Traws Pharma, Inc. · NASDAQ:TRAW
Traws Pharma — Investor Presentation (May 2025)
45 slides from Traws Pharma's investor presentation, May 2025
Slide 1: Corporate Presentation
Corporate Presentation NASDAQ: TRAW May, 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 statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities
Slide 3: Targeting Critical Viral Threats to Human Health
Targeting Critical Viral Threats to Human Health Focusing on small molecule antiviral drugs active against respiratory viruses with pandemic potential Potential first-in-class bird flu program, with an initial goal to build out the US strategic stockpile (estimated 300 million to 600 million doses1)
Slide 4: Antiviral Drugs Represent a Significant Growth Sector for Biopharma
Antiviral Drugs Represent a Significant Growth Sector for Biopharma Antiviral drugs are small molecules that inhibit the activity of critical viral enzymes and are used specifically to treat active infections or to prevent virus spread to close contacts of an infected person Antiviral drugs attack a
Slide 5: High-Potential Antiviral Pipeline Focused on Critical Threats to Human Health from Respiratory Viral Diseases
High-Potential Antiviral Pipeline Focused on Critical Threats to Human Health from Respiratory Viral Diseases Program/Market Preclinical Phase 1 Phase 2 Phase 3 Comments/Potential Next Steps Respiratory Viruses • Demonstrated protection against Bird Flu/Seasonal flu mortality and disease in 3 specie
Slide 6: Key Program Highlights
Key Program Highlights Influenza– Tivoxavir marboxil (TXM) COVID - Ratutrelvir Broad potency against many viral strains, including Potent across many SARS-CoV2 viral strains, with strains resistant to Tamiflu® and Xofluza® superior in vitro suppression of COVID versus benchmarks and emerging drug ca
Slide 7: Finance Dashboard
Finance Dashboard Anticipated Upcoming Milestones Market Potential1 Bird Flu: In short term, strategic stockpile Program Milestone approx. 300,000,000 - 600,000,000 doses. Update on FDA discussions regarding the Seasonal Flu: Potential best in class agent to Bird flu replace existing therapies addre
Slide 8: Strong Team with Track Record of Executing and Creating Value
Strong Team with Track Record of Executing and Creating Value Iain D. Dukes, D Phil Board of Directors Interim CEO, Director Jack E. Stover Chairman Nora Brennan Interim Chief Financial Officer Iain D. Dukes, D Phil Interim CEO, Director Nikolay Savchuk, PhD Nikolay Savchuk, PhD COO, Director Chief
Slide 9: Bird Flu
Bird Flu Tivoxavir marboxil (TXM, TRX100) A single-dose investigational, CAP-dependent endonuclease inhibitor for treatment or prevention of H5N1 bird flu 9
Slide 10: Influenza is a Critical Threat To Human Health Today
Influenza is a Critical Threat To Human Health Today High pandemic potential with no currently approved treatments High historical human mortality from bird flu, with human pandemic potential1 Major and increasing agricultural impact of bird flu No bird flu therapies approved today Inadequate potenc
Slide 11: Tivoxavir Marboxil (TRX100/TXM): Value Proposition for Bird Flu
Tivoxavir Marboxil (TRX100/TXM): Value Proposition for Bird Flu Differentiating features of TXM, a potent oral antiviral drug Broadly effective against bird flu strains including “Texas dairy worker strain”, demonstrated through in vivo studies A single dose reduced disease and prevented death in 3
Slide 12: Tivoxavir Potently Inhibits Highly Pathogenic Avian Influenza Viruses
Tivoxavir Potently Inhibits Highly Pathogenic Avian Influenza Viruses Tivoxavir (the active metabolite of TRX100) inhibits replication of HPAI H5N1 avian influenza viruses and reference (H3N2) influenza viruses2 Strain Designation Tivoxavir (TRX101) H5N1 viruses EC50 (nM) A/chicken/Idaho/22-011347-0
