Targeting and Treating Cancer

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1 Targeting and Treating Cancer Mark R. Baker CEO Jefferies Healthcare Conference June 8, 2017

2 DISCLOSURE NOTICE This presentation may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; the performance of our partners; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Progenics is providing the information in this presentation as of its date and does not undertake any obligation to update or revise it, whether as a result of new information, future events or circumstances or otherwise. Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after the date of this presentation. This presentation may not be copied, reproduced, altered or disseminated in any manner or medium without written consent of Progenics. 2

3 PROGENICS: TARGETING AND TREATING CANCER AZEDRA Near-term commercial opportunity in ultra-orphan indication Company to submit NDA by mid-2017 Prostate Cancer Theranostics Robust portfolio of imaging agents and therapeutics designed to improve detection, monitoring and treatment of prostate cancer RELISTOR Strong financial foundation driven by RELISTOR franchise 3

4 PIPELINE Preclinical Phase 1 Phase 2 Pivotal/ Phase 3 Approved ULTRA-ORPHAN THERANOSTIC AZEDRA Theranostic Pheochromocytoma REGISTRATIONAL PHASE 2 UNDER SPA PROSTATE CANCER THERANOSTICS Automated Bone Scan Index (absi) Bone Scan Index Software 1404 PSMA-targeted SPECT Imaging Agent PyL PSMA-targeted PET Imaging Agent 1095 Small Molecule Therapeutic PSMA Antibody Conjugated with Alpha Emitter Licensed to Bayer OIC Treatment RELISTOR SC Opioid-induced Constipation 4 RELISTOR Tablets Opioid-induced Constipation

5 PHEOCHROMOCYTOMA AND PARAGANGLIOMA Adrenal Glands No currently approved therapies in the U.S. Rare tumors found primarily in the adrenal glands Results in the release of excess hormones that control heart rate, metabolism and blood pressure Left untreated, tumors most often lead to death due to high blood pressure, heart failure, stroke or metastatic disease 25-30% of cases are genetic 5

6 AZEDRA: POSITIVE DATA FROM REGISTRATIONAL TRIAL Design Achieved Primary Endpoint Favorable Tumor Response Data Multi-center study under SPA agreement with FDA Patients receive 2 therapy doses, 3 months apart 68 evaluable patients 17 patients reported 50% reduction in antihypertensive medications for at least 6 months 95% confidence interval: 16.15% % 12 responders required to achieve endpoint 92.2% of patients showed partial response or stable disease based on RECIST Safety Generally well tolerated Most common TEAEs were nausea, thrombocytopenia, anemia, fatigue, leukopenia, and neutropenia, consistent with prior studies 6

7 TRIAL ACHIEVED PRIMARY ENDPOINT Met the primary endpoint evaluating the proportion of patients who achieved a 50% reduction of all antihypertensive medication for at least six months. Under the study protocol, the primary endpoint is achieved if the lower limit of the two-sided 95% confidence interval is >10% 12 patients required to achieve endpoint Responders (%) Lower bound of Confidence Interval Upper bound of Confidence Interval Overall (n=68) 17 (25.00%) 16.15% 36.52% By Number of Doses: Two Doses (n=50) 16 (32.00%) 20.70% 45.87% One Dose (n=18) 1 (5.56%) 0.0% 27.65% 7

8 FAVORABLE TUMOR RESPONSE RATES Key secondary endpoint: the proportion of patients with overall tumor response as measured by RECIST 92.2% of evaluable patients (59/64) who received at least one AZEDRA therapeutic dose achieved partial response or stable disease Overall Tumor Response Assessment per RECIST Criteria Best confirmed response after first therapeutic dose (target and non-target lesions) Complete Response Partial Response Stable Disease Progressive Disease Unable to Evaluate Overall (n=64*) 0% 23.4% 68.8% 4.7% 3.1% 2 doses (n=50) 0% 30.0% 68.0% 2.0% 0% 1 dose (n=14 ) 0% 0% 71.4% 14.3% 14.3% * Four patients did not have follow-up scans 8

9 AZEDRA US Filing Strategy Multiple FDA Designations Rolling NDA Submission Expect Expedited Review Breakthrough Therapy Designation Fast Track Status Orphan Drug Status Non-clinical sections already submitted Expect to complete submission by mid-2017 Expect the NDA will support full approval 9

