OS (BM-) • +/- known BM • PFS ( BM-) • PFS (ITT) (15% cap) • 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. https://clinicaltrials.gov/ct2/show/NCT02574455. Accessed March 14, 2018. 12

  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 1 st Line (10-11k Pts) Phase 2 single arm Phase 1/2 CPI combo Phase 2 single arm 2 nd Line (9-10k Pts) Phase 1/2 PARPi combo BLA submitted 3rd Line+ Phase 3 confirmatory “ASCENT” (8-9k Pts) 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% 3 4-9 Bellmunt Vinflunine 3 8.6% 3.0 6.9 J Clin Oncol 2009 Petrylak D Docetaxel 2 8.9% 2.8 9.2 J Clin Oncol 2016 Docetaxel + Petrylak D 2 24% 5.4 10.4 Ramucirumab J Clin Oncol 2016 Petrylak D Docetaxel 3 14% 2.8 Not Reported Lancet 2017 Docetaxel + Petrylak D 3 24.5% 4.1 Not Reported Ramucirumab Lancet 2017 15

  16. Sacituzumab Govitecan in ≥2 nd Line mUC Percent Reduction in Baseline Target Lesions 41 patients enrolled • Median number of prior 6 0 C o m p le te re s p o n s e lines: 3 (range, 1‐6) P a rtia l re s p o n s e B e s t % c h a n g e in T L fro m b a s e lin e S ta b le d is e a s e 4 0 • ORR: 34% (14/41) P r o g r e s s io n  2 0  – Prior CPI: 29% (4/14) P rio r c h e c k p o in t in h ib ito r T x  B e s t R e s p o n se  S D P D • Median duration of 0      response: 12.6 months -2 0   (95% CI: 7.5, 12.9) -4 0   • Clinical benefit rate -6 0  (CR+PR+SD≥6 months): -8 0 72% (26/36) of patients with at least one CT response assessment had reduction of target lesions (sum of diameters) 49% -1 0 0 Tagawa et al, Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371 16

  17. mUC Phase 2 Pivotal TROPHY U-01 Study Overview mUC Cohort 1: 3rd line post platinum- Cohort 1: N = 100 Sacituzumab govitecan and PD-1/PD-L1 based therapies Continue treatment until 10 mg/kg IV progression OR d1 & 8, every 3 wks Cohort 2: N = 40 Cohort 2: 2nd line for cisplatin- ineligible patients 1 o Endpoint 2 o Endpoints • ORR • DoR (BICR) • PFS • OS • Patients will be enrolled across approximately 50 sites in North America and Europe 17

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

  19. Sacituzumab Govitecan in ER+/HER2 – Metastatic Breast Cancer

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