IMMUNOMEDICS, INC. February Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases

Transcription

1 IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases February 2016

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 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 Highlights Multiple late-stage opportunities in underserved markets Cancer programs focused on unmet need in difficult-to-treat tumors Two Phase 3 candidates and two Phase 2 candidates Next 18 months could be transformational Phase 3 pivotal trial of IMMU-132 in triple-negative breast cancer planned in calendar year 2016 Interim Phase 2 results in major metastatic solid cancers very encouraging Valuable asset for partnering 90 Y-clivatuzumab tetraxetan Phase 3 trial in pancreatic cancer expected to complete patient enrollment in calendar year 2016 Potentially first self-commercialized product, if approved Several additional agents identified to continue pipeline progress 3

4 Broad Pipeline of Antibody-Based Therapies Research/Preclinical Phase 1 Phase 2 Phase 3 90 Y-clivatuzumab tetraxetan 3 + -line advanced pancreatic cancer Complete Phase 3 enrollment in 2016 Epratuzumab (humanized anti-cd22) Pediatric acute lymphoblastic leukemia* Antibody-drug conjugates IMMU-132: anti-trop-2-sn-38 for metastatic solid tumors IMMU-130: anti-ceacam5-sn-38 for mcrc Other product candidates Veltuzumab (anti-cd20) for cancer and autoimmune diseases Milatuzumab (anti-cd74) for autoimmune diseases IMMU-114 (anti-hla-dr) for hematologic malignancies 4 * The International clinical trial on childhood relapsed acute lymphoblastic leukemia (IntReALL) is funded by the European Commission.

5 ADC Products - Targeting Difficult-to-Treat Tumors Potential characteristics of difficult-to-treat tumors Not responsive to prior therapies Protected by surrounding layer of connective tissue Often become metastatic Components of IMMU s antibody-drug conjugation platform (ADC) Highly specific MAb that is targeted to cancer cells Specially designed payload drug that delivers a concentrated dose to the tumor A linker designed to release the payload at the tumor site Immunomedics Next Generation ADC Technology Platform 1. Reduced toxicity 2. Greater dose of drug to tumor 3. Opportunity for long-term, repeated treatments 5

6 What Makes IMMU s ADCs Different? Unique approach to ADC therapeutics for cancer Highly cancer-specific antibodies based on 30 years of experience Utilize moderately potent payloads: increased therapeutic index Proprietary linker for rapid payload release at or inside tumor High drug-to-antibody ratio (~7.6:1) SN-38 payload Active metabolite with more potency than its parent compound, irinotecan (a commonly used chemotherapy) ADCs unique chemistry avoids low solubility and selectively delivers SN-38 to the tumor Two ADCs completed Phase 2: IMMU-132 and IMMU-130 6

7 IMMU-132: Increased Payload Potency Up to 135x Higher Delivery of SN-38 SN-38 (ng/g) IMMU-132-treated animals SN-38 (ng/g) Irinotecan-treated animals Irinotecan-treated AUC last (µg/g h) IMMU-132-treated IMMU-132 delivers up to 135-fold more SN-38 to Capan-1 xenografts than irinotecan Keep in mind these facts: Mice convert irinotecan to SN-38 more efficiently than humans. Mice were given 22-fold more SN-38 equivalents with the irinotecan dose than the IMMU-132 dose, yet IMMU-132 delivers 135-fold more SN Presented at World ADC San Diego 2014

8 IMMU-132 Targets a Variety of Solid Tumors 8 Mechanism of action Binds TROP-2, which is highly expressed on many epithelial cancer cells IMMU-132 is internalized into the tumor cells before SN-38 is released Breakthrough Therapy designation from FDA in metastatic triplenegative breast cancer U.S. Fast Track designation in triple-negative breast, non-smallcell and small-cell lung cancers U.S. Orphan Drug status in small-cell lung and pancreatic cancers Encouraging results from Phase 1/2 reported Mild and manageable toxicity at recommended doses Numerous objective responses or long-term disease stabilization in heavily pretreated patients; including patients previously treated with topoisomerase inhibitors Multiple treatment cycles administered