10 AZEDRA Plan to Commercialize Independently Targeted Market U.S. market reachable with a small specialty salesforce targeting major centers where these rare tumors are treated Established Relationships Majority of patients are treated at centers in U.S., many of which are sites that are participating in our registrational trial Building the Commercial Infrastructure Hired a head of commercial to develop the launch strategy; identified a U.S. based commercial manufacturer 10

11 ADDRESSING PROSTATE CANCER WITH A NOVEL PORTFOLIO OF PSMA TARGETED DIAGNOSTICS AND THERAPEUTICS 1 in 7 men will be diagnosed with prostate cancer during his lifetime 2.9M American men living with prostate cancer 1404 PyL TM PSMA Antibody 1095 Conjugated with Bone Scan BSI Alpha Emitter More sensitive in detecting cancer vs. MRI in Phase 2; currently enrolling Phase 3 study Potential to detect minimal levels of cancer, sites of relapse; currently enrolling Phase 2/3 study Potent activity in advanced cancer, First patient dosed in Phase 1 at MSK Licensed to Bayer Quantifies tumor burden of the skeleton and calculates the Bone Scan Index *Zerocancer.org

12 PSMA HAS LONG BEEN CONSIDERED AMONG THE BEST ONCOLOGY TARGETS PSMA is an attractive molecular target for radionuclide imaging and therapy of prostate cancer: Prostate cancer: Cell-surface expression of PSMA Mainly expressed in the prostate Highly expressed at all stages of the disease Upregulated in androgen-insensitive or metastatic disease Expressed on the cell surface as an integral membrane protein, and not released into the circulation Internalized after compound binding by receptormediated endocytosis Normal 12

13 1404 (SPECT/CT) PyL (PET/CT) MULTIPLE POTENTIAL USES FOR PSMA-TARGETED IMAGING AGENTS Stage in Rx Path Initial Diagnosis After Elevated PSA Rationale for Imaging Agent Localize lesions for targeting biopsy; avoid over/under diagnosis associated with biopsy Active Surveillance Initial diagnosis low risk cancer Lower morbidity than biopsy and higher specificity than PSA Primary Staging Treatment Monitoring and Planning Detecting Metastatic Disease PSMA identifies lymph node and visceral lesions in addition to bone metastases Improve accuracy of surgery and radical radiotherapy; open curative window for treatment of metastases Images lesions that are not detected by current technologies 13

14 1404 PSMA-TARGETED IMAGING AGENT SPECT radiopharmaceutical product candidate targeting PSMA In Phase 3 with interim results completed 4Q 2016 Positive Phase 2 data: higher detection rate vs. MRI Detected prostate cancer in the prostate gland with a high degree of sensitivity (94%) 1404 readers detected more prostate cancer in the prostate gland (94%) than MRI (86%) Potential to transform clinical practice with improved detection & monitoring Initial application: enabling Active Surveillance SPECT/CT SPECT/CT scan scan showing showing primary primary prostate prostate cancer cancer 14

15 Half of all men with newly diagnosed cancer have low risk tumors 40-50% of eligible men are now choosing Active Surveillance 1404 has the potential to enable Active Surveillance 15

16 LIMITATIONS OF ACTIVE SURVEILLANCE USING CURRENT APPROACHES Biopsy: Has high false negative rate Positive biopsies may miss higher grade disease thereby under-diagnosing Risk of infections and related complication Repeat biopsy generally required for active surveillance today: PSA kinetics and other measures may not be reliable in determining progression of disease Increased risk of impotence due to repeated biopsies Although more men are now participating in active surveillance, more than half still avoid active surveillance and seek treatment because of anxiety regarding the possible progression or metastasizing of their disease AUA Prostate Cancer Guidelines, NCCN Prostate Cancer Guidelines, Klotz et al. J Clin Oncol, EUA Prostate Cancer Guudelines, 2014.

