Rain Enhancement Technologies Holdco, Inc. · NASDAQ:RAIN
Rain Enhancement Technologies Holdco — Rain Oncology — Investor Presentation (February 2023)
23 slides from Rain Enhancement Technologies Holdco's investor presentation, Feb 9, 2023
Slide 1: Corporate Presentation – Feb 2023
Rain Oncology Inc. C O R P O R AT E P R E S E N TAT I O N – F e b 2 0 2 3
Slide 2: Forward Looking Statements
R A I N O N C O L O G Y I N C . 2 Forward Looking Statements This presentation contains “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. Other than statement
Slide 3: Rain's Corporate Leadership
R A I N O N C O L O G Y I N C . 3 Rain’s Corporate Leadership Robert Doebele, MD, PhD Cofounder, President & Chief Scientific Officer Richard Bryce, MBChB Executive VP & Chief Medical Officer Vijaya Tirunagaru, PhD Senior VP, Head of Research Mehdi Paborji, PhD Senior VP, Head of Technical Operation
Slide 4: Rain Oncology Overview
R A I N O N C O L O G Y I N C . 4 Rain Oncology Overview Milademetan (RAIN-32), an oral inhibitor of the p53-MDM2 complex, represents a “pipeline in a program” ATTRACTIVENESS OF REGULATING P53-MDM2 COMPLEX Loss of the transcription factor p53 can facilitate tumor growth, with elevated levels of MDM2
Slide 5: p53-MDM2 Axis & Milademetan MoA
R A I N O N C O L O G Y I N C . 5 p53-MDM2 Axis & Milademetan MoA Source: Rain Oncology Wildtype p53 responds to normal cellular injury to protect against cancer via induction of cellular apoptosis or senescence • Mutated p53 incapable of target gene binding and function Dysregulated MDM2 can facili
Slide 6: Rain anticipated clinical studies
R A I N O N C O L O G Y I N C . 6 Rain anticipated clinical studies Rain Oncology: Overview With proforma cash of $147 million*, and a cash runway into 2025, Rain is well-financed to complete several trials for milademetan, including the phase 3 registrational study in liposarcoma INDICATION MANTRA
Slide 7: Milademetan (Liposarcoma)
Milademetan ( L i p o s a r c o m a )
Slide 8: Liposarcoma Overview
R A I N O N C O L O G Y I N C . 8 Drug Company Approved Mechanism Efficacy in DD LPS (mPFS) 2015 DNA binding / alkylator 2.2 mo8 2016 Microtubule targeting 2.0 mo9 Liposarcoma Overview PFS is the primary outcome measured in most sarcomas DDLS WDLS T O T A L A D D R E S S A B L E M A R K E T A P P R
Slide 9: Phase 3 Registrational Trial
R A I N O N C O L O G Y I N C . 9 Phase 3 Registrational Trial • 72 sites • US, Europe, Asia Patient Enrollment • Commenced July 2021 • Closed July 2022 • N = 175 Unresectable or metastatic DD liposarcoma* Milademetan 260mg QD 3/14 Trabectedin 1.5 mg/m2 as 24-hour IV infusion D1 Q3W Stratification:
Slide 10: Milademetan Phase 1 (U101) Trial Select Treatment Emergent Adverse Events
R A I N O N C O L O G Y I N C . 1 0 Milademetan Phase 1 (U101) Trial Select Treatment Emergent Adverse Events Organ Class n (%) Schedule A, B, and C Cohorts (n=78) Schedule D All doses (n=29) All Grades Grade ≥ 3 All Grades Grade ≥ 3 All drug-related TEAEs 74 (95) 43 (55) 25 (86) 5 (17) Blood and ly
Slide 11: Milademetan Phase 1 (U101) Study Observed Progression-Free Survival
R A I N O N C O L O G Y I N C . 1 1 Milademetan Phase 1 (U101) Study Observed Progression-Free Survival C O R P O R A T E P R E S E N T A T I O N A l l P a t i e n t s ( n = 1 0 7 ) Source: Gounder et al., 2023 JCO DD LPS Non-LPS D D L P S P a t i e n t s ( n = 5 3 ) Treatment naive Relapsed Treatme
Slide 12: Milademetan Phase 1 (U101) Study: Schedule D 260mg