9 IMMU-132: Summary Efficacy (Patients with at least one post-treatment response evaluation) Meaningful responses in patients having multiple prior therapies dosed at 10 mg/kg, Phase 1 / 2 clinical trials Cancer Type 1 Number % Disease of Patients % ORR 2 Control 3 Median PFS (months) Maturity TNBC % 72% % NSCLC 29 28% 72% % SCLC 25 24% 56% % UC 11 55% 73% N/A N/A 1 TNBC = triple-negative breast cancer, NSCLC = non-small cell lung cancer, SCLC = small cell lung cancer, UC = urothelial cancer. 2 Objective response rate (%ORR) = (complete response + partial response)/number of patients. 3 % Disease Control = (complete response + partial response + stable disease)/number of patients. 4 Patients with 2 or more prior lines of therapy that included a taxane. 9 Presented at 2015 World ADC Summit in San Diego, CA, results in TNBC updated at 2015 SABCS in San Antonio, TX.

10 IMMU-132: Best Response from TNBC Patients 58 assessable (10 mg/kg), 11 continuing treatments Objective response (CR + PR) = 31% Disease control (CR + PR + SD) = 72% Median prior chemotherapies = 5 (range, 2 12) (CR) = 2 (PR) = 16 (SD) = 24 (PD) = PD patients with progression of non-target lesions or new lesion not shown 60 patients with 2 or more prior lines of therapy that included a taxane enrolled 2 excluded because <3 doses given. 10 Presented at 2015 SABCS in San Antonio, TX

11 IMMU-132: Best Response from NSCLC Patients 29 assessable (8 or 10 mg/kg) Objective response (CR + PR) = 28% Disease control (CR + PR + SD) = 72% 11 Best response (% change in target lesions from baseline) Median prior therapies = 3 (range, 1 7) 3 PD patients with progression of non-target lesions or new lesion not shown patients enrolled; 3 have not had their first assessment; 1 excluded because <3 doses given. Presented at 2015 World ADC Summit in San Diego, CA (CR) = 0 (PR) = 8 (SD) = 13 (PD) = 8

12 IMMU-132: Best Response from SCLC Patients 25 assessable (post platinum, 8 or 10 mg/kg) Objective response (CR + PR) = 24% Disease control (CR + PR + SD) = 56% Median prior therapies = 3 (range, 1 5) (CR) = 0 (PR) = 6 (SD) = 8 (PD) = PD patients with new lesion not shown patients enrolled; 2 excluded because <3 doses given. Presented at 2015 World ADC Summit in San Diego, CA

13 IMMU-132: Best Response from UC Patients 11 assessable Objective response (CR + PR) = 55% Disease control (CR + PR + SD) = 73% Best response (% change in target lesions from baseline) Median prior therapies = 2 (range, 1 4) 1 PD patient with new lesion not shown (CR) = 0 (PR) = 6 (SD) = 2 (PD) = patients enrolled; 3 have not had their first assessment; 1 excluded because <3 doses given. 13 Presented at 2015 World ADC Summit in San Diego, CA

14 IMMU-132: Mild, Predictable and Manageable Toxicity Interim adverse events (Grades 3 and 4): Starting dose of 10 mg/kg (N=119) Grade 3 Grade 4 Neutropenia 13 (11%) 7 (6%) Anemia 4 (3%) 1 (0.8%) Fatigue 5 (4%) 0 Diarrhea 8 (7%) 0 Febrile neutropenia 3 (3%) 2 (2%) Note: Grade 2 Alopecia N = 21 (18%) Additional likely-related Grade 3 events included: Asthenia, hypokalemia, lymphopenia, staphylococcal bacteremia, thrombocytopenia, and vomiting 1 pt each Camptosar (irinotecan) US Prescribing Information (USPI) boxed warnings Early and late forms of diarrhea can occur (Grades 3 & 4: 38%) Severe myelosuppression may occur (Neutropenia: Grades 3 & 4: 31%) No anti-antibody responses detected to-date, even after repeated dosing Minimal dose delays; 15%-16% of patients required dose reductions 14 Data on file as of October 12, 2015, Immunomedics, Inc.

