Changing Lives. Daniel Junius, President and CEO June 3, Nasdaq: IMGN

Transcription

1 Changing Lives Daniel Junius, President and CEO June 3, 215 Nasdaq: IMGN

2 Forward-Looking Statements This presentation includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the occurrence, timing and outcome of potential pre-clinical, clinical and regulatory events related to the Company's and its collaboration partners' product programs; the presentation of preclinical and clinical data on the Company s and its collaboration partners product candidates; and financial guidance for the Company s 215 fiscal year. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of Various factors could cause ImmunoGen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of these slides. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of ImmunoGen's and its collaboration partners' research and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense and results of preclinical studies, clinical trials and regulatory processes; ImmunoGen's ability to financially support its product programs; the Company s dependence on its collaborative partners; industry merger and acquisition activity; and other factors more fully described in ImmunoGen's Annual Report on Form 1-K for the fiscal year ended June 3, 214 and other reports filed with the Securities and Exchange Commission. 2

3 ImmunoGen: Transformational Year Clinical proof of concept for first wholly owned product candidate mirvetuximab soravtansine (IMGN853) at ASCO Advancing into later-stage testing High potential pipeline wholly owned, with partners Expanding technology portfolio Well funded 3

4 ImmunoGen: Helping Patients, Building Value through ADC Leadership NOW FRONT AND CENTER: IMMUNOGEN PRODUCT CANDIDATES Mirvetuximab soravtansine: Data at ASCO supporting aggressive development Additional high potential product programs Leading companies licensing access to ImmunoGen ADC technology Antibody-Drug Conjugate (ADC) Partner progress with product candidates using ImmunoGen technology 4

5 Mirvetuximab Soravtansine First and only ADC to target folate receptor α (FRα) FRα highly expressed on ovarian cancers, other solid tumors (e.g., endometrial, lung) ADC a validated approach for solid tumors (Kadcyla) Lead indication platinum-resistant ovarian cancer 5

6 Ovarian Cancer ~21,3 diagnoses/14,2 deaths per year in US Treatment Initially: platinum-based (e.g. carboplatin + taxane +/- other agents) 2 nd line/later limited single-agent activity: Agent Response rate* Doxil 15-2% Paclitaxel 15-2% Topotecan 21% CHALLENGING TOLERABILITY PROFILES Doxil: grade 3/4 hand and foot syndrome 24% Paclitaxel: alopecia 87%; neutropenia, leukopenia both 9% *From prescribing information and published clinical data 6

7 Mirvetuximab Soravtansine ASCO patients Ph 1 expansion cohort All with platinum-resistant ovarian cancer All with FRα-positive disease - 8% of the patients screened met expression criteria All had prior platinum, taxane - Median prior regimens = 4 17 efficacy evaluable (5 not yet reached first assessment) Received recommended phase 2 dose (RP2D) from dose-finding phase 6. mg/kg 1x/3 weeks 7

8 Mirvetuximab Soravtansine ASCO 215 NOTABLE SINGLE AGENT ACTIVITY MANAGEABLE SIDE EFFECT PROFILE 53% (9/17) objective response rate 6 of 9 responses ongoing 5 for weeks Majority of adverse events grade 1 or 2 Most common treatmentemergent: diarrhea, blurred vision, nausea, vomiting, fatigue, abdominal pain Maximum Percent Change from Baseline (%) ASCO 215 Abstract #5518 8

9 Mirvetuximab Soravtansine ASCO 215 Most Patients Still on Study ASCO 215 Abstract #5518 9

10 Mirvetuximab Soravtansine Two-Pronged Development Strategy Advance rapidly Platinum-resistant ovarian cancer as single agent Phase 1 expansion cohort Phase 2 With potential to support accelerated registration program Start 4Q 215 Expand potential uses Earlier-stage ovarian cancer Assessment in combination Start 4Q 215 Other FRαpositive cancers Endometrial Phase 1 expansion Underway Recently established research collaboration with NCCN 1

11 Rich Pipeline Wholly Owned, with Partners Wholly Owned Product Candidates Partner Programs Mirvetuximab soravtansine IMGN529 - Advancing, expanding clinical program - Data at ASH 214 Coltuximab ravtansine - Recently regained - Next steps being developed IMGN779 - On track for IND 2H215 1 compounds, including Kadcyla, in clinic today through partners - Multiple events, data presentations expected in next 12 months - Indatuximab ravtansine (BT-62) ImmunoGen US opt-in rights 1 additional targets licensed Our partners: - Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Roche, Sanofi, Takeda 11

12 IMGN529 PROFILE PROFILE ADC targeting CD37 for B-cell malignancies Antibody - highly active NEED Diffuse large B-cell lymphoma (DLBCL) Few options for later-stage patients ~6, deaths/year (US) Non-Hodgkin lymphoma (NHL), other B-cell malignancies Better tolerated alternatives to chemotherapy Post-transplant therapies DIFFERENTIATION Relapsed/refractory DLBCL Tolerability profile 12

