Traws Pharma, Inc. · NASDAQ:TRAW
Traws Pharma — Investor Presentation (August 2025)
47 slides from Traws Pharma's investor presentation, Aug 14, 2025
Slide 1: August 2025 Corporate Presentation
NASDAQ: TRAW August 2025 Corporate Presentation
Slide 2: Forward-looking statements
Forward - looking statements 2 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 Secu
Slide 3: Targeting Critical Viral Threats to Human Health
Targeting Critical Viral Threats to Human Health 3 Potential first - in - class bird flu program , with an initial goal to build out the US strategic stockpile (estimated 300 million to 600 million doses 2 ) Potential best - in - class COVID program to replace existing therapies (>$6B revenue, 2024)
Slide 4: Antiviral Drugs Represent a Significant Growth Sector for Biopharma
4 Antiviral drugs attack a conserved virus component that does not vary according to seasonal changes in virus 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
Slide 5: Pipeline programs and next steps
Comments/Potential Next Steps Phase 3 Phase 2 Phase 1 Preclinical Program/Market • Demonstrated protection against mortality and disease in 3 species • Positive Phase 1 safety and PK data • HREC Phase 2 protocol approved to study TXM in bird flu and seasonal flu. • Type D FDA meeting feedback clarif
Slide 6: Key Program Highlights
Key Program Highlights 6 Source: TRAW data on file. Notes: PK = pharmacokinetics. PAXLOVID® is a registered trademark of Pfizer, Inc. Tamiflu® is a tr ade mark registered of Roche. Xofluza ® is a registered trademark of Genentech Pharmaceuticals COVID - Ratutrelvir Broad potency against many viral s
Slide 7: Selected Financial Information and Milestones
COVID: Potential b est - in - class agent to replace existing therapies, and prevent clinical rebound, as well as Long COVID. Expecting increased demand for COVID therapy as vaccine effectiveness/use declines Bird Flu: In short to medium term, US strategic stockpile approx. 300,000,000 - 600,000,000
Slide 8: Strong Team with Track Record of Executing and Creating Value
Strong Team with Track Record of Executing and Creating Value Robert R. Redfield, MD Chief Medical Officer C. David Pauza, PhD Chief Science Officer Charles Parker Interim Chief Financial Officer Board of Directors Nikolay Savchuk , PhD Chief Operating Officer, Director Chairman Jack E. Stover Inter
Slide 9: COVID - Ratutrelvir (TRX01)
9 COVID - 19 Ratutrelvir (TRX01) Investigational Main protease ( Mpro ) inhibitor Ritonavir - independent,10 - day, once - daily dosing regimen
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 C
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 11 Symptoms associated with the risk of Long COVID 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 12 Increasing clinical and economic burden of Long COVID Many people seeking COVID19 therapy are ineligible for PAXLOVID® due to drug interactions of the boosting agent ritonavir. Estimat
Slide 13: Ratutrelvir Value Proposition for COVID/Long COVID
Ratutrelvir Value Proposition for COVID/Long COVID 13 Differentiating features of ratutrelvir , a potent oral antiviral agent Dose at RP2D maintains favorable PK, with plasma drug levels at > 4 - times the EC 9 0, and we predict that drug concentrations will be higher in lung compared to blood plasm
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 14 Superior to nirmatrelvir or ibuzatrelvir , across multiple virus strains Notes: Data represents a comparison of literature data v. Traws ’ in vitro assay results. EC50 – effective concentrat
Slide 15: Ratutrelvir is Active Against Viruses with Acquired Resistance
Ratutrelvir is Active Against Viruses with Acquired Resistance to PAXLOVID® or Ensitrelvir 15 Notes/Sources: PAXLOVID® is a registered trademark of Pfizer, Inc. 1 Tamura, et al. "Emerging SARS - CoV - 2 Resistance After Antiviral Treatment." JAMA Network Open 7(9): e2435431 - e2435431. 2 Uehara, et
Slide 16: Phase 1 MAD Results: Drug Levels above EC90 for 10 days
Phase 1 MAD Results: Daily Oral 600 mg Dose Sustains Drug Levels above EC 90 for 10 days in Healthy Volunteers (NCT06402136) 16 No treatment related adverse events Source: TRAWS data on file, Notes: MAD = multiple ascending dosing 9,415 nM (Exposure Limit) 25 nM EC90 (3xEC50) Multiple Ascending Dose