15 IMMU-130 in Metastatic Colorectal Cancer Mechanism of action Binds to CEACAM5 on colorectal and other tumor cells SN-38 is released locally from IMMU-130 for diffusion into tumor cells Promising activity in metastatic CRC previously treated with irinotecan therapy Acceptable safety profile in heavily pretreated patients Dose-limiting neutropenia (G3 and G4 = 10%) Minimal diarrhea (G3 = 3%) Repeated doses given over months without interfering host antibodies 15 Presented at 2015 Annual Meeting of the American Society of Clinical Oncology in Chicago, IL

16 IMMU-130: Best Response Results Dose Group (mg/kg) Number of Patients PR SD PD 4 (twice weekly) (twice weekly) (once a week) (once a week) Presented at 2015 Annual Meeting of the American Society of Clinical Oncology in Chicago, IL

17 90 Y-Clivatuzumab Tetraxetan: Phase 3 for PC Labeled with 90 Y for potential first-in-class therapy Designed to selectively deliver radiation to pancreatic tumor tissue Under investigation in combination with low dose gemcitabine for enhanced activity Orphan Drug designation in the United States and EU Fast Track status with FDA Highly specific antibody targeting mucin antigen Does not bind to normal pancreas tissue or pancreatitis while reactive to ~85% of pancreatic cancers Global randomized, double-blind, Phase 3 study; completion of enrollment expected in 2016 Product patent-protected 17

18 Phase 1b: Initial Experience in Refractory PC Open label study in patients with metastatic pancreatic cancer who had received two or more prior therapies Study regimen: 6.5 mci/m 2 90 Y-clivatuzumab tetraxetan qw x3 +/- low dose gemcitabine (200 mg/m 2 qw x4) Encouraging overall survival trends with minimal toxicity of the combination therapy 16 Patients Alive at 3, 6, 9 and 12 Months 14 Number of Patients Y-clivatuzumab tetraxetan + gemcitabine (Arm A) 90 Y-clivatuzumab tetraxetan monotherapy (Arm B) 3 Months 6 Months 9 Months 12 Months N 3 Months 6 Months 9 Months 12 Months Arm A (48%) 10 (34%) 6 (21%) 3 (10%) Arm B (34%) 3 (10%) 1 (3%) 0 (0%) 18 Final data presented at 2014 ASCO

19 90 Y-Clivatuzumab Tetraxetan P3 Design (PANCRIT-1) Double-blind, placebo-controlled, registration study in advanced pancreatic cancer patients who had received two or more prior therapies Prior therapy must include gemcitabine Primary endpoint: Overall survival N = 440 Randomization Arm 1: 6.5mCi/m 2 90 Y-clivatuzumab tetraxetan qw x mg/m 2 gemcitabine qw x4 per 7-week cycle (n=293) Arm 2: Placebo qw x mg/m 2 gemcitabine qw x4 per 7-week cycle (n=147) Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 (max) 19

20 Financial Highlights (As of December 31, 2015) Basic shares outstanding 95 million Market capitalization $291 million Debt (convertible senior notes) $100 million Cash, cash equivalents and marketable securities $76 million* Forecast FY 2016 annual cash burn (6/30/16) $52-54 million * Does not include the $1.9 million cash proceeds received in January 2016 from a second sale of the Company s New Jersey State net operating losses and research and development tax credits. 20

21 Meaningful Anticipated Upcoming Events Program Event Expected Timing IMMU-132 / IMMU-130 Updated Phase 2 results presentations 1H 2016 IMMU-132 IMMU Y-clivatuzumab tetraxetan Complete Phase 3 pivotal trial preparation in metastatic triple-negative breast cancer Complete Phase 3 trial design in metastatic colorectal cancer Complete Phase 3 enrollment in 3 + -line pancreatic cancer 2H