Investor Presentation March 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 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
Strong Foundation to Deliver Breakthrough Therapies for Hard-to-Treat Cancers 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 Patient-centric Science-based Performance-driven Quality Obsessed We Before Me Put patients at the heart Make all decisions Deliver results, create Pursue the highest Embrace diversity, of all we do through science sustainable value quality treat with respect OUR WAY 3
Unique ADC (1) Platform with Late-Stage Assets Targeting Multiple Underserved Indications Science with Lead product – depth & breadth Compelling targeting late-line Potential Two ADCs in across multiple benefit:risk triple-negative markets pipeline hard-to-treat solid profile breast cancer tumor indications 9+ potential Combinations For additional Multi-billion Re-submit indications for for earlier solid and dollar BLA in 2019 sacituzumab treatment liquid tumor opportunity govitecan lines indications Notes: 1. Antibody Drug Conjugate 4
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 • 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 priorities and milestones 5
Immunomedics Today – Transitioning to Fully Integrated, Biopharma Company Strong Seasoned Well Growing Building Integrated IP Portfolio Leadership Team Financed Global Biotech Market Value • Experts in • Cash on hand • Multi billion dollar • Lead ADC • Global manufacturing, $498M as of market cap protected until development & global drug 12/31/2018 generating 2033 regulatory teams development & significant • Funds strategic • 44 active U.S. • Global supply commercialization shareholder value priorities through and 30 foreign chain & mfg. over the last 2 • Track record of 2020 patents years • Core commercial developing and infrastructure launching blockbuster drugs 6
A Powerful Differentiated ADC Platform: Three Key Advantages 1. Payload – Validated & Well 2. Novel Linker Tolerated • Hydrolyzable linker for payload • ADC platform uses SN-38 as release payload of choice • Allows for intra- and extra-cellular • SN-38 kills cancer cells by (bystander-effect) killing of tumor damaging DNA cells 3. Antibody – Highly Tumor Specific • hRS7 in sacituzumab govitecan targets Trop-2 in multiple solid tumor indications • Other pipeline assets: labetuzumab govitecan targets CEACAM5, IMMU-140 targets HLA-DR 7
Broad Pipeline of Differentiated ADC Therapies Compound Indication Research / Preclinical Phase 1 Phase 2 Phase 3 Approval mTNBC (3L+) Re-submit BLA mTNBC (3L) – ASCENT Urothelial (3L) – TROPHY U-01 Sacituzumab HR+/HER2‒ mBC govitecan (IMMU-132) CPI combo (mBC / mUC / mNSCLC) PARPi combo (mBC / mUC / ovarian) Basket (mNSCLC / H&N / mSCLC / endometrial / HCC) IMMU-130 CRC IMMU-140 Hematologic cancers 8
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 • 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 priorities and milestones 9
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 2019 10
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 * ORR PFS (%) (months) 33 5.5 (N=108) (N=108) 18 2.8 2.7 15 11 1.7 Capecitabine Eribulin in Capecitabine Sacituzumab Eribulin in Taxane, Cap, Taxane, Cap, Sacituzumab in 2 nd line 2 2 nd line 1 in 2 nd line 2 2 nd line 1 Gem or Vin in Govitecan in Gem or Vin in Govitecan in 2 nd line 3 ≥3 rd line 4 2 nd line 3 ≥3 rd line 4 * Information is based on comparative results from independent studies 11 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
Manageable and Predictable Safety Profile Allows for Repeated Dosing Grades 3 and 4 Adverse Events Occurring in >5% of Patients mTNBC Population (N=108) Overall Safety Population (N=420) Adverse Event Grade 3 (%) Grade 4 (%) Grade 3 (%) Grade 4 (%) Blood and lymphatic system Neutropenia 26 16 25 13 Anemia 11 0 11 0 General and administration-site Fatigue and asthenia 8 0 11 0 Gastrointestinal Diarrhea 8 0 9 0 Nausea 6 0 5 0 Vomiting 6 0 4 0 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 12
mTNBC Confirmatory Study of Sacituzumab Govitecan vs. Physicians’ Choice (ASCENT) is Well Underway Amended ASCENT Phase 3 Study (under SPA): Overview Indication Twin Arm Study Endpoint mTNBC Sacituzumab govitecan Continue treatment 10 mg/kg IV ≥2 prior treatments until progression day 1 & 8, every 21 days OR N = 488 1 therapy for advanced Primary Endpoint disease who also • PFS Traditional chemotherapy progressed within 12 treatment of Secondary Endpoint months of (neo)adjuvant physicians’ choice • OS therapy • 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. 13
Robust Global Supply-Chain In Place for Sacituzumab Govitecan – Committed to Capacity and Scale Expansion 1. Antibody Manufacturing 3. Conjugation, Fill, Finish (2020 onward) Morris Plains 2. Drug-Linker Pharma Services 14
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 • 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 priorities and milestones 15
Multiple Initiatives to Drive Value for Sacituzumab Govitecan Sacituzumab Govitecan 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 • 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 priorities and milestones 17
Advancing Our Three Key Sacituzumab Govitecan Programs Study Treatment Phase of Study Indication Pivotal Designation Line Study Status Advanced Post platinum- TROPHY Initiated ✓ Urothelial 2 based chemo- June 2018 U-01 therapy and CPI Cancer HR+/HER2‒ Post hormonal, Expected ✓ Metastatic TBD 3 CDK4/6 and 2 H1 2019 chemotherapies Breast Cancer Refractory NSCLC, Trop-2-Enriched Expected SCLC, HNSCC, ‒ TBD 2 Endometrial, and Basket Study H2 2019 HCC 18
Metastatic Urothelial Cancer – Targeting our 2 nd High Unmet 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 Need Indication The Unmet Need • Current therapies for metastatic disease post chemotherapy and immune checkpoint inhibitors offers low response rate, short response duration and high toxicity Market Size • ≥2 nd line mUC – U.S. ~14k patients • ≥2 nd line mUC – EU5, Japan ~18k patients Status • May obtain accelerated approval based on results of Ph 2 TROPHY U-01 trial 19
Recommend
More recommend
