Nuvectis Pharma, Inc. · NASDAQ:NVCT
Nuvectis Pharma — IPO Roadshow (January 2022)
22 slides from Nuvectis Pharma's IPO roadshow presentation, Jan 18, 2022
Slide 1: Innovative Precision Medicine for Serious Conditions of Unmet Medical Need in Oncology
1 SEPTEMBER 2021 Innovative Precision - Medicine for Serious Conditions Of Unmet Medical Need in Oncology JANUARY 2022 Innovative Precision Medicine for Serious Conditions Of Unmet Medical Need in Oncology Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Number 333 - 260099
Slide 2: Forward-Looking Statements
Forward - Looking Statements Certain statements in this presentation constitute “forward - looking statements” within the meaning of Section 27 A of the Securities Act of 1933 and Section 21 E of the Securities Exchange Act of 1934 , each as amended . Statements other than those of historical fact,
Slide 3: Offering and registration statement notice
This presentation highlights basic information about us and the proposed offering. Because it is a summary, it does not contain all of the information that you should consider before investing. The Company has filed with the U.S. Securities and Exchange Commission (the “SEC”) a registration statemen
Slide 4: Key Highlights
4 Innovative Precision Medicine for Serious Conditions of Unmet Medical Needs in Oncology Key Highlights • Management team with proven track record of clinical and regulatory success and significant shareholder value creation • Novel pipeline of precision targeted therapy drug candidates • NXP800: A
Slide 5: Nuvectis Pipeline
Nuvectis Pipeline 5 Unique precision - medicine drug candidates Preclinical / IND - Enabling Phase 1a Dose Escalation (Advanced Solid Tumors) Phase 1b Cohort Expansion (Target Indications) Phase 2 Phase 3 Ovarian Clear Cell Carcinoma (OCCC) Endometrioid Ovarian Carcinoma ARID1a mutation + Adv. Solid
Slide 6: Leadership Team Track Record of Success
Leadership Team Track Record of Success Ron Bentsur CHAIRMAN AND CEO has over 20 years of senior leadership experience in the biopharmaceutical industry: CEO of UroGen Pharma, (NASDAQ : URGN), CEO of Keryx Biopharmaceuticals, (NASDAQ:KERX, acquired by Akebia Therapeutics). Mr. Bentsur served on the
Slide 7: Leadership Team (cont.)
Leadership Team (cont.) Track Record of Success 7 2 Breakthrough Therapy Designations in oncology. Multiple Orphan Drug Designation (US/EU) and Fast Track Designations (US) Team Achievements 4 FDA approvals 2 EU approvals 1 approval in Japan (via partner) Proven significant shareholder value creatio
Slide 8: NXP800 A Novel HSF1-Pathway Inhibitor
NXP800 A Novel HSF1 - Pathway Inhibitor 8 About NXP800 • Key Highlights • Development Strategy • Scientific Background • HSF1 Pathway • In Vivo Proof Of Concept • ARID1a • Addressable Patient Population
Slide 9: NXP800 Key Highlights
NXP800 Key Highlights Discovered and optimized at the Institute of Cancer Research (ICR) in the UK. The ICR discovered Zytiga, a leading drug for metastatic prostate cancer. Unique, novel molecule targeting a well - characterized biologic pathway with established relevance in oncology: Heat Shock Fa
Slide 10: NXP800 Clinical Development Plan
NXP800 Clinical Development Plan Phase 1a (Commenced in December 2021) • Accelerated dose escalation (i.e., begin with single - patient cohorts) • 5 - 7 dose levels planned • Objectives: Evaluation of safety and tolerability, and recommendation of dose and dosing schedule for Phase 1b Phase 1b • OCC
Slide 11: Targeting the HSF1 Pathway in Oncology
Targeting the HSF1 Pathway in Oncology Adapted from Dong 2019 . Inhibiting Heat Shock Factor 1 in Cancer: A Unique Therapeutic Opportunity . Trends in Pharmacological Sciences. HSF1 pathway addiction – enables cancer cells to overcome diverse stresses and promote biological activities crucial for ca
