Patient-Centric Science-Based Performance-Driven

Transcription

1 Patient-Centric Science-Based Performance-Driven Cowen & Co. 38 th Annual Health Care Conference Michael Pehl, President and Chief Executive Officer March 12, 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 Strategic Plan to Unlock Potential of ADC Platform 2018 Commercialize sacituzumab govitecan in U.S. with 3 rd line+ metastatic triplenegative breast cancer (mtnbc) as first indication Expand sacituzumab govitecan in multiple metastatic breast cancer patient segments and in advanced urothelial cancer (UC) 2. Substantiate early signals in hard-to-treat solid cancers (e.g. advanced prostate, head-and-neck, and ovarian cancers) Beyond Continue to execute sacituzumab govitecan lifecycle plan (monotherapy and combinations) 2. Labetuzumab govitecan (IMMU-130) and IMMU-140 manufacturing, positioning, and development plan 4

5 Key 2018 Business Objectives Establish sacituzumab govitecan as new standard of care in later-line mtnbc 1. Submit BLA for accelerated approval in 3rd-line mtnbc by end of May Complete CMC preparations before FDA review Pre-approval inspection activities continue Commercial drug manufacturing continues 3. Build a best-in-class commercial organization and a blockbuster brand in oncology Full launch readiness by Q Continue confirmatory ASCENT study in mtnbc First patient dosed in November 2017 in U.S. European sites continue to be activated, first patients initiated 5. Define registration and commercialization strategy in Europe Need to balance speed to market vs reimbursement Build foundational therapy in TNBC and advanced UC across treatment lines 1. TNBC Conduct monotherapy and combination studies in 1 st - and 2 nd -line TNBC Pursue strategic clinical partnership for combination studies with PARP- and checkpoint-inhibitors in 1 st -line setting Explore combinations with platinum and taxanes 2. Advanced UC Define exact 3 rd- -line target patient population with input from FDA Enroll additional patients in agreed upon patient segment Pursue Breakthrough Therapy Designation and accelerated approval Initiate earlier-line combination studies with PARP- and checkpoint-inhibitors BLA = biologics license application, CMC = chemistry, manufacturing, and controls, PARPi = poly (adenosine diphosphate ) ribose polymerase inhibitor 5

6 Rationale for Combining Targeted Topoisomerase-I Inhibition (Sacituzumab Govitecan) & PARPi in TNBC 1. Synthetic lethality A drug exploits a mutation that enhances its potency in cells having this mutation more than cells lacking the defect BRCA1/2 mutations in breast cancer, including TNBC, affect repair of dsdna breaks PARPi blocks repair of ssdna breaks and exacerbates defects caused by BRCA1/2 mutations 2. SN-38, a topoisomerase-i inhibitor, induces ssdna breaks; PARPi blocks repair of ssdna breaks 3. Combining targeted topoisomerase-i inhibition (sacituzumab govitecan) and PARPi could be synergistic in TNBC patients without BRCA1/2 mutations 6 BRCA 1/2 = BReast CAncer genes 1 and 2, dsdna and ssdna = double-stranded and single-stranded DNA

7 T u m o r V o lu m e s ± S D (c m 3 ) T u m o r V o lu m e s ± S D (c m 3 ) Preclinical Data Support Evaluation of Targeted Topoisomerase-I Inhibition (Sacituzumab Govitecan)/PARPi Combination in TNBC HCC1806 (BRCA1/2 mutated) MDA-MB-468 (BRCA1/2 wild type, PTEN mutation) H C C M D A - M B S a l i n e S a l i n e O la p a r ib ( 5 0 m g /k g ) O la p a r ib ( 5 0 m g /k g ) C o n t r o l A D C ( g ) O la p a r ib p lu s C o n t r o l A D C IM M U ( g ) C o n t r o l A D C ( g ) O la p a r ib p lu s C o n t r o l A D C IM M U ( g ) O la p a r i b p lu s IM M U O la p a r i b p lu s IM M U A D C A d m in is tra tio n A D C A d m in is tra tio n T im e P o s t-t u m o r T ra n s p la n t (d a y s ) O la p a rib A d m in is tra tio n T im e P o s t-t u m o r T ra n s p la n t (d a y s ) O la p a rib A d m in is tra tio n In in vivo TNBC models, targeted topoisomerase-i inhibition (sacituzumab govitecan)/parpi combination achieved synergistic growth inhibition in both BRCA1/2 mutated and wild-type cells PTEN = Phosphatase and tensin homolog. Source of data: Cardillo TM et. al. Clin. Cancer Res. 2017; 23(13):

