Traws Pharma, Inc. · NASDAQ:TRAW
Traws Pharma — Investor Day (March 2025)
45 slides from Traws Pharma's investor day presentation, Mar 31, 2025
Slide 1: Investor Event March 31, 2025
Investor Event March 31, 2025 Targeting Critical Threats to Human Health
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: Introduction
Introduction 3 Werner Cautreels, PhD Chief Executive Officer
Slide 4: Agenda
Agenda Advancing novel treatment for critical threats to human health: bird flu and COVID 4 Welcome Bird Flu COVID Discussion and Q&A Closing Statements Werner Cautreels, PhD, CEO, and Iain D. Dukes, D Phil, Executive Chairman Pandemic risk and the opportunity for tivoxavir marboxil (TXM): Robert R.
Slide 5: A team with a strong track record of executing and creating value
A team with a strong track record of executing and creating value Robert R. Redfield, MD Chief Medical Officer C. David Pauza, PhD Chief Scientific Officer Werner Cautreels, PhD Chief Executive Officer Nora Brennan Interim Chief Financial Officer Board of Directors Demonstrated expertise in anti - v
Slide 6: High-potential antiviral pipeline focused on critical threats to human health
Comments/Potential Next Steps Phase 3 Phase 2 Phase 1 Preclinical Program/Market Respiratory Viruses • Demonstrated protection against mortality and disease in 3 species • Positive Phase 1 safety and PK data • Ongoing interactions with FDA Bird Flu Tivoxavir marboxil • Demonstrated suppression of a
Slide 7: Bird Flu
Bird Flu H5N1 b ird flu and the increasing risk for wider spread in the human population 7 Robert Redfield, MD, CMO
Slide 8: Why is bird flu a critical threat to human health today?
Why is bird flu a critical threat to human health today? High pandemic potential with no currently approved treatments 8 Major expanding agricultural impact Limited countermeasures available for both animal and human disease 4 5 High human mortality S ignificant limitation of current flu vaccines Se
Slide 9: Pandemic risk: broad spread among animals increases risk of human transmission
9 Millions of infected animals Thousand of infected workers One event starts a pandemic Why is bird flu a critical threat to human health today? Pandemic risk: broad spread among animals increases the risk of human transmission, mutation Sources: TRAWS internal
Slide 10: The tivoxavir marboxil (TXM) value proposition for bird flu
The tivoxavir marboxil (TXM) value proposition for bird flu 10 Differentiating features of TXM, a potent oral anti - viral agent One dose provided protection from disease and mortality in 3 well - accepted preclinical models One dose maintained plasma levels above the EC 90 for approximately 3 weeks
Slide 11: Bird Flu/Influenza Tivoxavir marboxil (TRX100)
Bird Flu/Influenza Tivoxavir marboxil (TRX100) A single - dose investigational, CAP - dependent endonuclease inhibitor for treatment or prevention of H5N1 bird flu 11 C. David Pauza, PhD, CSO
Slide 12: Potent preclinical inhibition of highly pathogenic avian influenza viruses
Potent preclinical inhibition of highly pathogenic avian influenza viruses 12 TRX101 (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 t
Slide 13: Mutation profile of H5N1 virus from a Texas dairy worker
Mutation profile of H5N1 Virus from a Texas dairy worker Multiple mutations related to increased transmission and growth in mammalian cells and natural resistance to oseltamivir and baloxavir 13 Nine Mutations in A/Texas/37/2024 were Not Present in the Bovine Isolate Oseltamivir and Baloxavir are Le
Slide 14: Mouse antiviral study using bird flu H5N1
Mouse antiviral study using bird flu (H5N1) transmitted from cattle to a dairy worker 14 Notes: Challenge dose via intranasal delivery. TRX - 100 = tivoxavir marboxil, TVX. 5 animals per group sacrificed on D3 for deter mination of virus titer in lungs (data pending). Data on file, TRAWS Pharma. Vir
Slide 15: Tivoxavir achieved complete viral clearance in the lung
15 1. Virus challenge protocol per slide 13. 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 16: Virus challenge study in ferrets
Virus challenge study in ferrets could provide key data to support clinical and regulatory strategy for tivoxavir marboxil in bird flu 16 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 vira
Slide 17: TXM doses increased survival in ferrets infected with bird flu
Vehicle Control Equivalent to 240 mg human dose Equivalent to 120 mg human dose TXM doses increased survival in ferrets infected with bird flu 17 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 af
Slide 18: 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 18 Note: TRAW data on file. intranasal ch
Slide 19: 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 19 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 aft
Slide 20: Single oral dose of TXM increases survival in infected ferrets
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 increases survival and reduces lung virus burden in bird flu - infected ferrets 20 Note: TRAW data on file. intranasal challenge/in
Slide 21: Virus challenge study in non-human primate
Virus challenge study in non - human primate could provide key data to support clinical and regulatory strategy for tivoxavir marboxil in bird flu 21 Oral treatment 12 hours after non - lethal virus inoculation Dose: One dose (480 mg human equivalent dose) Two Groups: 5 animals per group (treated an
