Traws Pharma, Inc. · NASDAQ:TRAW
Traws Pharma — Investor Presentation (April 2024)
37 slides from Traws Pharma's investor presentation, Apr 16, 2024
Slide 1: Potential best in class product candidates for cancer & respiratory viral diseases
Potential best in class p roduct candidates in development for cancer & respiratory viral diseases April 2024 NASDAQ - TRAW
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: Traws Pharma – A clinical stage biopharmaceutical company
Closing cash balance of approximately $30.3 million as of April 3, 2024 from Onconova funds and concurrent private placement led by OrbiMed and Torrey Pines. TRX01 ( t ravatrelvir ) – Covid 19: Phase 1 clinical data and initiation of phase 2 H2 2024 TRX100 ( v iroxavir ) – Influenza: Phase 1 clinica
Slide 4: Experienced Leadership Team
TRAWS PHARMA – Experienced Leadership Team Steven Fruchtman , M.D. President & CSO Oncology Robert R. Redfield, MD Chief Medical Officer C. David Pauza , PhD CSO Virology Nikolay Savchuk , PhD Chief Operating Officer Werner Cautreels , PhD Chief Executive Officer Mark Guerin Chief Financial Officer
Slide 5: Accomplished Board of Directors
TRAWS PHARMA – Accomplished Board of Directors James D. Marino DIRECTOR Management Scientific Advisory Board Jack E. Stover DIRECTOR Iain Dukes EXECUTIVE CHAIRMAN Nikolay Savchuk DIRECTOR Trafford Clarke DIRECTOR Werner Cautreels DIRECTOR Teresa Shoemaker DIRECTOR 5
Slide 6: Pipeline Overview
Target Indication Preclinical Phase 1/2 Phase 2/3 Narazaciclib (DAILY) Solid tumors Narazaciclib + Letrozole (BOTH DAILY) 2L / 3L Low grade endometrioid endometrial cancer Rigosertib Epidermolysis bullosa - associated squamous cell carcinoma (rare disease) Virology Programs Target Indication Preclin
Slide 7: Virology: Mpro Inhibitor (COVID) TRX01 - travatrelvir
Virology: Endonuclease Inhibitor (Influenza) Mpro Inhibitor (COVID) TRX01 - travatrelvir
Slide 8: Challenges and Opportunities for COVID19
Challenges and Opportunities for COVID19 • COVID19 remains among the top 5 causes of death in the developing world. The [ nirmaltrevir +ritonavir] course is 5 days BID; drug:drug interactions limit eligibility and use in many patients (Corritori, 2022, COVID). • 20.8% of [ nirmaltrevir + ritonavir]
Slide 9: TRX01 (travatrelvir) - Investigational Candidate
• Improved potency over nirmatrelvir (up to 9 times more potent in biochemical and cell - based assays); potency advantages greatest among Omicron strains and current VOC • Does not require co - administered CYP inhibitor • Exposures >EC90 for >48 h after single oral dose in animals • GLP toxicology
Slide 10: TRX01 Superior to nirmatrelvir against Omicron Variants
Virus m.o.i . TRX01 EC50 nM Nirmatrelvir EC50 nM Remdesivir EC50 µM Nirmatrelvir EC50 ÷ TRX01 EC50 USA_WA1/2020 0.005 2.6 11 1.7 4.2 Omicron B.1.1.529 0.02 16 26 0.69 1.6 Omicron B.A.2 0.01 7.3 21 0.74 2.9 Omicron B.A.4 0.02 <1 <1 1.2 - Omicron B.A.5 0.02 <1 <1 2.5 - Omicron BF.7 0.003 4.7 41 1.8 8.