R A I N O N C O L O G Y I N C . 1 2 Milademetan Phase 1 (U101) Study Of the four (4) dose schedules evaluated, Schedule D (QD 3/14), 260mg was identified to have the most favorable efficacy / safety profile, and to serve as the basis of milademetan dosing in subsequent studies C O R P O R A T E P R
Slide 13: Milademetan Phase 2 MANTRA-2 (MDM2 Amp Basket)
Milademetan P h a s e 2 M A N T R A - 2 ( M D M 2 A m p B a s ke t )
Slide 14: MDM2 Amplified Solid Tumors: Rationale
R A I N O N C O L O G Y I N C . 1 4 M D M 2 A M P C O N F E R S P O O R P R O G N O S I S E L I G I B L E M D M 2 A M P P A T I E N T S ( C N ≥ 8 ) Total cases Number deceased Median OS (Months) MDM2 CN<8 6072 1514 117.8 MDM2 CN≥8 126 54 49 MDM2 CN < 8 MDM2 CN ≥ 8 Log-rank test P<0.0001 MDM2 Amplifi
Slide 15: Milademetan MDM2 Amplified, WT TP53 Advanced Solid Tumors
R A I N O N C O L O G Y I N C . 1 5 Milademetan 260mg QD 3/14 MDM2 Amplified, WT TP53 Advanced Solid Tumors (copy number ≥ 8) • Selecting patients with MDM2 gene copy number (CN) of ≥ 8 • Of 17 patients enrolled, 15 have received first dose of milademetan1 ‒ Of 15 patients receiving at least one dos
Slide 16: Interim MANTRA-2 Analysis: Patient Outcomes
R A I N O N C O L O G Y I N C . 1 6 Patient Tumor Diameter Change Interim MANTRA-2 Analysis: Patient Outcomes Two (2) Partial Responses and two (2) near-PRs observed of 10 evaluable patients 25% 5% 0% -4% -7% -27% -29% -30% -34% -40% -30% -20% -10% 0% 10% 20% 30% NSCLC EGFR del19 KRAS G12D Pancreati
Slide 17: Interim MANTRA-2 Analysis: Duration on Therapy
R A I N O N C O L O G Y I N C . 1 7 0 8 16 24 32 40 3202-1010-012 3202-1010-007 3202-1006-010 3202-1006-014 3202-1006-013 3202-1006-011 3202-1006-005 3202-1003-009 3202-1010-004 3202-1010-003 1 Interim MANTRA-2 Analysis: Duration on Therapy Two (2) Partial Responses and two (2) near-PRs observed of
Slide 18: Milademetan Phase 2 MANTRA-4 (CDKN2A Loss/WT p53 Basket)
Milademetan P h a s e 1 / 2 M A N T R A - 4 ( C D K N 2 A L o s s / W T p 5 3 B a s ke t )
Slide 19: MANTRA-4: IO Combo in CDKN2A Loss, p53 WT Adv Solid Tumors
R A I N O N C O L O G Y I N C . 1 9 Error bars represent Median with 95% CI MDM2 CN >12 * Homozygous CDKN2A loss MANTRA-4: IO Combo in CDKN2A Loss, p53 WT Adv Solid Tumors In the US, there are an estimated 45,000 patients1 annually with advanced cancers exhibiting p53 WT and CDKN2A loss Normal Cance
Slide 20: MANTRA-4 Trial Design
R A I N T H E R A P E U T I C S 2 0 DLT, dose-limiting toxicity; RP2D, recommended Phase 2 dose. 1 Subject to subsequent discussions with Roche and outcome of the Phase 1 safety study. DOSE LEVEL DOSE LEVEL Evaluate efficacy, safety and tolerability in patients with CDKN2A loss, p53 WT advanced soli
Slide 21: Key Takeaways and Anticipated Milestones
R A I N O N C O L O G Y I N C . 2 1 Key Takeaways and Anticipated Milestones Up to 50% of cancers with WT p53 targetable either via monotherapy or combination strategies MDM2 amp (MANTRA-2): Enrolling CDKN2A loss (MANTRA-4): Commencing in mid 2023 Exploring activity of milademetan in adv solid tumor
Slide 22: Appendix
Appendix
Slide 23: Rain's Corporate Governance
R A I N O N C O L O G Y I N C . 2 3 Rain’s Corporate Governance Avanish Vellanki, MBA Chairman & CEO, Rain Oncology Aaron Davis, MBA CEO, Boxer Capital Gorjan Hrustanovic, PhD Managing Director, BVF LP Peter Radovich, MBA COO, Mirum Franklin Berger, CFA FMB Research Tran Nguyen, MBA CFO & COO, Proth
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