Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (November 2024)
41 slides from Curis's investor presentation, November 2024
Slide 1: Corporate Presentation November 2024
Corporate Presentation November 2024
Slide 2: Cautionary note regarding forward looking statements and disclaimers
Cautionary note regarding forward looking statements and disclaimers This presentation contains certain forward-looking statements about Curis, Inc. (“we,” “us,” or the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “expect(s),” “beli
Slide 3: Emavusertib is a novel, first-in-class inhibitor of IRAK4
Emavusertib is a novel, first-in-class inhibitor of IRAK4 • Being evaluated in Phase 1/2 clinical studies Acceptable safety profile in monotherapy & combination in NHL, AML, and Solid Tumors • Cash runway into mid-2025 o Sufficient to meet anticipated Demonstrated synergy near term milestones with B
Slide 4: Broad Market Opportunity in NHL, AML, and Solid Tumors
Broad Market Opportunity in NHL, AML, and Solid Tumors Significant market opportunities Additional potential opportunities in current development programs with NHL expansion PCNSL FLT3m AML ABC- WM MCL MZL CLL/SLL DLBCL US Incidence per 100K 0.51 1.32 4.23 0.55 0.56 1.57 2.08 4.59 Newly Diagnosed Pe
Slide 5: Emavusertib in NHL
Emavusertib in NHL fo CUMS’
Slide 6: Emavusertib's Mechanism in NHL
Emavusertib’s Mechanism in NHL BCR Pathway TLR Pathway B cell TLR1 TLR2 TLR4 TLR5 2 pathways drive NF-ĸB receptor TLR6 (which drives NHL) blocking both pathways Endosome TLR7 TLR8 TLR9 (block BCR with BTKi – block TLR with emavusertib) ibrutinib (BTKi) BTK enables dual blockade of NF-ĸB Myddosome CA
Slide 7: Emavusertib synergy with BTKi in NHL demonstrated in preclinical models
Emavusertib synergy with BTKi in NHL demonstrated in preclinical models CA-4948 + Ibrutinib Tumor Growth in OCI-Ly10 Model 1400 Monotherapy vs. Combination D in NHL vehicle Ve emavusertib + BTKi 1200 Mean Tumor Volume (mm3) + SEM CA dual blockade of the TLR and BCR pathways 1000 m was demonstrated t
Slide 8: Strategy in NHL
Strategy in NHL ❶ Demonstrate safety 31 patients1 treated in TakeAim Lymphoma Ph 1b study, acceptable safety profile established, no overlapping dose-limiting toxicity with ibrutinib ❷ Demonstrate single-agent activity Single-agent activity demonstrated, with patients remaining on study up to 4 year
Slide 9: Emavusertib safety profile in NHL
Emavusertib safety profile in NHL1 • 31 patients treated with emavusertib in 100 mg BID 200 mg BID 300 mg BID Total Grade 3+ TRAE Ema + Ibr Ema + Ibr Ema + Ibr combination with ibrutinib in multiple NHL in >1 Patient (N=6) (N=18) (N=7) (N=31) subtypes n (%) n (%) n (%) n (%) • Shown to be well toler
Slide 10: Strategy in NHL
Strategy in NHL ❶ Demonstrate safety 31 patients1 treated in TakeAim Lymphoma Ph 1b study, acceptable safety profile established, no overlapping dose-limiting toxicity with ibrutinib ❷ Demonstrate single-agent activity Single-agent activity demonstrated, with patients remaining on study up to 4 year
Slide 11: Single-agent activity demonstrated in NHL
Single-agent activity demonstrated in NHL Percent Change in Tumor Burden from Baseline Case Study in Dose Response (WM patient) (6 patients treated for ~1 year or longer) 50 mg 100 mg 2950 2850 2750 200 mg 2650 2550 2450 2350 2250 Tumor reduction 2150 2050 Dosing increases led sustained for up to 3+
Slide 12: Strategy in NHL
Strategy in NHL ❶ Demonstrate safety 31 patients1 treated in TakeAim Lymphoma Ph 1b study, acceptable safety profile established, no overlapping dose-limiting toxicity with ibrutinib ❷ Demonstrate single-agent activity Single-agent activity demonstrated, with patients remaining on study up to 4 year
Slide 13: BTKi is currently used in 6 NHL subtypes
BTKi is currently used in 6 NHL subtypes PCNSL was selected as our first NHL indication for pursuing FDA approval Tumor Incidence in U.S. Key Targets of Interest Therapies Used ABC-DLBCL 2 per 100,000 ~ 6,800 patients IRAK4, MYD88, CD79, NF-kB R-CHOP, BTKi PCNSL 0.5 per 100,000 ~ 1,700 patients IRAK
