Compass Therapeutics, Inc. · NASDAQ:CMPX
Compass Therapeutics — Investor Presentation (May 2022)
36 slides from Compass Therapeutics's investor presentation, May 4, 2022
Slide 1: Compass Therapeutics Presentation May 4, 2022
DO NOT DISTRIBUTE WITHOUT PERMISSION | © 2022 Compass Therapeutics Presentation May 4, 2022
Slide 2: Disclaimer
DISCLAIMER This presentation has been prepared by Compass Therapeutics, Inc. ("we," "us," "our," or the “Company”). Statements contained herein are made as of the date of this presentation unless stated otherwise, and this presentation shall not under any circumstances create an implication that the
Slide 3: Advanced Biliary Tract Cancers (BTC)
Advanced Biliary Track Cancers (BTC) Richard M. Goldberg MD Professor and Director Emeritus The West Virginia University Cancer Institute
Slide 4: Subtypes of BTC
Subtypes of BTC • Gallbladder cancer (GBCA), • Cholangiocarcinoma – intrahepatic [IHCC], – Perihilar [PCCA], – Extrahepatic [ECC] • Ampulla of Vater cancer (AVC)
Slide 5: BTC Epidemiology, 2021
BTC Epidemiology, 2021 US Worldwide Cases 18,300 210,887 Deaths 11,310 (62%) 173,974 (84%) • Lifetime risk: Highest in Chile and Asian countries • 76% Increase in incidence over last 2 decades • Risk factors: Inherited, liver flukes, chronic liver or biliary inflammation, obesity, tobacco use
Slide 6: Presentation
Presentation • Jaundice, yellow eyes, itching, dark urine, light colored stool • Loss of appetite and weight loss • Abdominal pain • Night sweats • Found incidentally at the time of gall bladder surgery
Slide 7: BTC treatment paradigm
Resection + Adjuvant chemotherapy Capecitabine (CC/G8C) Gemeitabine (AMP) Cisplatin Gemcitabine ¢ Chemotherapy FOLFOX (trials ongoing) IDH mutant IDH inhibitor (trials ongoing) [Second line» Local treatment \Ts (trials ongoing) FGFR2 fusions inhibitors (trials ongoing) Immunotherapy CARTS Check-poin
Slide 8: Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer
Original Article Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer Juan Valle, M.D., Harpreet Wasan, M.D., Daniel H. Palmer, M.D., Ph.D., David Cunningham, M.D., Alan Anthoney, M.D., Anthony Maraveyas, M.D., Ph.D., Srinivasan Madhusudan, M.D., Ph.D., Tim Iveson, M.D., Sharon Hug
Slide 9: Patient Enrollment, Randomization, and Treatment
Patient Enrollment, Randomization, and Treatment Valle J et al. N Engl J Med 2010;362:1273 - 1281 • The ABC - 02 Study • Published 2010 • Determined the current standard of care for first line treatment of advanced CCA
Slide 10: ABC-02 Outcomes
ABC - 02 Outcomes Valle J et al. N Engl J Med 2010;362:1273 - 1281 Median Overall Survival Gem + Cis: Gem: 11.7 mos 8.1 mos Median Progression Free Survival Gem + Cis: Gem: 8.0 mos 5.0 mos
Slide 11: TOPAZ-1: Durvalumab with gemcitabine plus cisplatin
A Phase 3 randomized, double - blind, placebo - controlled study of durvalumab in combination with gemcitabine plus cisplatin in patients with advanced biliary tract cancer: TOPAZ - 1
Slide 12: TOPAZ-1 study design
TOPAZ-1 study design TOPAZ-1 is a double-blind, multicenter, global, Phase 3 study Key eligibility Locally advanced or metastatic BTC Durvalumab 1500 mg Q3w Durvalumab 1500 mg (ICC, ECC, GBC) + GemCis (up to 8 cycles) (Q4W until PD + Previously untreated if unresectable or metastatic at initial diag
Slide 13: Primary endpoint: OS
Primary endpoint: OS ia G8 | a Ges (Sep es momen || os isco) | ©6097) 021 Probability of OS ° 8 2 8 18 Number of subjects at risk Time from randomization (months) Durvalumab+GemCis 341 309 268 208 135 79 49 Placebo+Gemcis 344 317 261 183 125 65 28 10 4 ° (08, orl sural ASCO Gastrointestinal csonio w
