GLG Pharma is Disrupting Triple Negative and HER2 Breast Cancer

Transcription

1 GLG Pharma is Disrupting Triple Negative and HER2 Breast Cancer

2 Safe Harbor Certain of the statements and the projections set forth in this presentation constitute forwardlooking statements. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words estimate, project, intend, forecast, anticipate, plan, planning, expect, believe, will, will likely, should, could, would, may or words or expressions of similar meaning. All such forward-looking statements involve risks and uncertainties, including but not limited to the factors set forth in the Risk Factors section of this presentation and to the particular risks inherent in any development stage company that has developed new products for which it has not yet demonstrated market acceptance or generated any historical sales. Prospective investors are cautioned that there also can be no assurance that the forward-looking statements included in this presentation will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by us or any other person that our objectives and plans will be achieved in any specified timeframe, if at all. Except to the extent required by applicable laws or rules, we do not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. 3/23/2016 Richard Gabriel - GLG Pharma Presentation 2

3 Company Overview Significant Accomplishments 1. STAT3 Inhibitor Technology Licensed from Moffitt Cancer Center, Tampa FL Dana Farber Cancer Institute, Boston MA 2. Ongoing Phase I/II clinical trials for Chronic Lymphocytic Leukemia 3. Received > US$4.7 million in non-dilutive funding from government agencies. Ongoing US National Cancer Institute PREVENT program US$973K ( ) NCBR Poland recently approved US$ 2.6 million grant 4. Established clinical development subsidiaries: France (US$1,500,000 cancer research funding pending); and Latin America (US$400,000 in cancer research funding pending) 5. Successfully completed early preclinical safety testing for one of our drug candidates 6. Successfully completed preclinical treatment studies in breast cancer, liver cancer, brain cancer, kidney disease and infectious disease 3/23/2016 Richard Gabriel - GLG Pharma Presentation 3

4 Summary of the Offer FDA/EMA & Rare Disease Groups & Agencies Collaborating on Rapid Approval Scenarios GLG Pharma is disrupting the $100 Billion branded oncology market 8 patents protect the IP covering combination products and diagnostic tests and several more pending Addresses Needs of Patients, Prescribers and Payers Reduced Time to Market Approval Using US FDA Fast Track and Similar EMA Strategy US FDA Rare Disease Focus Triple Negative Breast Cancer (TNBC) EMA Rare Disease Focus HER2 Breast Cancer Market Exclusivities in US and in EU for Targeted Diseases $10 Million Capital Raise Advances development of combination products for oncology purchases Launches Companion Diagnostic with Products Protects Products Position in the Markets Increased Barriers to Entry by Competitors 3/23/2016 Richard Gabriel - GLG Pharma Presentation 4

5 Market is Profitable and Growing US Anti-Cancer Market Tops $100B*, Growing at 11.2%* CAGR to 2020 Rare Disease Oncology Products to Receive Top Dollar Pricing Combination Products of Existing Oncology Drugs: GLG s Diagnostic and Inhibitors are Patented and Includes Combination Products All GLG Combination Therapies using Existing Approved Products will be used to reverse /prevent acquired resistance to anticancer drugs All GLG Combinations with Newly Approved Therapies may be patentable Well Developed Markets: Regional and International Partnering Opportunities A Strong Established Need for Alternative Treatments to Failed Drugs in Patients with TNBC and HER2 that Develop Resistance * Fierce Pharma; Tracy Staton May 6, 2014; Cancer Market Zooms to $100B, thanks to costly Targeted Therapies. Also Evaluate Pharma, 2014 Report Oncology from /23/2016 Richard Gabriel - GLG Pharma Presentation 5

6 The Big Opportunity Simple, Disruptive, Combination Treatments; Easily Understood by Patients, Care Givers and Payers FDA/EMA & Rare Disease Groups & Agencies Collaborating on Rapid Approval Scenarios Companion diagnostics help oncologists focus patient treatment- helps protect products GLG Compounds improve treatment when combined with new Immunotherapeutics: GLG Diagnostic Used for guiding combination Rx of Biological and Small Molecule Therapeutics GLG Diagnostic tests will permit Accelerated Approvals for Orphan & Rare diseases: TNBC and HER2 3/23/2016 Richard Gabriel - GLG Pharma Presentation 6