Slide 13: Circulating H5N1 Virus is Resistant to Available Antiviral Drugs
Circulating H5N1 Virus is Resistant to Available Antiviral Drugs Multiple mutations related to increased transmission and growth in mammalian cells and natural resistance to oseltamivir (Tamiflu®) and baloxavir (Xofluza® ) Nine Mutations in A/Texas/37/2024 were Not Present in Oseltamivir and Baloxav
Slide 14: TXM Provides 100% Protection Against Lethal Bird Flu Challenge in Mice
TXM Provides 100% Protection Against Lethal Bird Flu Challenge in Mice Female BALB/c Mice Mouse antiviral study using Survival Curve bird flu (H5N1) transmitted 100 80 Vehicle Control TRX-100 from cattle to a dairy worker % Survival 60 40 Bird Flu 20 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Days Post Ch
Slide 15: TXM Achieved Complete Viral Clearance in the Lung
TXM Achieved Complete Viral Clearance in the Lung Based on murine viral challenge studies1 Day 3 Lung Virus Titers (TCID50) Animal Group Virus Titer Animal Group Virus Titer 31 7x108 46 BLLQ 32 1.3x107 47 BLLQ TXM 33 Vehicle 1.3x108 48 Day 1 dose of 50 BLLQ mg/kg 34 8.2x108 49 BLLQ 35 1.2x107 50 BLL
Slide 16: Virus Challenge Study in Ferrets: Key Data to Support Clinical and Regulatory Strategy for TXM in Bird Flu
Virus Challenge Study in Ferrets: Key Data to Support Clinical and Regulatory Strategy for TXM in Bird Flu Promising topline data in ferret model using virus isolated from a dairy worker. Viral inoculum: 1X103 TCID50 of A/Texas/37/2024 H5N1 via intranasal instillation Oral treatment: 8 hours after v
Slide 17: TXM Dose-dependently Increased Survival in Ferrets Infected with Bird Flu
TXM Dose-dependently Increased Survival in Ferrets Infected with Bird Flu Vehicle Control Equivalent to 240 mg human dose Equivalent to 120 mg human dose 17 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sacrificed at thr
Slide 18: TXM Doses Prevented Rapid Body Weight Loss in Ferrets Infected with Bird Flu
TXM Doses Prevented Rapid Body Weight Loss in Ferrets Infected with Bird Flu Vehicle Control Equivalent to 240 mg human High dose (equivalent dose to 240 mg human dose Equivalent to 120 mg human Low dose (equivalent dose to 120 mg human dose) 18 Note: TRAW data on file. intranasal challenge/inoculat
Slide 19: Single Oral Dose of TXM Reduced Lung Virus Burden in Ferrets
Single Oral Dose of TXM Reduced Lung Virus Burden in Ferrets Vehicle Control Equivalent to 240 mg human dose Equivalent to 120 mg human dose 19 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sacrificed at three days after
Slide 20: Single Oral Dose of TXM Increased Survival and Reduced Lung Virus Burden in Bird Flu-Infected Ferrets
Single Oral Dose of TXM Increased Survival and Reduced Lung Virus Burden in Bird Flu-Infected Ferrets Control – no drug Equivalent to 120 mg Equivalent to 240 mg Viral RNA 0% survival human dose human dose copies per 30% survival 50% survival mL 20 Note: TRAW data on file. intranasal challenge/inocu
Slide 21: TXM Treatment Reduced Lung Pathology in Ferrets Infected with Bird Flu Virus
TXM Treatment Reduced Lung Pathology in Ferrets Infected with Bird Flu Virus: Dose-Dependent Impact on Cellular Infiltration of the Lungs Day 3: Control Day 31: Human Equivalent 120 mg Day 32: Human Equivalent 240 mg Cellular infiltration/inflammation: basophilic, dark-staining areas (solid arrows)
Slide 22: Virus Challenge Study in Non-Human Primate: Key Data to Support Clinical and Regulatory Strategy for TXM in Bird Flu
Virus Challenge Study in Non-Human Primate: Key Data to Support Clinical and Regulatory Strategy for TXM in Bird Flu Promising topline data in non-human primate (NHP) model using virus isolated from a dairy worker. Viral inoculum:1X106 TCID50 of A/Texas/37/2024 H5N1 with half delivered via intranasa