13 IMGN529: Encouraging Initial Findings In dose finding Phase 1 patients with heavily pretreated NHL Updated findings at ASH 214 In relapsed/refractory DLBCL 4% (4/1) had objective response across all dose levels Benefit in 3/5 patients at highest dose level completed 1 CR, 1 PR, 1 stable disease Maximum tolerated dose not yet established Disease-specific testing to include DLBCL, CLL Preclinical w/ rituximab to be reported at Int l Conference on Malignant Lymphoma Targeting ASH for next clinical data presentation Maximum Percent Change from Baseline (%) *Tumor shrinkage with new lesion formation CR = complete response PR = partial response PR * PR PR Evaluable patients with DLBCL All dose levels CR 13

14 Coltuximab Ravtansine PROFILE ADC targeting CD19 NEED STAGE Better treatments for DLBCL and other B-cell malignancies Phase 2 data in DLBCL at ASCO 214 Product candidate recently regained by ImmunoGen NEXT STEPS Being developed 14

15 Coltuximab Ravtansine: Proof of Concept STARLYTE Ph 2 trial Single agent for previously treated DLBCL Proof-of-concept achieved per study investigators 43.9% ORR vs. 2% pre-set threshold (per protocol population) Efficacy demonstrated in hard-to-treat DLBCL patient populations Relapsed (n=26): Refractory to last treatment (n=15): Primary refractory (n=14): Benefit in hard-to-treat GCB comparable to ABC 53.8% ORR, with 5 CRs, 9 PRs 26.7% ORR, with 1 CR, 3 PRs 21.4% ORR, with 1 CR, 2 PRs Favorable tolerability profile, few grade 3/4 adverse events Any ocular events were grade 1/2, reversible and manageable ORR=objective response rate, Cheson 27 criteria 15

16 Indatuximab Ravtansine: Proof of Concept in Multiple Myeloma CD138-targeting ADC Biotest program; ImmunoGen US opt-in rights Results at ASH 214 BT-62 + lenalidamide/dexamethsone Evaluable Patients RPTD cohort 1 mg/m 2 Prior Len and Bortezomib Len refractory n % n % n % n % Total N ORR ( PR) scr CR VGPR PR MR SD PD Source: Biotest 16

17 IMGN779 ADC targeting CD33 PROFILE Acute myeloid leukemia, myelodysplastic syndrome DNA-alkylating payload NEED Limited options today STAGE Preclinical NEXT STEP IND submission 2H

18 ImmunoGen: Leading ADC Innovation For ImmunoGen product programs, partners PAYLOAD AGENTS Tubulin-acting (DM1, DM4) DNA-acting Alkylate & cross link Alkylate only TARGETING VEHICLES Purpose-optimized antibodies active, payload delivery LINKERS Cleavable +/- in cancer cell Counter multi-drug resistance Intracellular processing COMBINATION REGIMENS Current standards of care Site-specific technology Emerging new classes Alternative approaches CytomX Probodies 18

19 Deep Pipeline of Partner Programs 2 Unique Targets Earlier Stage Phase 1/2 Phase 3 Approved Kadcyla 2L metast Kadcyla 1L metast Kadcyla adjuvant Kadcyla neoadjuv Kadcyla early resid Kadcyla gastric Kadcyla NSCLC SAR65984* SAR SAR4871 Sanofi 4 BT-62 AMG 595 AMG 172 Amgen 3 Amgen 4/OBT BAY Novartis 3 Novartis 4 Novartis 5 Novartis 6 Lilly 1 Lilly 2 Lilly 3 LOP628 PCA Ph 1 starts 215 Technology access agreement *non-adc, naked antibody 19

20 Pipeline-Related Anticipated Events Wholly Owned Programs Partner Programs Mirvetuximab Soravtansine Clinical data Start pt-resist ovarian Ph 2 ASCO 4Q215 Start combo testing in ovarian 4Q215 IMGN529 Start DLBCL Ph 1 cohort Start CLL Ph 1 cohort Start combination testing Clinical data IMGN779 IND filing 3Q215 3Q215 2H215 4Q215 Coltuximab Ravtansine Communication of next steps 215 2H215 Kadcyla MARIANNE Data ASCO Regulatory discussions 215 GATSBY Readout 215 Regulatory filing (if positive) 215 Sales development 215 Other Clinical Compounds Potential for data disclosures, development events 215 Additional compounds enter clinic 215 Kadcyla events/timings are Roche expectations 2

21 Solid Financial Position to Fund Internal Pipeline $ MM FY214 Ended 6/3/214 FY215 9 months Ended 3/31/215 4/24/215 Guidance for FY215 Ending 6/3/15 Revenues $6 $73 $85 - $95 Operating expenses $131 $12 $145 - $15 Net loss ($71) ($3) ($6 - $65) Net cash used for operations ($54) ($27)* ($55 - $6) Cash/marketable securities $142 $112* $265 - $275** *Includes $2 MM upfront payment from Takeda technology access agreement **Includes approx. $194 MM net proceeds from Kadcyla royalty monetization transaction 21

22 ImmunoGen: Transformational Year Clinical proof of concept for first wholly owned product candidate mirvetuximab soravtansine (IMGN853) at ASCO Advancing into later-stage testing High potential pipeline wholly owned, with partners Expanding technology portfolio Well funded 22

23 Changing Lives Nasdaq: IMGN