Slide 17: Consistent High Plasma Drug Levels Could Allow Protection Against New Variants
Consistent High Plasma Drug Levels Could Allow for Protection Against New Variants 17 No treatment related adverse events Source: TRAWS data on file, Notes: MAD = multiple ascending dosing study 9,415 nM (Exposure Limit) 25 nM EC90 (3xEC50) Multiple Ascending Doses in human 0 1 2 3 4 5 6 7 8 9 10 11
Slide 18: Phase 2a COVID19 Study Design
Phase 2a COVID19 Study Design 18 Enroll 90 COVID19 - positive subjects 18 - 65 years of age Three groups (n=30 each): • Daily 600 mg of ratutrelvir for 10 days in Paxlovid eligible patients • Paxlovid for 5 days • Daily 600 mg of ratutrelvir for 10 days in patients ineligible for Paxlovid Evaluate t
Slide 19: Phase 2a COVID19 Study Design Outcome Measures
Phase 2a COVID19 Study Design 19 Outcome Measures Include • Symptom relief • Hospitalization • Death • PK • Virus burden • Frequency of clinical rebound • Timing of clinical rebound
Slide 20: Ratutrelvir has Successfully Completed Phase 1 Studies
20 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 o
Slide 21: Bird Flu Tivoxavir marboxil (TXM, TRX100)
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 22 Major and increasing agricultural impact of bird flu There are n o approved bird flu therapies 4 5 High historical human mortality from bird flu, with human pandemic potential 1 L im
Slide 23: Tivoxavir Marboxil: Value Proposition for Bird Flu
Tivoxavir Marboxil (TRX100/TXM): Value Proposition for Bird Flu 23 Differentiating features of TXM, a potent oral antiviral drug candidate A single dose reduced disease and prevented death in 3 preclinical animal models used commonly in flu drug development, with large reductions in lun g virus leve
Slide 24: Tivoxavir Potently Inhibits Highly Pathogenic Avian Influenza Viruses
Tivoxavir Potently Inhibits Highly Pathogenic Avian Influenza Viruses 24 Tivoxavir (the active metabolite of TRX100) inhibits replication of HPAI H5N1 avian influenza viruses and reference (H3N2) influenza viruses 2 Note: Based on avian influenza virus circulating in 2022 - 2023, 2. Results from the
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 ® ) 25 Nine Mutations in A/Texas/37/2024 were Not Present in the Bovine Isolate Oselt
Slide 26: TXM Provides 100% Protection Against Lethal Bird Flu Challenge in Mice
Mouse antiviral study using bird flu (H5N1) transmitted from cattle to a dairy worker 26 Notes: Challenge dose via intranasal delivery. TXM = tivoxavir marboxil , 5 animals per group sacrificed on D3 for determination of virus titer in lungs (data pending). Data on file, TRAWS Pharma. Virus Challeng
Slide 27: TXM Achieved Complete Viral Clearance in the Lung
27 1. Virus challenge protocol per slide 14. TCID = tissue culture infectious dose Virus Titer Group Animal 7x10 8 Vehicle 31 1.3x10 7 32 1.3x10 8 33 8.2x10 8 34 1.2x10 7 35 Virus Titer Group Animal BLLQ TXM Day 1 dose of 50 mg/kg 46 BLLQ 47 BLLQ 48 BLLQ 49 BLLQ 50 Virus titer – TCID 50 /gram of tis
Slide 28: Virus Challenge Study in Ferrets
Virus Challenge Study in Ferrets: Key Data to Support Clinical and Regulatory Strategy for TXM in Bird Flu 28 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at three days after viral inoculation for lung virus
Slide 29: TXM Dose-Dependently Increased Survival in Ferrets
Vehicle Control Equivalent to 240 mg human dose Equivalent to 120 mg human dose TXM Dose - dependently Increased Survival in Ferrets Infected with Bird Flu 29 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at
Slide 30: TXM Doses Prevented Rapid Body Weight Loss in Ferrets
Vehicle Control High dose (equivalent to 240 mg human dose Low dose (equivalent to 120 mg human dose) Vehicle Control Equivalent to 240 mg human dose Equivalent to 120 mg human dose TXM Doses Prevented Rapid Body Weight Loss in Ferrets Infected with Bird Flu 30 Note: TRAW data on file. intranasal ch
Slide 31: 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 Single Oral Dose of TXM Reduced Lung Virus Burden in Ferrets 31 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at three days afte