Slide 23: TXM Dose Prevented Body Weight Loss in Bird Flu-Infected Non-Human Primates
Percent body weight changes by Study Day 10 in treated versus control Untreated control Treated TXM Dose Prevented Body Weight Loss in Bird Flu-Infected Non- Human Primates (** p < 0.004) 23 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group
Slide 24: Single Oral Dose of TXM Blocks Bird Flu Replication in the Lungs of NHPs
Single Oral Dose of TXM Blocks Bird Flu Replication in the Lungs of NHPs Control Animals – no drug treatment Virus Infectivity per mL Animals treated with equivalent of human dose 480 mg • Results for individual animals are depicted • Results from bronchoalveolar lavage samples collected on Study Da
Slide 25: Tivoxavir Marboxil Treatment Reduced Lung Pathology in Nonhuman Primates Infected with Bird Flu Virus
Tivoxavir Marboxil Treatment Reduced Lung Pathology in Nonhuman Primates Infected with Bird Flu Virus Cellular infiltration and inflammation: basophilic, dark-staining areas (solid arrows) Untreated TXM-treated1 1.25x Control (untreated): extensive areas of basophilic staining indicating cellular in
Slide 26: Phase 1 Study Design for TXM
Phase 1 Study Design for TXM Eligibility: Treatment Endpoints: Healthy volunteers Primary: Single-dose 80 mg,120 regimen mg, 240 mg, 480 mg doses Flu-negative men and • 8 patients/dose (6 active, 2 placebo) • Safety and tolerability women, ages 18-64 per cohort years of age • All cohorts were fasted
Slide 27: Phase 1 Data Show that TXM Maintains Plasma Blood Levels > EC90 for ~3 weeks
Phase 1 Data Show that TXM Maintains Plasma Blood Levels > EC90 for ~3 weeks (NCT06757738) No treatment related adverse events Plasma drug levels above EC90 for ~3 weeks days after single 480 mg dose in healthy volunteers Tivoxavir in plasma (ng/mL) EC90 ~0.82 ng/mL 3 weeks Time (hours) Notes: Four
Slide 28: Pre-IND Meeting Request Submitted March 21, 2025
Pre-IND Meeting Request Submitted March 21, 2025 Meeting granted; briefing package provided to FDA on April 24, 2025 ▪ Animal Rule intended to provide a path to approval in situations when human challenge studies would not be ethical and field trials are not possible ▪ Allows FDA to rely on adequate
Slide 29: TXM Could Be a Fit for the "Animal Rule"
TXM Could Be a Fit for the “Animal Rule” Human challenge studies of bird flu are not possible • Virus evolved to a more virulent strain (dairy worker, mild symptoms) Exceptional Pathogenic • History of A/H5N1 virus strains with up to 50% case fatality rate Potential • Virus can be 100% fatal in 3-5
Slide 30: Seasonal Influenza
Seasonal Influenza Tivoxavir marboxil (TXM, TRX100) Potency against seasonal influenza, including drug resistant strains 30
Slide 31: Influenza is a Critical Threat To Human Health Today
Influenza is a Critical Threat To Human Health Today1 Influenza continues to be a major cause of mortality and burden on the healthcare system Seasonal variation necessitates continual development of vaccines and vaccines provide incomplete protection and have limited utilization Antiviral drugs att
Slide 32: Influenza Continues to be a Critical Threat to Human Health
Influenza Continues to be a Critical Threat to Human Health 32 Notes: CDC information
Slide 33: Phase 2a Seasonal Flu Study Design
Phase 2a Seasonal Flu Study Design Randomized, double-blind, controlled, international non-inferiority study to assess Study safety, tolerability, pharmacokinetics and activity of a single dose of TXM in subjects Design with acute, uncomplicated, community-acquired influenza Expected to enroll ~30 i
Slide 34: COVID-19
COVID-19 Ratutrelvir (TRX01) Investigational Main protease (Mpro) inhibitor Ritonavir-independent,10-day, single pill, once-daily dosing regimen 34
