Traws Pharma, Inc. · NASDAQ:TRAW
Traws Pharma — Investor Presentation (June 2025)
24 slides from Traws Pharma's investor presentation, Jun 3, 2025
Slide 1: Traws Pharma Narazaciclib June 2025
Traws Pharma Narazaciclib June 2025
Slide 2: Forward-looking statements
Forward - looking statements This presentation contains, and certain oral statements made by management from time to time may contain, “forward - looking state ments” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securi
Slide 3: Narazaciclib: Advancing Beyond Existing CDK4/6 to Overcome Resistance
• Multi - targeted approach: Narazaciclib inhibits CDK4/6 and other clinically validated cyclin - dependent kinases • AMPK - related protein kinase 5 (ARK5), • Colony - stimulating factor 1 receptor (CSF1R), • Designed for resistance: By targeting CSF - 1 and FGFR, Narazaciclib is positioned to over
Slide 4: Narazaciclib Clinical Studies
Study Status Phase 3 Phase 2 Phase 1 Indication Program ISS with Icahn School of Medicine, Mount Sinai (MSSM), NY, USA Currently on hold, pending funding. Metastatic Hormone receptor+ breast cancer who have failed frontline CDK 4/6 inhibitors Narazaciclib +fulvestrant or exemestane Oral ISS with Ica
Slide 5: Unmet Needs in HR+/HER2- Metastatic Breast Cancer
Unmet Needs in HR+/HER2 - Metastatic Breast Cancer • Median overall survival with CDK4/6 inhibitors ~5 years; MBC remains incurable • High rates of discontinuation due to AEs Limited Long - Term Benefit of Current Therapies & Toxicity Challenges • Most patients progress on CDK4/6 + endocrine therapy
Slide 6: Current Therapies Show Limited Efficacy with Challenging-to-Manage Toxicities
Current Therapies Show Limited Efficacy with Challenging - to - Manage Toxicities Notes Safety Efficacy Therapeutic Approach Studies are small 30% AE discontinuation due to everolimus 4 - 7 month PFS Everolimus combinations SERDs (elacestrant, fulvestrant) are agents studied; elacestrant had PFS of
Slide 7: Large Population CDK4/6 Resistant Patients in Need of Novel Therapy in 2L mBC
Large Population CDK4/6 Resistant Patients in Need of Novel Therapy in 2L mBC Rationale/Source Eligible for Novel Post - CDK4/6 Treatment Number of Patients Patient Population 700,000 BC Incidence SEER, WHO 490,000 70% HR+/HER2 - • Prevalence, clinicopathologic features and long - term overall survi
Slide 8: Opportunity for Innovation in HR+/HER2- mBC Post-CDK4/6 Progression
Opportunity for Innovation in HR+/HER2 - mBC Post - CDK4/6 Progression • Significant unmet need in patients progressing after initial CDK4/6 inhibitor therapy • Limited long - term benefit • Challenging to Manage Tox Profiles • Resistance is inevitable • Few effective post - progression options Nara
Slide 9: Narazaciclib Targets Key Kinases vs Other CDK4/6s
Narazaciclib Targets Key Kinases vs Other CDK4/6s Importance of CSF1R and ARK5/NUAK1 9 ARK5: • ARK5 is a member of the AMPK family. • Plays a role in: • Cell survival under metabolic stress • Epithelial - mesenchymal transition (EMT) • Metastasis • Resistance to apoptosis Relevance in Breast Cancer:
Slide 10: Potency of Narazaciclib vs other CDK4/6
Potency of Narazaciclib vs other CDK4/6 Narazaciclib is a best - in - class CDK4/6 with potency against critical kinases that other CDKs do not target 10 Reaction Biology 2021; Data on file. *Note that kinase activity is based on nM IC 50 values, a quantitative measure indicating the concentration n
Slide 11: Narazaciclib Inhibits Growth of Palbociclib Resistant Cancer Cell Lines
Narazaciclib Inhibits Growth of Palbociclib Resistant Cancer Cell Lines Prostate Cancer Cells Ovarian Cancer Cells Palbociclib Palbociclib Palbociclib Narazaciclib Narazaciclib Narazaciclib Breast Cancer Cells Breast cancer cells = MDA - MB - 468; Ovarian cancer cells = 2008 cells; Prostate Cancer c
Slide 12: Preclinical Results Show Reduced Neutropenia with Narazaciclib Compared to Palbociclib
Preclinical Results Show Reduced Neutropenia with Narazaciclib (ON123300) Compared to Palbociclib Xenograft Mice (n=5/group) B ON 123300, an Orally Administered Novel CDK4/6 + ARK5 Inhibitor, Exhibits Potent Antitumor Activity In Vivo: Comparative Studies with Palbociclib S. Patel* 1 , P. Pancholi 1