17 DETECTING PROSTATE CANCER IN THE GLAND - MRI Gleason 4+5 Lesion Prostate 17

18 DETECTING PROSTATE CANCER IN THE GLAND 1404 SPECT/CT Histopathology 18

19 1404: PHASE 2 RESULTS T:B quantitative and semi-quantitative methods of assessing gland/lobe uptake show highly significant correlation with Gleason score (p<0.0001) Uptake of 1404 in the prostate gland is significantly lower in treated patients (p<0.0001) 19

20 1404 PHASE 3 STUDY DESIGN Patient Population N Primary Endpoint Secondary Endpoint Biopsy confirmed low-grade prostate cancer who are candidates for active surveillance ~450 evaluable patients Trial proceeding following interim analysis conducted in December In addition to patients electing to undergo radical prostatectomy, protocol amendment permits patients with low to very low grade prostate cancer to participate without having to undergo a radical prostatectomy. Specificity of 1404 to identify patients without clinically significant prostate cancer Sensitivity of 1404 to identify patients with clinically significant prostate cancer Safety and tolerability; Location of disease 1404 Study Overview: Biopsy Confirmed Gleason Score Dosing SPECT/ CT Imaging Prostatectomy or biopsy Histopathology 20

21 PyL: PET/CT IMAGING AGENT In-licensed from Johns Hopkins University PSMA Targeting Enables visualization of both bone and soft tissue metastases Highly specific to prostate cancer cells, not confounded by degenerative or inflammatory conditions Very high standardized uptake values (SUV) even in small lesions Identified more lesions than conventional imaging Could detect lesions as small as 3mm PyL Research Access Program underway >200 patients scanned to date 21

22 PyL PHASE 2/3 STUDY UNDERWAY Patient Population Subjects with recurrent and/or metastatic prostate cancer N Approximately 300, with ~10 sites in the U.S. and Canada Primary Endpoint Secondary Endpoint To assess diagnostic performance of PyL PET/CT imaging to detect prostate cancer in patients with recurrent and/or metastatic disease. Safety and tolerability; detection rate; pharmacokinetics parameters PyL Study Overview: High risk local and/or metastatic prostate cancer 18 F-PyL Dosing PET/ CT Imaging Prostatectomy and/or lymph nodes/ metastatic lesions dissection Histopathology of prostate and/or lymph nodes/ metastatic lesions 22

23 % CHANGE IN PSA 1095: PSMA TARGETED SMALL MOLECULE THERANOSTIC FOR PROSTATE Targeted small molecule radiotherapeutic that selectively binds to PSMA 100 * Best PSA Response in 25 patients Markedly reduced PSA levels in a heavily pretreated group of 25 evaluable patients, and reduced bone pain in German compassionate use setting in advanced prostate cancer 0 Primary study site for Phase 1: Memorial Sloan Kettering, the Coordinating Center for the Prostate Cancer Clinical Trials Consortium (PCCTC) First patient dosed March PATIENT NUMBER Zechmann et al. Eur J Nucl Med Mol Imaging,

24 LEVERAGING OUR PSMA ANTIBODY TECHNOLOGY April 2016 Granted Bayer worldwide rights to develop and commercialize products combining our PSMA Antibody Technology exclusively with Bayer s alpha-emitting radionuclides Upfront payment of $4M million Up to an additional $49M in potential clinical and regulatory development milestones Program moving forward; 2 pre-clinical milestones met in 2016 Potential net sales milestone payments up to an aggregate total of $130M Single digit royalties on net sales 24

25 EXINI Located in Lund, Sweden Capabilities Sophisticated software that assists physicians and patients in visualizing, understanding, targeting and treating cancer Successful development and commercialization of software products based on medical image analysis and machine learning Relationships with key European partners, clinicians, and researchers to support late-stage pipeline EXINI Bone BSI Quantifies tumor burden of the skeleton and calculates the Bone Scan Index BSI outcome not affected by human reader variability Reduced turnaround time Observer-independent FDA 510(k) clearance and CE-marked 25

26 $50 Million RELISTOR Non-Dilutive Royalty-Backed Financing PAMORA for treatment of Opioid- Induced Constipation (OIC) Marketed by Valeant RELISTOR Tablets launched in the U.S. on September 6, 2016 SC formulation approved in U.S. and Europe Royalty-backed agreement with Healthcare Royalty Partners $50M of non-recourse loan proceeds received November 2016 Progenics retains long-term upside potential, including rights to the to sales milestones totaling up to $200M, including $10M on first $100M in sales 26

27 2017: ADVANCING TOWARD KEY CATALYSTS AZEDRA Complete NDA submission mid-2017 Prepare for potential U.S. commercialization 1404 Complete enrollment in Phase 3 trial PyL Advance Phase 2/3 trial 1095 Advance Phase 1 trial Strong financial position to advance portfolio and launch AZEDRA Ended 1Q2017 with $126.3M in cash 27

28 Targeting and Treating Cancer Mark R. Baker CEO Jefferies Healthcare Conference June 8, 2017

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