Calithera Biosciences. September 2018
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1 Calithera Biosciences September 2018
2 Forward-Looking Statements This presentation and the accompanying oral commentary contain forward looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of We may, in some cases, use terms such as believe, will, may, estimate, continue, anticipate, intend, should, plan, might, approximately, expect, predict, could, potentially or the negative of these terms or other words that convey uncertainty of future events or outcomes to identify these forward looking statements. All statements other than statements of historical facts contained in this presentation and the accompanying oral commentary are forward looking statements, and such forward looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: plans regarding our anticipated clinical trials for our product candidates, including CB- 839 and CB-1158, the potential safety, efficacy and other benefits of and market opportunity of product candidates, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, statements relating to the development, regulatory and sales milestone payments of CB-1158 in connection with our collaboration with Incyte Corporation, our intellectual property position and cash needs. Forward looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward looking statements. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our Quarterly Report on Form 10 Q for the for the quarter ended June 30, 2018, filed with the Securities and Exchange Commission on August 7, Forward looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward looking statements contained in this presentation and the accompanying oral commentary. Any forward looking statements that we make in this presentation and the accompanying oral commentary speak only as of the date of this presentation. We assume no obligation to update our forward looking statements whether as a result of new information, future events or otherwise. 2
3 Our onco-metabolism approach brings a new and unique perspective to fighting cancer VISION: Our goal is to be a fully-integrated biotechnology company that develops and commercializes pioneering small molecule drugs
4 Investment Highlights Four internally discovered clinical stage compounds Experienced management team with drug discovery track record Diversified portfolio of tumor metabolism, immunoncology and cystic fibrosis 4
5 Near Term Goals Gain approval of the glutaminase inhibitor CB-839 in renal cell carcinoma Data from randomized trials expected in 2019 and 2020 Establish the arginase inhibitor INCB as an active therapy in cancer Single agent and combo data anticipated Develop the arginase inhibitor CB-280 as a new treatment modality for cystic fibrosis IND filing expected in 1H2019 Take the oral small molecule CD73 inhibitor CB-708 into the clinic in cancer IND filing expected in
6 Pipeline Glutaminase Inhibitor CB-839 mrcc + Cabozantinib mrcc + Everolimus Solid Tumors + Nivolumab PIK3CAm CRC + Capecitabine (IST) Arginase Inhibitor INCB Immuno-oncology Monotherapy Discovery Pre-IND Phase 1 Phase 2 Phase 3 CANTATA Trial Potential registration trial ENTRATA Trial Combos + Pembrolizumab + Chemotherapy Arginase Inhibitor CB-280 Cystic Fibrosis Small Molecule CD73 Inhibitor CB-708 Immuno-Oncology 6
7 Glutaminase Inhibitor CB-839 Tumor and Immune Metabolism Program
8 CB-839 Multiple Potential Solid Tumor Markets Melanoma Ovarian Gliomas Renal Cell Lung Colorectal Breast 8
9 Mechanism of Action of CB-839 Mutated oncogenes can make cancer cells dependent on glutamine for growth and survival Glutaminase inhibitors have synergistic effects when combined with many cancer drugs CB-839 is a well tolerated, orally bioavailable, potent and allosteric inhibitor of glutaminase Kinase inhibitors of growth factor pathways Block glucose utilization CB-839 Blocks glutamine metabolism + Dual nutrient deprivation Taxanes, cdk4/6 and PARP inhibitors Block the cell cycle CB Blocks DNA synthesis Dual inhibition of cell division PD-1 inhibitors Activate T cells CB-839 Supplies T cells glutamine + Dual activation of T cells 9
10 High Unmet Need Remains for Patients with Metastatic RCC Despite an Evolving Landscape Market size expected to increase from $2.7B to $6.7B in ,000 patients diagnosed with RCC in major markets Almost half of all metastatic treated patients are 2L+ 31% 12% 55% 1L 2L 3L 4L Drug treated mrcc patients by line of therapy Sources: Decision Resources 2017, Renal Cell Carcinoma; Major Markets = US, UK, France, Germany, Spain, Italy, Japan 10