8 A Relatively High Recurrence Rate from Early-Stage Disease and High Treatment Rates in 3 rd Line Create a Sizeable Opportunity at Launch 2017 TNBC Incidence in U.S k Patients Stage I Stage II Stage III Resection +/- Adjuvant Chemo Resection +/- Neoadjuvant Chemo +/- Adjuvant Chemo Resection +/- Neoadjuvant Chemo +/- Adjuvant Chemo 30-40% Treatment Rate 1 st Line % 7-10% Stage IV 1L Chemotherapy 10-11k Patients 2 nd Line 85-90% 2L Chemotherapy 9-10k Patients Target population for the initial indication 3rd Line 80-85% 3L Chemotherapy 8-9k Patients 8 Source: Immunomedics Primary Market Research 2018, Health Advances interviews and analysis, UpToDate, NCCN.

9 Drug Supply Building for Commercial Launch /2018 May 2018 Q Q Process Development Process Validation BLA Submission Pre-Approval Inspection Commercial Launch 9

10 Drug Supply Building for the Future Multiple sacituzumab govitecan indications 2. Geographic expansion Launch process 2nd sourcing and scale up Process improvement and intellectual property enhancement 3. Margin improvement 10

11 Current SOC* for mtnbc Provides Limited Benefit Drug Phase N Population ORR (%) PFS (mos) OS (mos) 1st line treatment Carboplatin st line Docetaxol st line Cisplatin/ Carboplatin st line (80.2%) >1st line treatment Ixabepilone 3 2 (pooled analysis) 60 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

12 Single Arm, Open-Label Study Patient Demographics N = 110 Female/Male, n 109/1 Median age, years (range) 55 (31-81) Race White Black Asian Other Not specified ECOG performance status % 7% 4% 4% 10% 30% 70% Median time from metastatic disease to study entry, years (range) 1.5 ( ) >3 rd line for metastatic disease 3 rd line* >4 th line 100% 41% 59% Prior chemotherapy drugs** Taxanes Anthracyclines Cyclophosphamide Platinum agents Gemcitabine Fluoropyrimidine agents Eribulin Vinorelbine Prior checkpoint inhibitors Sites of metastatic disease at study entry*** Lung/mediastinum Liver Bone Chest wall N = % 86% 85% 75% 57% 51% 45% 15% 17% 58% 46% 45% 24% 12 * Two patients who progressed within 12 months of (neo)adjuvant therapy only received one line in the metastatic setting; ** Used in >10% patients; *** Metastatic sites reported in >20% patients

13 Compelling Results Presented at 2017 SABCS 1. Clinical benefit rate (CR+PR+SD 6 months) = 45% (50/110) 2. 74% (75/102) of patients with at least one CT response assessment had reduction of target lesions (sum of diameters) patients had 1 scheduled CT response assessment, 8 patients withdrew prior to assessment (4 PD, 4 MRI brain metastasis) 13 * Patients with at least 20% tumor reduction (n = 56) were reviewed; ** Confirmed objective response rate per RECIST; *** Waterfall is based on local assessment.