Slide 11: TRX01 Phase 1 Study Plan
A Randomized, Double - Blind, Placebo - Controlled, First - in - Man Study of Orally Administered travatrelvir to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of Single and Multiple Ascending Doses in Healthy Volunteers TRX01 ( travatrelvir ) - Phase 1 Study Plan Single (A
Slide 12: TRX01 Phase 2 development
• Phase 1 will provide data on safety and tolerability of a 10 - day, daily regimen • Phase 1 data will guide design of the phase 2 development plan • Phase 2 is anticipated to be an international, multi - center randomized, double - blind, controlled clinical trial of the efficacy and safety of tra
Slide 13: TRX01 (travatrelvir) - Summary
• P otent inhibitor of SARS - CoV - 2 Mpro (3CL protease) • Active in vitro against original, delta and omicron variants of SARS - CoV - 2 • More potent than nirmatrelvir; does not require ritonavir co - administration in preclinical studies and therefore expected to avoid drug:drug interactions pot
Slide 14: Virology: Endonuclease Inhibitor (Influenza) TRX100 - viroxavir
Virology: Endonuclease Inhibitor (Influenza) Cap - dependent Endonuclease Inhibitor (Influenza) TRX100 - viroxavir
Slide 15: Challenges and Opportunities for Influenza Therapy
Challenges and Opportunities for Influenza Therapy • New drugs are needed to treat influenza strains resistant to oseltamivir or baloxavir • Long - acting antiviral drugs will increase influenza resistance among elderly and immunocompromised populations • The ongoing risk from virus emerging out of
Slide 16: TRX100 (viroxavir) - Investigational Candidate
TRX100 ( viroxavir ) - Investigational Candidate Cap - Dependent Endonuclease (CEN) Inhibitor for Influenza 16 The oral prodrug viroxavir targets the cap - dependent endonuclease of Influenza and is a potent inhibitor of influenza virus replication including A or B strains I nhibits pandemic - poten
Slide 17: TRX101: The active metabolite of viroxavir
TRX101: The active metabolite of viroxavir , in cell - based assays 17 TRX101 (the active metabolite of the prodrug v iroxavir ) was potent at nM concentrations for inhibiting wild - type and baloxavir resistant viral replicase complexes TRX101 is a potent inhibitor of influenza virus replication in
Slide 18: TRX101 inhibition of baloxavir-resistant influenza A replication
TRX101 - potent inhibition of baloxavir - resistant influenza A virus replication TRX - 101 inhibits replication of influenza A/California/04/2009(H1N1)pdm09 and A/Texas/71/2017(H3N2) viruses containing PA I38 - WT, I38T, or I38M substitutions TRX - 101 was more potent than BXA for inhibiting replica
Slide 19: TRX100 Summary of Available Phase 1 Clinical Data
TRX100 ( viroxavir ) - Summary of Available Phase 1 Clinical Data • Healthy Caucasian men 18 - 45 years, single ascending dose, 20, 40 80 or 120 mg on empty stomach followed by 8 - 15 days washout before receiving the same dose after a meal. • Study confirmed high exposure and long - half life after
Slide 20: TRX100 Phase 1 Dose Extension Study
TRX100 ( viroxavir ) - Phase 1 Study – Acute Influenza Dose Extension Study – to start H1 2024 * Repeats highest dose cohort from previous Phase 1 study A single ascending dose, placebo - controlled study on safety and tolerability of viroxavir in healthy volunteers. This study tests a 200 mg dose l
Slide 21: TRX100 Phase 2 development
• Phase 1 data will define further design of the phase 2 development plan • Phase 2 is planned to be an international multicenter randomized, double - blind, controlled clinical trial of the efficacy and safety of viroxavir in patients with Influenza • Potentially as a single oral administration • P
Slide 22: TRX100 (viroxavir) - Summary
