Introducing FSI-174 – Anti-Ckit Antibody 22 January 2019 This Presentation Contains Forward-Looking Statements That Involve Substantial Risks and Uncertainties
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NASDAQ: FTSV Helping Patients Defeat Their Cancer KOL Breakfast to Discuss Forty Seven´s Expanding Pipeline: Introducing FSI-174 – Anti-cKIT Antibody 22 January 2019 This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially” “predict,” “should,” “will” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the success, cost and timing of our product development activities and clinical trials; our expectations about the timing of achieving regulatory approval and the cost of our development programs; our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates; the commercialization of our product candidates, if approved; our plans to research, develop and commercialize our product candidates; our ability to attract collaborators with development, regulatory and commercialization expertise; our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; future agreements with third parties in connection with the commercialization of our product candidates; our ability to maintain, expand, protect and enforce our intellectual property portfolio; our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of third parties; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of our product candidates; regulatory developments in the United States and foreign countries; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the success of competing therapies that are or may become available; and our ability to attract and retain key scientific or management personnel. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward- looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this presentation, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. More information about the risks and uncertainties faced by Forty Seven is contained under the caption “Risk Factors” included in the company’s periodic filings with the Securities and Exchange Commission at www.sec.gov. Forty Seven disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 2 Agenda o Welcome and Introduction Mark McCamish, M.D., Ph.D. o History and Broad Vision for the cKIT Program Irv Weissman, M.D. o First Potential Indications for cKIT – Current Landscape and Maria Grazia Roncarolo, M.D. Unmet Medical Need o Forty Seven´s Approach to cKIT Jens-Peter Volkmer, M.D. o Q&A and closing remarks Mark McCamish, M.D., Ph.D. 3 5F9 is a Novel Macrophage Immune Checkpoint Inhibitor Targeting CD47 Control mAb: No Phagocytosis SIRP⍺ CD47 “Eat me” signal Anti-CD47 mAb: Phagocytosis 5F9 Macrophages Cancer cells o 5F9 enables macrophages to phagocytose cancer cells by blocking the binding of the “don’t eat me” signal CD47 to its receptor SIRPα o Normal cells are not phagocytosed as they do not express “eat me” signals, except for aged red blood cells o Additional external “eat me” signals can be provided by cancer-specific antibodies 4 5F9 Has Applications in Four Treatment Modalities Monotherapy: Proof-of-concept, facilitates phagocytosis and 1 elimination of tumor cells. Provides foundation for Helping Patients Defeat Their Cancer combination therapy. In Combination with Anti-Cancer Antibodies: 2 Synergizes with tumor-targeting antibodies in a 2 3 4 process called antibody-dependent cellular phagocytosis (ADCP). Combination Combination Combination with Anti- with with Cancer Checkpoint Chemotherapy Antibodies Inhibitors In Combination with Checkpoint Inhibitors: Enhances T cell activation by cross-presentation of 3 cancer cell antigens and amplifies the efficacy of checkpoint inhibitors. 1 Monotherapy In Combination with Chemotherapy 4 Induction of pro-phagocytic signals on tumor cells by chemotherapy facilitates synergistic phagocytosis. 5 5F9 Combination With Targeted Antibodies – Rituximab Experience Phase 1b NHL data published in the DLBC Patient Treated with 5F9 – Rituximab New England Journal of Medicine Antibody Combination Baseline Response at 8 weeks * * 7 7 1 1 0 0 2 2 r r e e b b m m e t e c p e e S D * Hypermetabolic calcified left pleural thickening from prior surgery and not lymphoma PET scan Advani et al., ASCO oral presentation 2018 o 56M with primary refractory DLBCL o First clinical publication of a CD47 targeting o Two prior lines of therapy, bulky disease agent – November 1, 2018 o Complete response at 8 weeks 6 5F9 Monotherapy is Safe and Well-Tolerated Solid Tumor Summary (n = 73) Adverse Event (AE) Term AE Grade Patients treated at 10 (3 pts), 20 (39 pts), 30 (25 patients), or 45 (6 patients) mg/kg weekly Any 3 4 Anemia 36 (49%) 8 (11%) 0 Hemagglutination 22 (30%) 1 (1%) 0 Hyperbilirubinemia/Blood bilirubin increased 11 (15%) 3 (4%) 0 Key Points: Thrombocytopenia 9 (12%) 0 0 Neutropenia 2 (3%) 0 0 o Expected red blood cell findings are Lymphopenia/Lymphocyte count decreased 12 (16%) 7 (10%) 3 (4%) easy to manage using a priming dose Fatigue 36 (49%) 0 0 regimen* Headache 33 (45%) 1 (1%) 0 o Well tolerated at high and extended Chills 28 (38%) 0 0 exposures Pyrexia 26 (36%) 0 0 o 5F9 AE profile comparable as Infusion-related reaction 16 (22%) 4 (5%) 0 monotherapy or in combination Nausea 13 (18%) 0 0 o MTD not reached with dose escalation Photopsia 7 (10%) 0 0 up to 45 mg/kg and >250 patients treated as monotherapy or in Back pain 7 (10%) 1 (1%) 0 combination Myalgia 7 (10%) 0 0 AST elevation 4 (5%) 1 (1%) 1 (1%) * Dose-regimen proprietary to Forty Seven, Inc. ALT elevation 4 (5%) 0 1 (1%) AEs observed in ≥ 10% or selected for clinical interest; Data cutoff 24 Jul 2018 7 Catalyst Events Expected in 2019 – 2020 Presented Projected Indication (Study Stage) Therapy 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 2020 Solid Tumor ASCO: 5F9 Safety + Ovarian (Phase 1) Initial Efficacy Monotherapy Acute Myeloid EHA: Leukemia 5F9 Monotherapy (Phase 1) Safety Phase 2 Efficacy Non-Hodgkin’s ASCO: 5F9 + (DLBCL & Lymphoma Phase 1b rituximab Indolent Combination (Phase 1b/2) Safety + Efficacy with Cancer- Lymphoma) Specific Phase 1b Safety Antibodies Colorectal Cancer 5F9 + + Phase 2 (Phase 1b/2) cetuximab Efficacy Phase 1b Ovarian Cancer 5F9 + Safety + (Phase 1b) avelumab Efficacy Combination Phase 1b with Bladder Cancer 5F9+ Safety + Checkpoint (Phase 1b) atezolizumab Inhibitors Efficacy Acute Myeloid Phase 1b 5F9+ Leukemia Safety + atezolizumab (Phase 1b) Efficacy Phase 1b Combination Acute Myeloid Leukemia/ 5F9+ with Myelodysplastic Syndrome Safety + azacitidine Chemotherapy (Phase 1b) Efficacy 8 ASCO – American Society of Clinical Oncology; EHA – European Hematology Association Our Pipeline Worldwide Drug Candidate/Focus Discovery Preclinical Phase 1 Phase 2 Phase 3 Rights Solid Tumor & Ovarian Monotherapy AML Mono and Combo: Azacitidine Tumor NHL Combo: Rituximab Targeting 5F9 Antibody CRC Combo: Cetuximab Anti-CD47 Combinations Antibody Ovarian: Avelumab T Cell Checkpoint Bladder: Atezolizumab Inhibitor Combinations AML: Atezolizumab FSI-189 Solid Tumor Anti-SIRPα Antibody FSI-174 HSC/Bone Marrow Transplant Anti-cKIT Antibody 9 5F9 Antibody