7 The Big Problem Breast cancer remains the most common cancer diagnosed in women, Still the second leading cause of cancer-related deaths 16,000 breast cancers including 17% TNBC in Poland (2,720) 230,480 US (1.7 million worldwide) estimated invasive breast cancer diagnoses in ,000 US women will relapse; ~ 20,000 with TNBC Limited treatment options available Current path to approval in early-stage disease takes too long, especially for high-risk patients with potential for cure. Unique EMA & FDA accelerated approval process Focus on triple negative (ER,PR,HER2-) and HER2+ patients High risk population with highest likelihood of pcr (pathological complete response) Most compelling data that pcr predicts survival Getting Potentially Life-Saving Drugs to High-Risk Breast Cancer Patients Faster Tatiana Prowell, M.D., Breast Cancer Scientific Lead, Division of Oncology Products 1 & Richard Pazdur, M.D., Director The Office of Hematology and Oncology Products at FDA s CDER 3/23/2016 Richard Gabriel - GLG Pharma Presentation 7

8 pcr rates with EMA & FDA approved regimens are < 55% Complete Marker-Disease Remission is Elusory even with Targeted Therapies T-DM1 approved 2013;HER2+ and HR+ Sub-Types Complicate Disease Treatment Requiring Tailored Treatments Septo/03_Abb_gross/SABCS_Mamma_04_151218_750.jpg 3/23/2016 Richard Gabriel - GLG Pharma Presentation 8

9 A Big Problem Resistance Mechanisms Fig. 1.Mechanisms of Chemoresistance in TNBC. (A) ABC transporters efflux chemotherapeutics out of cancer cells (B) Overexpression of β-tubulin III subunit induces paclitaxel resistance (C) Mutations in DNA repair enzymes and enzymes altering drug sensitivity (D) Alterations in genes involved in apoptosis prevent chemotherapyinduced apoptosis (E) ALDH1 and glutathione (GSH)/Glutathione-S-transferase (GST) mediate chemotherapeutic inactivation/detoxification (F) Role of NF-ϰB signaling pathway in chemoresistance. BBA Clinical 3 (2015) New finding: overexpression of STAT3 3/23/2016 Richard Gabriel - GLG Pharma Presentation 9

10 GLG s Answer: p-stat3 Inhibitors Uncontrolled STAT3 Activation Causes Hyperproliferation Activation of STAT3 PROTEIN is essential for cell growth division apoptosis Normal cell : activation is switched on/off by positive effectors & negative regulators (only on for short periods of time over the life of the normal cell) Diseased cell switch stays on, process occurs constantly at high levels, keeping cells growing & dividing uncontrollably 3/23/2016 Richard Gabriel - GLG Pharma Presentation 10

11 GLG s p-stat3 Inhibitors: 1. Enhance Chemo and Targeted Therapies and 2. Prevent Acquired Drug Resistance 70% of HER2+ remain Untreated Inhibits HER2 Tumor Growth GLG-302 enhances Trastuzumab (Herceptin) activity in breast cancer TNBC and H&N are ~90% p-stat3 Upregulated Head and Neck Treatment can be Used in TNBC GLG-302 enhances the activity of cisplatin, docetaxel or 5-fluorouracil in head and neck cancer Avg. 50% redu ction Oncotarget, 2014; 5(18) /23/2016 Richard Gabriel - GLG Pharma Presentation 11

12 GLG s p-stat3 Inhibitors: 3. Direct Suppression of Cancer Cell Growth 4. Prevention of Breast Cancer Proliferation Suppression of TNBC and Breast Cancer Stem Cells Prevention of ErbB2 (HER2) positive and ER(-) BC Prevention of Hormone Sensitive BC 3/23/2016 Richard Gabriel - GLG Pharma Presentation 12