TRX100 ( viroxavir ) - Summary 22 • Potent at nM or sub - nanomolar concentrations against a panel of influenza A and influenza B viruses including highly pathogenic avian influenza strains circulating in 2022 • Demonstrated in animals preferential accumulation in lung, which may improve antiviral p
Slide 23: Narazaciclib - Oncology
arazacicli ONCOLOGY
Slide 24: CDK 4/6 Inhibitors Represent an Important Class of Cancer Therapeutics
CDK 4/6 Inhibitors Represent an Important Class of Cancer Therapeutics Graphic: San Antonio Breast Cancer Symposium, 2023 Poster • Overexpression of CDK 4/6 causes cell - cycle deregulation in certain cancers • Role of Rb pathway in tumor initiation and progression is well - established • Inhibition
Slide 25: Narazaciclib Differentiation in Preclinical Studies
Narazaciclib has Demonstrated Differentiation in Preclinical Studies Active in numerous tumor types in preclinical results with acceptable and differentiated safety profile • Narazaciclib causes less myelosuppression and, thus less neutropenia A potent inhibitor of CSF1R • CSF1 promotes the infiltra
Slide 26: Recurrent Metastatic Low-grade Endometrioid Endometrial Cancer: High Unmet Need
Recurrent Metastatic Low - grade Endometrioid Endometrial Cancer (LGEEC) is an Area of High Unmet Need Improved treatment options are needed for patients failing first - line therapy Phase 1, Dose Escalation/Dose Finding (MTD/RP2D), Safety, Tolerability, PK, PD; Dose Expansion; 3+3 design Completed
Slide 27: Narazaciclib Phase 1 Single Agent in Solid Tumors
Narazaciclib Phase 1: Study 19 - 01 Single Agent in Solid Tumors VISIT 001 - 015 001 - 016 001 - 017 002 - 015 002 - 017 005 - 009 Tumor type Ovarian Oropharynx SCC Pancreatic NSCLC SCC LGSOC Screening (Day - 14 to - 1) 82 79 82 155 126 79 Cycle 1 Day 1 70 54 73 129 152 85 Cycle 1 Day 8 <50 52 52 59
Slide 28: In Vitro Multi-Kinase Activity with nM Potency
In Vitro Multi - Kinase Activity with nM Potency for the CDK Family and Other High Potential Kinase Targets* Reaction Biology 2021; Data on file. *Note that kinase activity is based on IC 50 values, a quantitative measure indicating the concentration needed to inhibit the listed kinase by 50% Naraza
Slide 29: CSF1 Antibody Reverses Chemoresistance in MCF-7 Xenografts
Colony - Stimulating Factor - 1 Antibody Reverses Chemoresistance in Human MCF - 7 Breast Cancer Xenografts Cancer Res. 2006;66(8):4349 - 4356. doi:10.1158/0008 - 5472.CAN - 05 - 3523 29
Slide 30: 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 31: Narazaciclib Inhibits Growth of Palbociclib Resistant 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 32: Rigosertib - Oncology
igoserti ONCOLOGY
Slide 33: Rigosertib identified as lead PLK1 inhibitor in RDEB cSCC
Clin Cancer Res March 7 2019 DOI:10.1158/1078 - 0432.CCR - 18 - 2661. PMID: 30846478 Rigosertib identified as lead PLK1 inhibitor in RDEB cSCC Primary Breast Keratinocytes Primary Foreskin Keratinocytes Primary RDEB 85 Keratinocytes Primary RDEB 93 Keratinocytes RDEB 2 SCC Keratinocytes RDEB 3 SCC K
Slide 34: Rigosertib's Single-agent Activity in RDEB-associated SCC
Rigosertib’s Promising Single - agent Activity in RDEB - associated SCC Complete remission of all cancerous skin lesions in 2 of 2 evaluable participants RDEB: Recessive dystrophic epidermolysis bullosa; SCC: Squamous cell carcinoma; Source: Laimer et al. Austrian Society of Dermatology and Venerolo
Slide 35: Summary - Pipeline
Summary - Pipeline
Slide 36: Pipeline Overview
Target Indication Preclinical Phase 1/2 Phase 2/3 Narazaciclib (DAILY) Solid tumors Narazaciclib + Letrozole (BOTH DAILY) 2L / 3L Low grade endometrioid endometrial cancer Rigosertib Epidermolysis bullosa - associated squamous cell carcinoma (rare disease) Virology Programs Target Indication Preclin
Slide 37: Thank You!
Thank You !