Slide 14: Secondary endpoint: PFS
Secondary endpoint: PFS Fad pan 10 075 09 (0.63-0.89) OES os Sette! atin oot or PFS | @ o7 E © os 2 os Abe emo PFS: emo PFS: t2me PFS: a 58.3% 34.8% 16.0% 2 os a6 28% com 02 on oo Hy 3 3 5 rr a ae) for aciocat i “The rotiraonatanin (mois) DumalumabsGemcis 3412588] ww 5 o Placobo'sGemcle ae ss 7 ‘ 0
Slide 15: Secondary endpoint: Tumor response
Secondary endpoint: Tumor response
Slide 16: Survival after 1st Line Therapy
Survival after 1 st Line Therapy • In ABC - 02 and Topaz - 1 median survival post progression was about 3 months
Slide 17: Unmet Need for Second Line Therapies for Cholangiocarcinoma
Unmet Need for Second Line Therapies for Cholangiocarcinoma ڻ Historical data of outcomes in 2L chemo - based therapies after gemcitabine/plat - based combo therapy failure result in dismal outcomes with limited progression free survival: Author Treatment Phase No. of patients PFS (mo) OS (mo) ORR (
Slide 18: Treatment Paradigm for BTC
1L treatment Source: Adapted from NCCN guidelines Doublet chemo of gemcitabine + cisplatin (based on ABC - 02) Treatment Paradigm for BTC 1L treatment 2L treatment FOLFOX Pemigatinib (for pts with FGFR2 mutation) Ivosidenib (for pts with IDH1 mutation) PD - 1 Inhibitor (for pts with MSI - H tumors P
Slide 19: Targeted Therapy in BTC
Targeted Therapy in BTC • IDH - 1 • Microsatellite Instability (MSI - H) • NTRK fusion • FGFR fusion 9.3% 4.3% 0.75% <0.50% Eligible for current targeted therapies ~14% Presented by:
Slide 20: Second-line FOLFOX versus active symptom control (ABC-06)
Second - line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC - 06): a phase 3, open - label, randomised, controlled trial Angela Lamarca, PhD, Prof Daniel H Palmer, PhD, Harpreet Singh Wasan, MD, Paul J Ross, PhD, Yuk Ting Ma, PhD, Arvind Arora, MD, Stephen
Slide 21: ABC-06 Trial Schema
Figure 1 The Lancet Oncology 2021 2690 - 7 1DOI: (10.1016/S1470 - 2045(21)00027 - 9) Copyright © 2021 ished by Elsevier Ltd. This is an Open Access article under the CC B 4. i se. Terms and Conditions ABC - 06 Trial Schema
Slide 22: Median Survival
Median Survival The Lancet Oncology 2021 2690 - 7 1DOI: (10.1016/S1470 - 2045(21)00027 - 9) Copyright © 2021 ished by Elsevier Ltd. This is an Open Access article under the CC B 4. i se. Terms and Conditions Median Overall Survival ASC + FOLFOX: 6.2 mos ASC: 5.3 mos Patient selection explains The lo
Slide 23: Chemotherapy in BTC
Chemotherapy in BTC • NCCN Guidelines – First Line: Gem/Cis doublet • 26.1% ORR • 3.6 month increase in median OS vs. Gem alone (HR=0.64) • Valle, et al. (2010) – Second - line: FOLFOX • 5% ORR • 0.9 month increase in median OS vs. supportive care (HR=0.69) • Lamarca, et al. (2021) • Taxanes – Neith
Slide 24: There clearly are unmet needs in managing BTC
There clearly are unmet needs in managing BTC Presented by:
Slide 25: CTX-009 Update: Executive Summary
CTX - 009 Update: Executive Summary ڻ Phase 1: 8 PRs in patients with advanced cancers both as a monotherapy and in combination with chemotherapy with an acceptable safety profile ڻ Phase 2 (Stage 1): CTX - 009 in combination with paclitaxel in patients with BTC is ongoing ڻ Interim update (data as
Slide 26: Phase 1b Combination Study with Chemo (N=17)