Slide 13: Narazaciclib: Phase Development Plan to Identify RP2D
Narazaciclib: Phase 1 Development Plan to Identify RP2D Status / Topline Result Primary Endpoints Objective Study Enrollment completed in dose escalation phase; RP2D as monotherapy, not yet achieved Patients dosed up to 280mg Assess Pharmacokinetics, pharmacodynamics, lab abnormalities, dose limitin
Slide 14: Narazaciclib: Early Signs of Promising Activity in Monotherapy
Narazaciclib: Early Signs of Promising Activity in Monotherapy With Some Patients Benefiting Beyond 1 year 14 Changes in Target Tumor Size - Waterfall Plot 4 pts achieved SD, no CR/PR, encouraging SD • 1 SD at 80mg: Gastrointestinal stromal tumor, GIST, SD for 63 days • 1 SD at 120 mg: Breast cancer
Slide 15: Narazaciclib: Differentiated CDK4/6+ Inhibitor with Broad Potential in Oncology
Narazaciclib: Differentiated CDK4/6+ Inhibitor with Broad Potential in Oncology 15 • In vitro activity against several high potential kinase targets including CDK4/6, ARK5/ NUAK 1 and CSF1R • Preclinical data point to a role in resistant disease and show synergy with immunotherapies • Opportunities
Slide 16: RGT-419B Regor Therapeutics CDK4+ Phase Data
RGT - 419B Regor Therapeutics CDK 4+ Phase 1 Data 1. Roche Pharma Day Presentation 2024 pharma_day_20240930_final_online_v02.pdf (roche.com) 16 • Phase 1 Study results presented at San Antonio in 2023 and updated by Roche on Pharma - Day. 1 • Included 12 patients with HR+HER2 - Advanced Breast Cance
Slide 17: RGT-419B Regor Therapeutics CDK4+
RGT - 419B Regor Therapeutics CDK4 • RGT - 419B, a CDK 4+ inhibitor developed by Regor Therapeutics was recently licensed out to Roche who paid $850 Million upfront in October 2024 1 • Comparable CDK 4/6 activity to Narazaciclib but RGT - 419B also inhibits CDK2 • Unlike Narazaciclib RGT - 419B does
Slide 18: Narazaciclib is a Promising CDK4/6 Inhibitor with Broad Potential in Oncology
Narazaciclib is a Promising CDK4/6 Inhibitor with Broad Potential in Oncology 18 • Three Phase 1 monotherapy and combination studies in patients with advanced cancer, including studies completed by Traws and partner HanX (greater China), established a recommended Phase 2 dose (RP2D) • In vitro activ
Slide 19: Appendix
Appendix TFRAWS PHARMA
Slide 20: Narazaciclib is more than a CDK4/6 inhibitor
Narazaciclib is more than a CDK4/6 inhibitor • TNBC, NSCLC , Melanoma and CRC with DNA mismatch repair (MSI - H/dMMR) are all treated with pembrolizumab and other ICB therapies; however, a large number of patients exposed to ICB do poorly with treatment 1 • The tumor immune microenvironment (TIME) h
Slide 21: Tumor Associated Macrophages (TAMs): Key drivers of resistance in the TIME
Tumor Associated Macrophages (TAMS): Key drivers of resistance in the TIME CSF - 1R is a critical growth factor for TAMS; CSF - 1R inhibition results in depletion of TAMS Li Y, Wang R, Gao Q. The Roles and Targeting of Tumor - Associated Macrophages. Front Biosci (Landmark Ed). 2023 Sep 15;28(9):207
Slide 22: Colony-Stimulating Factor-Antibody Reverses Chemoresistance in MCF-7 Xenografts
Colony - Stimulating Factor - 1 Antibody Reverses Chemoresistance in Human MCF - 7 (ER positive) Breast Cancer Xenografts Cancer Res. 2006;66(8):4349 - 4356. doi:10.1158/0008 - 5472.CAN - 05 - 3523 22
Slide 23: Narazaciclib in combination with anti-mPD1 is effective in TNBC in vivo
Narazaciclib in combination with anti - mPD1 is effective in TNBC in vivo 23 Body Weight Tumor Volume Tumor Weight (Day 22) Vehicle Anti - mPD1 ON123300 Combo Individual Tumor Weights: Median and Range Performed at Reaction Biology, Germany
Slide 24: Comparison of Narazaciclib and Abemaciclib With IC50 Values Below 30 nM
Comparison of Narazaciclib and Abemaciclib With IC50 Values Below 30 nM Narazaciclib IC 50 Values Below 30 nM Traws Pharma Data on File Abemaciclib Narazaciclib KINASE 308 0.7 CSF1R (C - FMS) 0.6 0.6 CDK6/cyclin D1 10 0.9 CDK6/cyclin D2 10 0.9 CDK6/cyclin D3 0.8 2 CDK4/cyclin D1 1 3 CDK4/cyclin D2 2