11 Renal Cell Carcinoma Phase 1 Combination Study Design Objective Evaluate safety, anti-tumor activity, and determine recommended dose of CB-839 in combination with cabozantinib or everolimus in patients with metastatic RCC Dose Escalation Dose Expansion CB-839 ( mg BID) + Cabozantinib (60 mg QD) Clear Cell & Papillary CB-839 ( mg BID) + Everolimus (10 mg QD) Clear Cell & Papillary Tumor response assessed by RECIST every 8 weeks 11
12 Renal Cell Carcinoma Phase 1 Safety Data Treatment-related adverse events occurring in 15% patients a CB Everolimus n = 27 Adverse Event, n (%) All Grades Grade 3 Any 26 (96) 13 (48) Decreased appetite 9 (33) 0 Rash 8 (30) 2 (7) Anemia 7 (26) 2 (7) Thrombocytopenia 7 (26) 1 (4) b Diarrhea 6 (22) 0 Fatigue 6 (22) 3 (11) Mucosal inflammation 6 (22) 0 AST increased 5 (19) 0 Creatinine increased 5 (19) 0 Proteinuria 5 (19) 0 Stomatitis 5 (19) 1 (4) Dermatitis acneiform 4 (15) 0 Dysgeusia 4 (15) 0 Epistaxis 4 (15) 0 Hyperglycemia 4 (15) 2 (7) Myalgia 4 (15) 0 Nausea 4 (15) 0 CB Cabozantinib n = 12 Adverse Event, n (%) All Grades Grade 3 Any 12 (100) 4 (33) Diarrhea 7 (58) 1 (8) ALT increased 6 (50) 0 AST increased 5 (42) 0 Decreased appetite 4 (33) 0 Nausea 4 (33) 0 Rash 4 (33) 0 Fatigue 3 (25) 0 Abdominal pain 2 (17) 0 Dehydration 2 (17) 0 Dysgeusia 2 (17) 0 Mucosal inflammation 2 (17) 0 Proteinuria 2 (17) 0 Stomatitis 2 (17) 0 Thrombocytopenia 2 (17) 1 (8) c Vomiting 2 (17) 0 a Related to either CB-839 or combination agent; b 1 DLT at 400 mg ; c 1 DLT at 600 mg Safety data cutoff: Oct 23,
13 Tumor Reduction in Metastatic Renal Cell Carcinoma Patients Cabozantinib Combination Prior Lines of Advanced/Metastatic Therapy Efficacy data cutoff: Dec 22,
14 40% Response Rate in Clear Cell RCC Cabozantinib Combination CB Cabozantinib Response All Patients n = 12 Clear Cell Only n = 10 Partial response 4 (33%) 4 (40%) Stable disease 8 (67%) 6 (60%) Progressive disease 0 0 Disease control rate 100% 100% Compares favorably to Cabozantinib monotherapy 17% response rate 1 1 Choueiri TK, et al. Lancet Oncol. 2016;17(7):
15 Disease Control and Favorable PFS in Renal Cell Carcinoma Everolimus Combination Best responses: 1 PR and 21 SD with a 92% DCR Median progression-free survival exceeds that of historic everolimus monotherapy (3.7 months for 3rd line) 1 1 Wells JC, et al. Eur Urol. 2017;71(2):
16 RANDOMIZATION 1:1 CANTATA Study Design n=300 Renal Cell Carcinoma Second or third line RCC with prior anti-angiogenic agent or nivolumab + ipilimumab STRATIFICATION Prior anti- PD(L)1 CB-839 (800 mg BID) + Cabozantinib (60 mg QD) No prior cabozantinib or MET inhibitor Enrollment in US, EU, Australia and New Zealand IMDC risk category Cabozantinib (60 mg QD) + Placebo PRIMARY ENDPOINT: PFS SECONDARY ENDPOINT: Survival 16
17 RANDOMIZATION 2:1 ENTRATA Study Design n=66 Renal Cell Carcinoma Third line+ with prior anti-vegf TKI and either cabozantinib or anti-pd(l)1 therapy STRATIFICATION Number of prior TKI Therapies CB-839 (800 mg BID) + Everolimus (10 mg QD) No prior mtor inhibitors Enrollment in US MSKCC risk category Everolimus (10 mg QD) + Placebo PRIMARY ENDPOINT: PFS SECONDARY ENDPOINT: Survival 17
18 CB Capecitibine in PIK3CA Mutant Colorectal Cancer Refractory colorectal cancer remains an unmet need Third line median PFS is 2 months and median survival is 6 months PIK3CA mutant tumors in animals are more sensitive to CB-839 in combination with 5-FU PIK3CA mutations occur in 15-20% of CRC Ph1b/2 Investigator Sponsored Trial led by Case Western was initiated in 2016 Ph 1b Dose Escalation CB-839 ( mg BID) + capecitabine* (1000 mg/m 2 ) (n=16) Cancers for which capecitabine is SOC Ph2 Dose Expansion CB-839 (800 mg BID) + capecitabine (5-FU therapy) (n=29) PIK3CA-mutant CRC refractory to prior 5-FU *Capecitabine is an oral fluoropyrimidine; similar to 5-FU 18
19 P r o g r e s s i o n - f r e e s u r v i v a l CB Capecitibine Phase 1b Data Presented at ASCO CRC patients were refractory to 5-FU therapy 7 PIK3CA mutant 6 wild type Safety Minimal toxicity Ph 2 dose of CB-839 established at 800 mg BID Median PFS 26 week (6.5 mo) PFS for PIK3CA mutant CRC 16 week (4 mo) PFS for wild type CRC Compares favorably to 2 mo PFS in 3L CRC Progression Free Survival Subgroup Analysis of CRC Pts by PIK3CA Status p= PIK3CA mutant CRC PIK3CA wild-type CRC W e e k 19
20 Arginase Inhibitor INCB Collaboration With Incyte
21 T-Cells Deprived of Arginine are Dormant Yet Expand When Arginine is Replenished Arginine Nutrient sensor pathways Expression of TCRz Production of IFNg Proliferation = Arginase MDSC/neutrophil T-cell Arginase inhibitors may enhance the efficacy of other IO agents including checkpoint Inhibitors, chemotherapy, engineered T-cells and vaccines 21