14 Response Onset and Durability (n=37) Local BICR * Median duration of response, months (95% CI) 7.6 (4.8, 11.3) 9.1 (4.1, 14.3) Complete response 1. Median time to onset of response: 2.0 months (range: ) 2. 9 long-term responders were progression free for >1 year from start of treatment (4 responders >2 years) patients were still receiving sacituzumab govitecan at time of data cutoff, June 30, 2017 Partial response Continuing treatment as of June 30, 2017 cutoff Left study with PR (censored) Onset of objective response Months from start of sacituzumab govitecan * Patients with at least 20% tumor reduction (n = 56) were reviewed. 14

15 Time on Treatment for All Patients (N = 110) 15 Last prior time on treatment calculated as last dose date first dose date. Sacituzumab govitecan time on treatment calculated as (date off study or data cut off date of June ) first dose date. If more than 1 agent is given in the last prior regimen, the time of the last prior treatment is taken as the longest time for any agent used

16 Response to Sacituzumab Govitecan in Subgroups* ORR, % (n/n) Overall 34% (37/110) Age <55 55 Onset of metastatic disease 1.5 years 1.5 years Prior regimens for metastatic disease 3 rd line 4 th line 37% (20/54) 30% (17/56) 29% (16/55) 38% (21/55) 36% (16/45) 32% (21/65) Visceral involvement at study entry Yes No Trop-2 IHC (n = 62) 0-1 (weak, absent) 2-3 (moderate, strong) No Trop-2 IHC available Prior checkpoint inhibitors ORR, % (n/n) 30% (26/88) 50% (11/22) 0% (0/5) 40% (23/57) 29% (14/48) 47% (9/19) * Based on local assessment 16

17 Progression-free Survival (%) Overall Survival (%) Progression-free and Overall Survival* 100 Progression-free survival 100 Overall survival Median (95% CI): 5.5 months (4.8, 6.6) Median (95% CI): 12.7 months (10.8, 13.6) 80 85/110 (77%) number of events 80 71/110 (64%) deaths reported Months Number at risk Months Number at risk * Based on local assessment

18 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 2. Two patients (1.8%) discontinued due to adverse events (grade 3 transient infusion reaction/grade 2 fatigue 3. There were no treatment-related deaths

19 ASCENT Phase 3 Study Overview Metastatic TNBC Refractory/relapsed after 2 prior SOC chemotherapies for advanced disease OR 1 therapy for patients who progressed within 12 months of completion of (neo)adjuvant therapy N = 328 Stratification Factors No. of prior therapies Geographic region Presence/absence of known brain metastasis Sacituzumab govitecan (IMMU-132) 10 mg/kg IV, days 1 and 8 every 21 days Treatment of physician choice Capecitabine Eribulin Gemcitabine Vinorelbine Continue treatment until progression Primary Endpoint PFS (Blinded Independent Central Read) Secondary Endpoint Overall Survival 1. First patient dosed in November 2017 in U.S. 2. European sites continue to be activated, first patients initiated 19

20 Sacituzumab Govitecan Patent Protection Through issued U.S. and 22 foreign patents Covering composition of matter, synthesis and uses 2. IP coverage through 2033 (plus potential term extension up to 5 years) protecting Methods of treating cancer over broad range of dosages Methods of production, and certain combination therapies Composition of matter patents expire in 2023 in the U.S., and in 2029 in Europe 3. Patent applications prosecuted in all major countries Patents issued in Australia, Canada, China, Europe, Israel, Japan, Mexico and South Korea 20

21 $250 Million Agreements with Royalty Pharma 1. Terms of Royalty Funding & Stock Purchase Agreements include Royalty Pharma acquiring royalty rights on global net sales of sacituzumab govitecan across all indications a) Royalty Rate starts at 4.15% and tiers down to 1.75% based on annual sales exceeding $6 billion Immunomedics receiving a) $175 million upfront cash payment b) $75 million in equity investment at $17.15 per share, a >15% premium over a 15-day trailing average closing price 2. Mutually beneficial transaction further advances sacituzumab govitecan Transaction will provide sufficient cash to fund operations into 2020

22 Sufficient Cash Runway to Pursue Strategic Priorities Cash balance as of 12/31/2017 $140 Million Gross cash proceed from Royalty Pharma* $250 Million Pro forma cash balance as of 12/31/2017 $390 Million Debt (convertible senior notes) $20 Million Pro forma shares outstanding (fully diluted) 165 (191) Million Data as of December 31, 2017, * Royalty Pharma agreements on January 7,