Traws Pharma, Inc. · NASDAQ:TRAW
Traws Pharma — Q2 2025 Earnings Presentation
47 slides from Traws Pharma's earnings presentation, Aug 14, 2025
Slide 1: Corporate Presentation
Corporate Presentation NASDAQ: TRAW August 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 best-in-class COVID program to replace existing therapies (>$6B revenue, 2024), prevent clinical rebound and explore treatment of Long COVI
Slide 4: Antiviral Drugs Represent a Significant Growth Sector for Biopharma
Antiviral Drugs Represent a Significant Growth Sector for Biopharma1 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
Slide 5: Pipeline Focused on Critical Threats from Respiratory Viral Diseases
Pipeline Focused on Critical Threats from Respiratory Viral Diseases Program/Market Preclinical Phase 1 Phase 2 Phase 3 Comments/Potential Next Steps • Demonstrated protection against mortality and disease in 3 species • Positive Phase 1 safety and PK data Bird Flu/Seasonal flu • HREC Phase 2 protoc
Slide 6: Key Program Highlights
Key Program Highlights COVID - Ratutrelvir H5N1 Bird Flu – Tivoxavir marboxil Potent across many SARS-CoV2 viral strains, with Broad potency against many viral strains, including superior in vitro suppression of COVID versus strains resistant to Tamiflu® and Xofluza® benchmarks and emerging drug can
Slide 7: Finance Dashboard
Finance Dashboard Program Milestone Market Potential1 • Application submitted for Phase 2 studies COVID: Potential best-in-class agent to replace to begin in Q3 2025 existing therapies, and prevent clinical rebound, as well as Long COVID. Expecting increased Ratutrelvir • Increase focus on preventin
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, MA D Phil Board of Directors Interim CEO, Director Jack E. Stover Chairman Charles Parker Interim Chief Financial Officer Iain D. Dukes, MA D Phil Interim CEO, Director Nikolay Savchuk, PhD Nikolay Savchuk, PhD COO, Directo
Slide 9: COVID-19
COVID-19 Ratutrelvir (TRX01) Investigational Main protease (Mpro) inhibitor Ritonavir-independent,10-day, once-daily dosing regimen 9
Slide 10: 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) 10 Notes: PAXLOVID® is a registered trademark of Pfizer, Inc. COVID estimates: https://www.cdc.gov/covid/php/surveillance/burden-estimates.html. Long COVID:
Slide 11: Long COVID Associates with Slow Viral Clearance and Viral Rebound
Long COVID Associates with Slow Viral Clearance and Viral Rebound During Acute SARS-CoV-2 Infection Symptoms associated with the risk of Long COVID 11 Herbert, C., et al., Poster 0935, 2025 Conference on Retroviruses and Opportunistic Infection (CROI)
Slide 12: Why Improving COVID Therapy Matters
Why Improving COVID Therapy Matters Significant cause of human disease and mortality in vulnerable populations 1 Declining vaccine use, regulatory hurdles slowing vaccine approval, and poor match of vaccine with current variants increases virus spread and potential for serious disease Increasing cli
Slide 13: 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 14: Ratutrelvir is Consistently More Potent than Competitor Agents
Ratutrelvir is Consistently More Potent than Competitor Agents for Suppressing COVID virus growth 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 COVID strains (result
Slide 15: Ratutrelvir is Active Against Viruses with Acquired Resistance
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 16: Phase 1 MAD Results: Daily Oral 600 mg Dose Sustains Drug Levels
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 17: 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 18: Phase 2a COVID19 Study Design
Phase 2a COVID19 Study Design Randomized, double-blind, controlled, international non-inferiority study to assess Study safety, tolerability, pharmacokinetics and activity of Ratutrelvir, oral, once-daily 600 Design mg for 10 days in patients eligible or ineligible for Paxlovid therapy compared to P
Slide 19: Phase 2a COVID19 Study Design
Phase 2a COVID19 Study Design Outcome Measures Include • Symptom relief • Hospitalization • Death • PK • Virus burden • Frequency of clinical rebound • Timing of clinical rebound 19
Slide 20: 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 Phase 2 target dose Next steps: Applied for Phase 2a non-inferiority trial evaluating ratutrelvir in patients eligible or ineli
Slide 21: Bird Flu
Bird Flu Tivoxavir marboxil (TXM, TRX100) A single-dose investigational, CAP-dependent endonuclease inhibitor for treatment or prevention of H5N1 bird flu 21