Slide 32: Single Oral Dose of TXM Increased Survival and Reduced Lung Virus Burden
Control – no drug 0% survival Equivalent to 240 mg human dose 50% survival Equivalent to 120 mg human dose 30% survival Viral RNA copies per mL Single Oral Dose of TXM Increased Survival and Reduced Lung Virus Burden in Bird Flu - Infected Ferrets 32 Note: TRAW data on file. intranasal challenge/ino
Slide 33: TXM Treatment Reduced Lung Pathology in Ferrets
TXM Treatment Reduced Lung Pathology in Ferrets Infected with Bird Flu Virus: Dose - Dependent Impact on Cellular Infiltration of the Lungs 33 Note: TRAW data on file. intranasal infection with A/Texas/37/2024 (H5N1); lung pathology assessed three days after infectio n. Note: 1 = TXM dose of 10.6 mg
Slide 34: Virus Challenge Study in Non-Human Primate
Virus Challenge Study in Non - Human Primate: Key Data to Support Clinical and Regulatory Strategy for TXM in Bird Flu 34 Oral treatment 12 hours after non - lethal virus inoculation Dose: One dose (480 mg human equivalent dose) Two Groups: 5 animals per group (treated and control) Endpoints: Virus
Slide 35: Post-Exposure TXM Treatment Prevented Body Weight Loss in 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 Reduced A/H5N1 Titer in BAL and Nasal Swabs
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 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 Lungs of NHPs
Control Animals – no drug treatment • Results for individual animals are depicted • Results from bronchoalveolar lavage samples collected on Study Day 3 and analyzed by TCID 50 assay • < 10e3 – below the lower limit of quantitation Animals treated with equivalent of human dose 480 mg Virus Infectivi
Slide 39: TXM Treatment Reduced Lung Pathology in Nonhuman Primates
Tivoxavir Marboxil Treatment Reduced Lung Pathology in Nonhuman Primates Infected with Bird Flu Virus 39 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group: Based on Day 10 necropsy. X = ma gni fication. 1 = TXM dose at 480 mg human equivalent t dose Cellular
Slide 40: Phase 1 Study Design for TXM
Phase 1 Study Design for TXM 40 Notes: TRAW data on file. Sentinels observed for 24 hours before dosing Main Group. Tivoxavir marboxil dose given as powder - in - capsule. Safety Review Committee evaluation 10 days after dosing. Pharmacokinetic study continued until 28 days after dosing. Eligibility
Slide 41: Phase 1 Data Show TXM Maintains Plasma Levels > EC90 for ~3 Weeks
Phase 1 Data Show that TXM Maintains Plasma Blood Levels > EC 90 for ~3 weeks (NCT06757738) 41 No treatment related adverse events Notes: Four doses evaluated (80, 120, 240, 480mg, all fasted). Each group included a sentinel dose with 24h observation (1 ac tiv e, 1 placebo), following by the main gr
Slide 42: Pre-IND Meeting Feedback Received from FDA
Pre - IND Meeting Feedback Received from FDA 42 Note: CFR314.600 thru 314.650 , October 2015 , https://www.fda.gov/media/88625/download Regulatory strategy focused on the Animal Rule to accelerate development and combined dose - ranging efficacy/safety study in seasonal and bird flu infected patient
Slide 43: TXM Could Be a Fit for the Animal Rule
Sources: 1. CFR314.600 thru 314.650 , October 2015 , https://www.fda.gov/media/88625/download. 2 . Traws information 3. b ird flu case fatality rate: WHO information : https://cdn.who.int/media/docs/default - source/wpro --- documents/emergency/surveillance/avian - influenza/ai_20250131.pdf . TXM Co
Slide 44: Phase 2a Seasonal/Pandemic Flu Study Design
Phase 2a Seasonal/Pandemic Flu Study Design 44 Expected to enroll ~150 influenza - positive subjects 18 - 65 years of age Expected to incorporate five dosing groups (n=30 each): • TXM dose level 1 (seasonal) • TXM dose level 2 (seasonal) • TXM dose level 2 (H5N1) • Baloxavir marboxil (seasonal) • Os
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 46 Potential first - in - class bird flu program , with an initial goal to build out the US strategic stockpile (estimated 300 million to 600 million doses 2 ) Potential best - in - class COVID program to replace existing therapies (>$6B revenue, 2024
Slide 47: Thank You!
Thank You! www.trawspharma.com