Slide 14: R/R PCNSL selected for 1st NHL indication
R/R PCNSL selected for 1st NHL indication Critical unmet need – patients often proceed to hospice after 2 lines of treatment Salvage Line Stay on BTKi – add emavusertib emavusertib blocking both the TLR and BCR pathways 1st Line 2nd Line + maximizes downregulation of NF-κB and may BTKi (ibrutinib) l
Slide 15: Encouraging clinical data in R/R PCNSL
Encouraging clinical data in R/R PCNSL Results for patients treated with emavusertib + ibrutinib, after they have progressed on prior BTKi 10% * Tumor Reduction Duration of Treatment 0% Best change in disease burden from baseline -10% -20% -30% 6 Responses Duration of Response > 6 months -40% in 10
Slide 16: PCNSL Case Study
PCNSL Case Study Patient with R/R PCNSL treated with emavusertib + ibrutinib Male patient, 53 yrs Diagnosis: PCNSL diagnosed on 30 Jun 2020 Baseline: Depression, elevated LFTs, loss of appetite, cerebral edema, mixed IBS, hiatal hernia, GERD, essential hypertension, and obstructive sleep apnea Prior
Slide 17: PCNSL Case Study
PCNSL Case Study Patient with R/R PCNSL who achieved CR on emavusertib + ibrutinib Relapsed on ibrutinib SD CR CR CR CR Nov 2022 Jan 2023 Apr 2023 May 2023 Aug 2023 Feb 2024 May 2024 (Screening) (Day 43) (Day 81) (Day 187) (Day 349) (Day 442) Tumor Size Disease Stable Tumor Absent Tumor Absent Tumor
Slide 18: Strategy in NHL
Strategy in NHL ❶ Demonstrate safety 31 patients1 treated in TakeAim Lymphoma Ph 1b study, acceptable safety profile established, no overlapping dose-limiting toxicity with ibrutinib ❷ Demonstrate single-agent activity Single-agent activity demonstrated, with patients remaining on study up to 4 year
Slide 19: Anti-cancer activity shown across multiple NHL subtypes
Anti-cancer activity shown across multiple NHL subtypes Data presented at ASH 2023 supports emavusertib + BTKi combination in additional NHL subtypes All patients (n=19), multiple NHL subtypes No Prior BTKi Failed Prior BTKi Best % Change in Tumor Burden • Heavily pre-treated patients (1-10 prior li
Slide 20: Summary in NHL
Summary in NHL Lymphoma • Emavusertib has demonstrated anti-cancer activity in R/R PCNSL • Next steps: ⁻ Work with FDA and EMA to align on a registrational path in R/R PCNSL ⁻ Prioritize next NHL indications (after PCNSL) that could benefit from the dual-blockade of NF-ĸB 20
Slide 21: Emavusertib in AML
Emavusertib in AML fo CUMS’
Slide 22: Emavusertib binds to IRAK4 and FLT3, blocking both pathways
Emavusertib binds to IRAK4 and FLT3, blocking both the TLR and FLT3 pathways Emavusertib Emavusertib Kinase Interaction Map Binding Affinity FLT3 Target Kd nM IRAK4 IRAK1 12,000 IRAK2 >20,000 IRAK3 8,500 IRAK4 DYRK1A 23 25 Binds tightly to IRAK4 CLK 1, 2, 4 FLT3 WT 31 Haspin FLT3 (D835H) FLT3 (D835V
Slide 23: IRAK4-L is an independent and powerful driver of disease in AML
IRAK4-L is an independent and powerful driver of disease in AML IRAK4-L is expressed in nearly all AML patients IRAK4-L is oncogenic in AML 800 Knocking out IRAK4 IRAK4-L stops leukemic activity IRAK4-S (similar findings using CRISPR/CAS9) 600 Sum of IRAK4 variants Control 400 200 adding back IRAK4-
Slide 24: Strategy in AML
Strategy in AML ❶ Demonstrate safety 123 patients1 treated in TakeAim Leukemia Ph 1/2 study, acceptable safety profile established ❷ Demonstrate single-agent activity Single-agent activity observed; next step is to confirm these initial findings in a larger number of patients ❸ Pursue fastest path t
Slide 25: Safety Profile of Emavusertib as Monotherapy in AML
Safety Profile of Emavusertib as Monotherapy in AML 200 mg BID 300 mg BID 400 mg BID 500 mg BID Total Grade 3+ TRAE > 1 patients (n = 27) (n = 78) (n = 15) (n = 3) (n=123) • 123 patients treated with emavusertib n (%) n (%) n (%) n (%) n (%) in TakeAim Leukemia Study Number of patients having 4 (14.