Slide 22: 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 There are no approved bird flu therapies Inadequate po
Slide 23: 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 candidate Broadly effective against bird flu strains including “Texas dairy worker strain”, demonstrated through in vivo studies A single dose reduced disease and prevented d
Slide 24: 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 viruses 2 Strain Designation Tivoxavir (TRX101) H5N1 viruses EC50 (nM) A/chicken/Idaho/22-011347-
Slide 25: Human H5N1 Virus is Resistant to Available Antiviral Drugs
Human 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 Baloxavir are
Slide 26: 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 27: 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 (TCID 50) 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 BL
Slide 28: Virus Challenge Study in Ferrets: Key Data to Support Clinical and Regulatory Strategy
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 29: 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 29 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sacrificed at thr
Slide 30: TXM Doses Prevented Rapid Body Weight Loss in Ferrets
TXM Doses Prevented Rapid Body Weight Loss in Ferrets Infected with Bird Flu Vehicle Control Equivalent to 240 mg human High dose (equivalent to 240 dose mg human dose Equivalent to 120 mg human Low dose (equivalent dose to 120 mg human dose) 30 Note: TRAW data on file. intranasal challenge/inoculat
Slide 31: 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 31 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 32: Single Oral Dose of TXM Increased Survival and Reduced Lung Virus Burden
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 32 Note: TRAW data on file. intranasal challenge/inocu
Slide 33: 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 34: Virus Challenge Study in Non-Human Primate: Key Data
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 35: Post-Exposure TXM Treatment Prevented Body Weight Loss in Infected Non-Human Primates
Post-Exposure TXM Treatment Prevented Body Weight Loss in A/H5N1- Infected Non-Human Primates (p < 0.004) 35 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group
Slide 36: Post-Exposure TXM Treatment Reduced A/H5N1 Titer in BAL and Nasal Swab
Post-Exposure TXM Treatment Reduced A/H5N1 Titer in Bronchoalveolar Lavage (BAL) and Nasal Swab (NS) Specimens from Infected Nonhuman Primates 36 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group
Slide 37: Post-Exposure TXM Treatment Reduced A/H5N1 Levels Detected by qPCR
Post-Exposure TXM Treatment Reduced A/H5N1 Levels Detected by Quantitative PCR (qPCR) in Bronchoalveolar Lavage (BAL) and Nasal Swab (NS) Specimens from Infected Nonhuman Primates 37 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group
Slide 38: 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 39: Tivoxavir Marboxil Treatment Reduced Lung Pathology in Nonhuman Primates
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 40: Phase 1 Study Design for TXM
Phase 1 Study Design for TXM Eligibility: Treatment Endpoints: Healthy volunteers Primary: Single-dose 80 mg,120 mg, 240 mg,regimen 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 41: 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 42: Pre-IND Meeting Feedback Received from FDA
Pre-IND Meeting Feedback Received from FDA ▪ Animal Rule intended to provide a path to approval in situations when human clinical studies would be unethical or impractical ▪ Allows FDA to rely on adequate and well- controlled animal efficacy studies to support approval of a drug Regulatory strategy
Slide 43: TXM Could Be a Fit for the Animal Rule
TXM Could Be a Fit for the “Animal Rule”1,2 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 3 Potential • Virus can be 100% fatal in
Slide 44: Phase 2a Seasonal/Pandemic Flu Study Design
Phase 2a Seasonal/Pandemic Flu Study Design Randomized, double-blind, controlled, international non-inferiority study to assess Study safety, tolerability, pharmacokinetics and activity of a one-time dose of TXM in Design subjects with acute, uncomplicated, community-acquired influenza compared to s
Slide 45: Phase 2a Seasonal Flu Study Design: Including H5N1 or H5N2 infections
Phase 2a Seasonal Flu Study Design: Including H5N1 or H5N2 infections 45
Slide 46: 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 best-in-class COVID program to replace existing therapies (>$6B revenue, 2024), prevent clinical rebound and mitigate the threat of Long CO
Slide 47: Thank You!
Thank You! www.trawspharma.com