13 GLG s p-stat3 Inhibitors: 5. Stimulation of the Immune System by Decreasing Myeloid Derived Suppressor Cells (MDSC) and Cytokines Days of Treatment Days of Treatment Days of Treatment Days of Treatment Data on File GLG Pharma /23/2016 Richard Gabriel - GLG Pharma Presentation 13

14 GLG s p-stat3 Inhibitors: 6. Low Toxicity and Biodistribution Well Tolerated Treatments at High Doses for Long Periods 3/23/2016 Richard Gabriel - GLG Pharma Presentation 14

15 No p-stat3 Inhibitors Either in Development or Approved for Breast Cancers Cancer 2014;121:8-16 BL1 = basal-like subtype 1; BL2, basal-like subtype 2; IM, immunomodulatory subtype; M, mesenchymal subtype; MSL, mesenchymal stem cell-like subtype; LAR, luminal subtype expressing androgen receptor; UNC, unclassified 3/23/2016 Richard Gabriel - GLG Pharma Presentation 15

16 Competitors STAT3 inhibitors are considered one of the most promising new areas of oncological research. Currently, there are no FDA or EU approved STAT3 inhibitors on the market. However, several STAT3 inhibitors are in preclinical development. Three companies: GLG Pharma, Astra Zeneca and Otsuka Pharmaceuticals are currently conducting clinical trials for different cancer indications: OPB31121 (Otsuka Pharmaceuticals) Phase I/II in Hepatocellular Carcinoma OPB (Otsuka Pharmaceuticals) Phase I in Hematologic Malignancies AZD9150 (AZ-Isis-STAT3Rx) Phase I in Hepatocellular Carcinoma Treatment of Triple Negative Breast Cancer with anticancer drugs causes many adverse effects: Drug Tamoxifen Raloxifene Major Adverse Effects Cancer of the Uterus, Stroke, Pulmonary Embolism Deep Vein and Retinal Thrombosis, Pulmonary Embolism, Stroke 3/23/2016 Richard Gabriel - GLG Pharma Presentation 16

17 GLG s $3.7MM EU Grant for TNBC ( ) Work Package 1: The preparation of drug formulations based on therapeutic pharmacologically active substances of GLG-805 or GLG-302 for use in the treatment of TNBC Work Package 2: The research under the use of pharmacologically active substances of GLG-805 or GLG-302 in combination with conventional anti-cancer drugs in order to reduce the development of tumours resistance to treatment with chemotherapeutics Work Package 3: The clinical studies under the safety and efficacy of targeted therapy based on an innovative pharmacologically active GLG-805 or GLG-302 substances in patients diagnosed with triplenegative breast cancer (TNBC) Work Package 4: The development and validation process of the newly diagnostic test to identify STAT3 overexpression. 3/23/2016 Richard Gabriel - GLG Pharma Presentation 17

18 The Project Result- TNBC (Includes HER2+ Cohorts) Complete Phase 1/2 clinical testing: TNBC Phase I/II clinical trials Approval of STAT3 inhibitor for Poland, Europe, USA and other markets within 5 years from completion of the project based on an international program (we will target a shorter time) Combination with other drugs to treat TNBC patients, Center of operations for the discovery, development, manufacturing, packaging and distribution of approved drug products for the global markets located in Poland Continue to add new intellectual properties and technologies to its existing portfolio 3/23/2016 Richard Gabriel - GLG Pharma Presentation 18

19 Protecting GLG Products Formulation Patents Diagnostic Patents Composition of Matter and Use Patents Combi Molecule Patents Drug Screen Patents 3/23/2016 Richard Gabriel - GLG Pharma Presentation 19

20 The GLG Team Track Record 14 Drugs + 70 Diagnostics Some of the drugs GLG Team helped to develop and approve 3/23/2016 Richard Gabriel - GLG Pharma Presentation 20

21 NEXT STEPS Close the First $2MM for current valuation Close a Follow on Round of $8.0MM at higher valuation by Year s End Start S1 Drafting and Bank Selection Target IPO at Right Valuation at the Right Time 3/23/2016 Richard Gabriel - GLG Pharma Presentation 21

22 Thank You 3/23/2016 Richard Gabriel - GLG Pharma Presentation 22