22 A Small Arginine Decrease is Immunosuppressive to Activated T-Cells Normal plasma arginine levels are mm Arginine levels below 40 mm suppress T-cell proliferation 22
23 Cancer Patients Have Arginase + Myeloid Cell Infiltrates in Tumors, and High Arginase/ Low Arginine in Blood H&E Plasma Arginase Arginase 1 HNSCC Plasma Arginine Head and Neck tumor 23
24 INCB001158: Phase 1 Trial PK and PD Data INCB is an oral and potent inhibitor of arginase that was discovered at Calithera At doses 50 mg BID, 90-95% of plasma arginase is inhibited and plasma arginine levels increase several fold Generally well tolerated: One case each of anemia, fatigue, increased AST, myalgia; No SAEs Reversible and asymptomatic elevations of urinary orotic acid > 5X ULN threshold in 2 patients Post Dose Plasma Arginase Activity Post Dose Plasma Arginine 24
25 INCB001158: Preliminary Evidence of Peripheral Immune Modulation INCB treatment increased the number of peripheral circulating PD-1 + T-cells INCB00158 also increased the level of CD3z cell surface expression on cytokineproducing NK cells CD4 + /FoxP3 - CD8 + NK cells 25
26 INCB Broad Development Program Monotherapy Cohorts PD-1 combo (naïve) PD-1 combo (experienced) Chemotherapy combos NSCLC MSS colorectal NSCLC FOLFOX Colorectal Gastric Squamous H&N Melanoma Urothelial Gem/Cis Other Mesothelioma MSI Colorectal Paclitaxel 26
27 INCB Broad Development Strategy Focus on disease indications where arginase expression is high Develop as a monotherapy, and in combination with PD-1 inhibitors Enroll PD-1 experienced patients (progression or stable disease as best response to PD-1 in most recent therapy) and PD-1 naïve patients Develop in combination with chemotherapy Use biomarkers in clinical development Gated development plan 27
28 Incyte Partnership Broad clinical development program for INCB $45M upfront + $8M equity investment $12M milestone received Co-development co-commercialization deal 40% U.S. profit share Low to mid-double digit royalties ex-us Up to $430M potential milestones Calithera has rights to develop arginase inhibitors including CB-280 in select indications outside oncology 28
29 Arginase Inhibitor CB-280 Cystic Fibrosis Program
30 Cystic Fibrosis Program CB-280 Despite recent advances in new therapies, there is still unmet need CFTR enhancers leave room for clinical improvement Multiple novel mechanisms (anti-infectives, anti-inflammatory agents) are in development Arginine-nitric oxide modulation has shown preclinical and clinical efficacy CB-280 is an analog of INCB CB-280 will be the first arginase inhibitor to enter the clinic in CF IND and Phase 1 initiation expected 1H19 30
31 CB-280 May Have Beneficial Effects on FEV1 and Exacerbations CFTR Defect Neutrophils in lungs Arginase CB-280 Arginine Nitric Oxide T cell/nk cell function Arginine Nitric Oxide T cell/ NK cell function Direct Bronchodilation Anti-infective Immune Stimulator FEV1 Pulmonary exacerbations 31
32 CD73 Inhibitor CB-708 Immune Metabolism Program
33 CD73 Small Molecule Inhibitor of the Adenosine Pathway CD73 is an enzyme that converts AMP to adenosine It is composed of a dimer that is linked to the cell membrane via GPI anchors Hydrolysis of the GPI anchor results in the shedding of soluble CD73 that is enzymatically active CB-708 is potent oral small molecule that binds to the active site of CD73 CB-708 inhibits both the secreted and cell surface forms of CD73 IND and Phase 1 trial initiation in 2019 AMP Phosphate Adenosine CD73 extracellular intracellular Knapp 2012 Structure 33
34 Adenosine is Immunosuppressive and Inhibits Effector T cells Tumor cells releases extracellular ATP following immunogenic death CD39 and CD73 are cell surface enzymes that convert ATP to adenosine Anti-inflammatory effects of adenosine are due to binding of the A2AR and A2BR receptors Adenosine is immunosuppressive to Tregs, APCs and activated T-cells Ohta 2014 Frontiers in Immunol 34
35 Financials Financial strength and supportive partnerships Cash and securities of $152.2 at June 30, M shares outstanding No debt Significant funding from collaboration and potential future milestones 35
36 Milestones Report additional CB-839 preclinical data with novel combination agents in 2Q18 Report colorectal cancer data of CB FU mid-year Report update from the Phase 2 TNBC study of CB paclitaxel by year-end Announce novel pipeline candidate by year-end Initiate Phase 2 CANTATA Trial 2Q18 Develop INCB with multiple combination trials open by mid-year Complete enrollment of the Phase 2 ENTRATA Trial 2018 or 1Q
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