Slide 12: NXP800 Demonstrated Substantial Antitumor Activity in OCCC Xenografts
NXP800 Demonstrated Substantial Antitumor Activity in OCCC Xenografts with the ARID1a Mutation 12 Model 1: SKOV - 3 Model 2: TOV - 21G NXP800 35 mg/kg po daily NXP800 35 mg/kg po 5/7 days
Slide 13: OCCC and Endometrioid Ovarian Cancer
OCCC and endometrioid Ovarian Cancer 13 Ovarian Cancer Net Incidence by Type 10% 10% OCCC endometrioid Ovarian Clear Cell Carcinoma (OCCC): • US: 10% of ovarian cancer cases (~2,175 new patients/year). • ~2/3 of OCCC patients have an ARID1a mutation. Endometrioid ovarian cancer: • US: ~10% of ovaria
Slide 14: ARID1a Mutation Patient-Selection Strategy
ARID1a Mutation Patient - selection strategy 14 Indication Estimated Incidence (US) Estimated Number of Patients with ARID1a protein loss (US) Ovarian Clear Cell Carcinoma 2,175 1,410 Endometrioid Carcinoma 2,175 909 Uterine endometrioid 66,570 26,628 Urothelial 75,357 25,621 Hepatocellular 34,000 9
Slide 15: NXP900 A Novel SRC/YES1 Inhibitor
NXP900 A Novel SRC / YES1 inhibitor 15 About NXP900 • Key Highlights • Introduction to NXP900 • SRC/YES1 signaling • Unique Mechanism of Action • In Vivo Proof of Concept • Opportunity in Solid Tumors
Slide 16: NXP900 Key Highlights
NXP900 Key Highlights 16 NXP900 is clearly differentiated from other SRC inhibitors, due to: • Unique MoA providing for the complete shutdown of the SRC signaling pathway • High selectivity without immune suppression effect IND - enabling studies ongoing; IND / CTA filing planned for 2H2022. Novel,
Slide 17: SRC/YES1 Kinase Signaling
17 SRC / YES1 Kinase Signaling SRC - mediated signal transduction involves catalytic and scaffolding elements Catalytic Domain SRC kinase family members (such as Src and Yes1) transmit pro - oncogenic signals via phosphorylation of downstream targets Scaffold Domain SH2 and SH3 domains of SRC kinase
Slide 18: NXP900 Novel and Differentiated Mechanism of Action
18 NXP900 Novel and Differentiated Mechanism of Action Closed conformation locked by NXP900 No inhibitor Fully active SRC Other multi - kinase inhibitors Partial shutdown of the SRC pathway NXP900 Complete shutdown of the SRC pathway Open conformation no inhibitor Open conformation stabilized by oth
Slide 19: NXP900 Superior Preclinical Activity vs. Approved Compound
19 NXP900 Superior Preclinical Activity vs. Approved Compound NXP900 inhibited tumor growth in an orthotopic model of triple negative breast cancer (TNBC) in immunocompetent animals, showing superiority vs dasatinib, and substantial long - term effect after treatment completion. A,B) Comparative ana
Slide 20: NXP900 Addresses the Shortcomings of Other SRC Inhibitors
NXP900 Addresses the Shortcomings of Other SRC Inhibitors 20 NXP900 provides an opportunity to treat solid tumors with a SRC inhibitor SRC overactivation is implicated in several solid tumors. However, the existing multi - kinase SRC inhibitors, including dasatinib, which is approved for CML/ALL, ha
Slide 21: Nuvectis Pharma Key Milestones
21 Nuvectis Pharma Key Milestones KEY MILESTONES NXP900 IND - enabling studies initiated in 4Q2021 NXP800 Phase I initiated in 4Q2021 Preclinical updates and publications expected throughout 2022 for both NXP800 and NXP900 NXP800 Phase 1a updates throughout 2022 NXP900 IND/CTA filing in 2H2022 NXP80
Slide 22: Key Highlights
22 Precision Medicine Innovation for Serious Conditions of Unmet Medical Needs in Oncology Key Highlights • Management team with a proven track record of clinical and regulatory success • 4 FDA approvals • 2 EU and 1 Japanese (via partner) approvals • Significant shareholder value creation • Unique