Phase 1b Combination Study with Chemo (N=17) ڻ 4 arms: ڻ 10.0 and 12.5 mg/kg CTX - 009 ڻ Irinotecan or paclitaxel ڻ Activity: ڻ 4 PRs, 3 confirmed, including a confirmed PR in pancreatic cancer ڻ 9 Stable Disease (SD) ڻ Overall Response Rate (ORR): 24% ڻ Clinical Benefit Rate (CBR): 77% (PR + SD) 4
Slide 27: Phase 1b Combination Study Waterfall Plot
36.8% 22.7% 16.3% 7.4% 0.0% - 0.7% - 10.4% - 12.7% - 17.0% - 18.3% - 19.7% - 20.6% - 28.0% - 31.4% - 34.9% - 41.4% - 61.6% - 30.0% - 40.0% - 50.0% - 60.0% - 70.0% - 80.0% - 10.0% - 20.0% 10.0% 0.0% 30.0% 20.0% 50.0% 40.0% 70.0% 60.0% 80.0% Tumor Growth (%) Patient Phase 1b Data (17 Patients) CTX - 0
Slide 28: Phase 1b Combination Safety Data
Drug - related adverse events observed in > 1 patient Total (n) Total (%) Grade 3 (n) Grade 3 (%) Hypertension* 5 29% 4 24% Pulmonary hypertension (all grade 1) 5 29% 0 0% Neutropenia** Anemia** Thrombocytopenia** 4 3 2 24% 18% 12% 3 3 2 18% 18% 12% Proteinuria 3 18% 0 0% Dyspnea 3 18% 0 0% Fatigue
Slide 29: Phase 2 Combination Study: CTX-009 Plus Paclitaxel
Phase 2 Combination Study: CTX - 009 Plus Paclitaxel Phase 2 Study Design: ڻ Patients with biliary tract cancers after one or two prior therapies ڻ CTX - 009 at 10 mg/kg biweekly plus paclitaxel 80 mg/m 2 weekly 3 of 4 weeks ڻ Simon 2 Stage adaptive design: ڻ Stage 1: 21 patients ORR ڻ Stage 2: if
Slide 30: Phase 2 Combination Study Status
Phase 2 Combination Study Status ڻ November 1, 2021 (previously reported interim data) ڻ 24 patients had been enrolled; 17 patients evaluable for response ڻ Efficacy data: 5 PRs; 29% ORR ڻ April 14, 2022 (interim data) ڻ 24 patients enrolled; 22 patients evaluable for response ڻ Efficacy data: 10 PR
Slide 31: Phase 2: Patient Baseline and Demographics
Phase 2: Patient Baseline and Demographics 24 Total Patients Age Median (years) 61.5 Gender, n(%) Male 14 (58%) Female 10 (42%) ECOG performance status, n(%) 0 13 (54%) 1 11 (46%) 24 Total Patients Prior systemic therapies, n(%) 1 11 (46%) 2 13 (54%) Prior Gem/Cis regimen 23 (96%) BTC subtype, n (%)
Slide 32: Phase 2 Waterfall: ORR = 42%; CBR = 92%
Phase 2 Waterfall: ORR = 42%; CBR = 92% DO NOT DISTRIBUTE WITHOUT PERMISSION | 2022 10 - 1 - 7 - 7 - 9 - 12 - 12 - 17 - 17 - 19 - 20 - 23 - 33 - 33 - 37 - 38 - 41 - 43 - 44 - 44 - 52 - 57 - 60 - 50 - 40 - 30 - 20 - 10 0 1 2 3 4 5 6 7 8 9 10 13 14 15 16 17 18 19 20 21 22 Intrahepatic cholangiocarcino
Slide 33: Swimmer Plot: Median Time on Study
Swimmer Plot: Median Time on Study ~ 6 Months DO NOT DISTRIBUTE WITHOUT PERMISSION | 2022 11 Days on Treatment
Slide 34: Safety Data: Treatment-Related Adverse Events
Safety Data: Treatment - Related ≥ Grade 3 Adverse Events Event 24 total Patients N (%) Neutropenia 12 (50.0%) Hypertension 4 (16.7%) Anemia 3 (12.5%) Thrombocytopenia 2 (8.3%) Additional events observed in 1 patient: Intestinal perforation, Asthenia, Catheter site hemorrhage, Fatigue, Cholangitis,
Slide 35: CTX-009 Next Steps
CTX - 009 Next Steps ڻ Initiate Stage 2 of the Phase 2 BTC study in the US in early Q3 ڻ Initiate Phase 2/3 study in patients with colorectal cancer in the third line setting in the US in Q4 2022 ڻ Initiate Phase 2 study in patients with advanced ovarian cancer in the US in Q1 2023 ڻ Continue to eva
Slide 36: CTX-009 Interim Phase 2 Study Summary
CTX - 009 Interim Phase 2 Stu dy Summary ڻ 24 patients with BTC have been enrolled and dosed ڻ 10 partial responses (PRs) for a 42% ORR in patients treated in the second - and third - line settings (54% of patient were treated in the 3 rd line setting) ڻ Other regimens in BTC: ڻ FOLFOX (NCCN guideli
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