Slide 35: COVID Continues to be a Critical Threat to Human Health
COVID Continues to be a Critical Threat to Human Health Risk of viral rebound (>20% of PAXLOVID treated cases) and Long COVID (10-20% of cases) 35 Notes: PAXLOVID® is a registered trade mark of Pfizer, Inc. COVID estimates: https://www.cdc.gov/covid/php/surveillance/burden-estimates.html. Long COVID
Slide 36: Long COVID Associates with Slow Viral Clearance and Viral Rebound During Acute SARS-CoV-2 Infection
Long COVID Associates with Slow Viral Clearance and Viral Rebound During Acute SARS-CoV-2 Infection Symptoms associated with the risk of Long COVID 36 Herbert, C., et al., Poster 0935, 2025 Conference on Retroviruses and Opportunistic Infection (CROI)
Slide 37: Why Improving COVID Therapy Matters
Why Improving COVID Therapy Matters Significant cause of human disease and mortality in vulnerable populations The drop in vaccine use, regulatory hurdles slowing vaccine approval, and poor match of vaccine with current variants increases the spread and potential for disease Increasing clinical and
Slide 38: Ratutrelvir Value Proposition for COVID/Long COVID
Ratutrelvir Value Proposition for COVID/Long COVID Favorable profile could enable accessibility to a larger number of vulnerable individuals Differentiating features of ratutrelvir, a potent oral antiviral agent Broadly more active against original COVID strains, variants of concern, and emerging dr
Slide 39: Ratutrelvir is Consistently More Potent than Competitor Agents in Suppression of COVID in vitro
Ratutrelvir is Consistently More Potent than Competitor Agents in Suppression of COVID in vitro Superior to nirmatrelvir or ibuzatrelvir, across multiple virus strains EC50 values for Mpro inhibitors against multiple Representative EC50 values for Mpro inhibitors and the COVID strains (results in nM
Slide 40: Ratutrelvir is Active Against Viruses with Acquired Resistance to PAXLOVID or Ensitrelvir
Ratutrelvir is Active Against Viruses with Acquired Resistance to PAXLOVID® or Ensitrelvir Overall Rate of Resistant Mutations Decreasing Effect of reported mutations Clinical Treatment Variants Drug Activity by > 2.5 fold on Ratutrelvir Activity3 G138S Not Detected E166V <2.5 fold H172Y Not Detecte
Slide 41: Phase 1 MAD Results: Daily Oral 600 mg Dose Sustains Drug Levels above EC90
Phase 1 MAD Results: Daily Oral 600 mg Dose Sustains Drug Levels above EC90 for 10 days in Healthy Volunteers (NCT06402136) No treatment related adverse events Plasma drug levels are similar during 0-24 h on first (Day 0) Daily plasma drug levels (24 h after dosing) remain and last (Day 9) of 600 mg
Slide 42: Consistent High Plasma Drug Levels Could Allow for Protection Against New Variants
Consistent High Plasma Drug Levels Could Allow for Protection Against New Variants No treatment related adverse events Plasma drug levels (24 h Ctrough values for Days 1-9) Above EC90 for virus suppression and within the target PK window (>25 nM and below the exposure limit): based on more intensive
Slide 43: Ratutrelvir has Successfully Completed Phase 1 Studies
Ratutrelvir has Successfully Completed Phase 1 Studies Phase 1 safety and dose escalation studies: have demonstrated excellent overall safety and tolerability and defined a target dose Next steps: Submit a briefing document to regulatory authorities in Q2 2025 for acute treatment, rebound prevention
Slide 44: Targeting Critical Viral Threats to Human Health
Targeting Critical Viral Threats to Human Health Focusing on small molecule antiviral drugs active against respiratory viruses with pandemic potential Potential first-in-class bird flu program, with an initial goal to build out the US strategic stockpile (estimated 300 million to 600 million doses1)
Slide 45: Thank You!
Thank You! www.trawspharma.com