Slide 26: Strategy in AML
Strategy in AML ❶ Demonstrate safety 123 patients1 treated in TakeAim Leukemia Ph 1/2 study, acceptable safety profile established ❷ Demonstrate single-agent activity Single-agent activity observed; next step is to confirm these initial findings in a larger number of patients ❸ Pursue fastest path t
Slide 27: Single-agent activity demonstrated in AML
Single-agent activity demonstrated in AML Patients treated at 300mg BID All Patients, All Dose Levels who also have FLT3 mutation 100% 100% 80% 80% 60% Before enriching 60% 6 of 11 evaluable patients for Optimal Dose & FLT3m achieved objective response 40% 40% 20% 20% Enrich for 0% 0% Dose & FLT3m -
Slide 28: Strategy in AML
Strategy in AML ❶ Demonstrate safety 123 patients1 treated in TakeAim Leukemia Ph 1/2 study, acceptable safety profile established ❷ Demonstrate single-agent activity Single-agent activity observed; next step is to confirm these initial findings in a larger number of patients ❸ Pursue fastest path t
Slide 29: Emavusertib in FLT3m AML
Emavusertib in FLT3m AML fo CUMS’
Slide 30: Emavusertib's dual-targeting of IRAK4 and FLT3 enables monotherapy opportunity in FLT3m AML
Emavusertib’s dual-targeting of IRAK4 and FLT3 enables monotherapy opportunity in FLT3m AML IRAKi synergy with FLT3i 100% – 75% – FLT3i Control IRAK4 inhibition overcomes adaptive resistance 50% – IRAKi to FLT3i 25% – Concomitant targeting of IRAK1 or IRAK4, alongside FLT3, is the most effective mea
Slide 31: Emavusertib is a potential best-in-class therapy in FLT3m AML
Emavusertib is a potential best-in-class therapy in FLT3m AML CR/CRh/CRi Rate 35% Salvage Line Patients 30% treated with emavusertib achieved > 30% CR/CRh rate 25% Benchmark ~1.5X greater than the benchmark in FLT3i-naïve patients is for FLT3i-naïve patients 20% 21% CR/CRh rate 15% 87% of patients i
Slide 32: Encouraging updated data in FLT3m AML
Encouraging updated data in FLT3m AML presented at ASCO/EHA 2024 Duration on Treatment CR CR MLFS went to SCT CR → went to SCT ongoing CRh → 6 of 11 evaluable patients achieved objective response ongoing MLFS → ongoing → ongoing → Not Evaluable Days on Treatment 0 days 50 100 150 200 250 300 Source:
Slide 33: Strategy in AML
Strategy in AML ❶ Demonstrate safety 123 patients1 treated in TakeAim Leukemia Ph 1/2 study, acceptable safety profile established ❷ Demonstrate single-agent activity Single-agent activity observed; next step is to confirm these initial findings in a larger number of patients ❸ Pursue fastest path t
Slide 34: Emavusertib in All Comers
Emavusertib in All Comers fo CUMS’
Slide 35: Emavusertib combination with aza/ven targets all comers in frontline AML
Emavusertib combination with aza/ven targets all comers in frontline AML oncogenic IRAK4-L is expressed emavusertib synergy with aza/ven ema/aza/ven in nearly all AML patients in preclinical studies triplet combination 800 Preclinical Data All Comers Model Relative cell growth in AML cell lines (THP
Slide 36: Summary in AML
Summary in AML Leukemia • Emavusertib targets both FLT3 and IRAK4 • Emavusertib offers potential for best-in-class therapeutic in FLT3m AML (a genetically-defined population) • Oncogenic IRAK4 is expressed in nearly all AML patients and is not addressed by current standard-of-care (azacitidine and v
Slide 37: Solid Tumors
Solid Tumors fo CUMS’
Slide 38: Ongoing studies (ISTs) of emavusertib in Solid Tumors
Ongoing studies (ISTs) of emavusertib in Solid Tumors Tumor Type Institution (Investigator) Emavusertib Combination Partner Pancreatic CRADA Washington University (Grierson, Lim) gemcitabine, nab-paclitaxel CRADA Oklahoma University (Ulahannan) Colorectal FOLFOX, bevacizumab Washington University (L
Slide 39: Other Information
Other Information fo CUMS’
Slide 40: Financials and IP
Financials and IP We believe cash is sufficient to achieve anticipated near-term milestones As of September 30, 2024 1 • Data in ~20 pts in R/R FLT3m AML (ASH 2024) $31.6M Cash and Investments • Updated PCNSL data in ~15-20 patients (1Q25) ~8.5M Shares Outstanding • AML triplet initial safety data (
Slide 41: End of Presentation
End of Presentation fo CUMS’