Slide 22: TXM dose prevented body weight loss in infected non-human primates
Percent body weight changes by Study Day 10 in treated versus control TXM dose prevented body weight loss in bird flu - infected non - human primates (** p < 0.004) 22 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group
Slide 23: Single oral dose of TXM blocks bird flu replication in NHP lungs
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 24: Phase 1 study designed to inform dose selection of tivoxavir marboxil
Phase 1 study designed to inform dose selection of tivoxavir marboxil 24 Notes: TRAW data on file. Sentinels observed for 24 hours before dosing Main Group. Tivoxavir marboxil dose given as powder - in - c apsule. Safety Review Committee evaluation 10 days after dosing. Pharmacokinetic study continu
Slide 25: Positive Phase 1 data: plasma levels above EC90 for ~3 weeks
Positive Phase 1 data show that tivoxavir marboxil maintains plasma blood levels > EC 90 for ~3 weeks (NCT06757738) 25 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),
Slide 26: Pre-IND meeting request submitted; Animal Rule regulatory strategy
Pre - IND meeting request submitted March 21, 2025 26 Regulatory strategy is focused on accelerating development by accessing the “Animal Rule” Note: CFR314.600 thru 314.650 , October 2015 , https://www.fda.gov/media/88625/download Product Development Under the Animal Rule ▪ Intended to provide a pa
Slide 27: TXM could be a fit for the Animal Rule
Note: CFR314.600 thru 314.650, October 2015, https://www.fda.gov/media/88625/download. bird flu case fatality rate: WHO information : https://cdn.who.int/media/docs/default - source/wpro --- documents/emergency/surveillance/avian - influenza/ai_20250131.pdf TXM could be a fit for the “Animal Rule” H
Slide 28: COVID continues to spread, mutate and kill
28 COVID - 19 …continues to spread … continues to mutate … continues to kill Robert Redfield, MD, CMO
Slide 29: Why improving COVID therapy matters
Why improving COVID therapy matters Significant cause of human disease and mortality in vulnerable population 29 Increasing clinical and economic burden of Long COVID Significant limitations for current approved antiviral, PAXLOVID®, in vulnerable populations including the elderly, immunocompromised
Slide 30: Why is COVID a critical threat: viral rebound and long COVID
Why is COVID a critical threat to human health today? Risk of viral rebound (>20% of PAXLOVID treated cases) and long COVID (10 - 20% of cases) 30 Notes: PAXLOVID® is a registered trade mark of Pfizer, Inc. COVID estimates: https://www.cdc.gov/covid/php/surveillance/burde n - e stimates.html. Long C
Slide 31: The ratutrelvir value proposition for COVID/Long COVID
The ratutrelvir value proposition for COVID/Long COVID 31 Differentiating features of ratutrelvir, a potent oral anti - viral agent Dose at RP2D maintains favorable PK, with plasma drug levels at ~13X the EC 50, with high lung accumulation compared to the blood Broad resistance profile against nativ
Slide 32: COVID - Ratutrelvir (TRX01)
32 COVID - 19 Ratutrelvir (TRX01) Investigational Main protease (Mpro) inhibitor Ritonavr - independent,10 - day, single - daily dosing regimen C. David Pauza, PhD, CSO
Slide 33: Ratutrelvir is consistently more potent for suppression of COVID in vitro
Ratutrelvir is consistently more potent for suppression of COVID in vitro 33 Greater inhibition than benchmark, nirmatrelvir, the active ingredient in PAXLOVID® (preclinical studies), or Pfizer’s next generation Mpro inhibitor, Ibuzatrelvir, across multiple strains of COVID viruses Notes: Data repre
Slide 34: Emerging resistance to nirmatrelvir and ensitrelvir will not impact ratutrelvir
Emerging resistance to nirmatrelvir and ensitrelvir will not impact ratutrelvir usage 34 Ratutrelvir has a differentiated profile of drug resistance mutations, compared to resistance emerging in clinical trials of nirmatrelvir or ensitrelvir Frequency of Nirmatrelvir - Resistance Mutations 1 M49L Se
Slide 35: Phase 1 MAD results: daily dose sustains drug levels above EC90
Phase 1 MAD Results: Daily oral 600 mg dose sustains drug levels above EC 90 for 10 days in healthy volunteers (NCT06402136) 35 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 36: Consistent high plasma drug levels could allow protection against new variants
Consistent high plasma drug levels could allow for protection against new variants 36 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) 110 nM (13xEC50) Plasma drug l evels (24 h C trough values
Slide 37: Long COVID associates with slow viral clearance and viral rebound
Long COVID associates with slow viral clearance and viral rebound during acute COVID infection 37 Slower virus clearance associates with greater risk of long COVID Herbert, C., et al., Poster 0935, 2025 Conference on Retroviruses and Opportunistic Infection (CROI) Days after Peak Viral Load Modeled
Slide 38: Symptoms associated with the risk of Long COVID
Long COVID associates with slow viral clearance and viral rebound during acute SARS - CoV - 2 infection 38 Symptoms associated with the risk of Long COVID Herbert, C., et al., Poster 0935, 2025 Conference on Retroviruses and Opportunistic Infection (CROI)
Slide 39: Consistent high plasma drug levels could allow protection against new variants
Consistent high plasma drug levels could allow for protection against new variants 39 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) 110 nM (13xEC50) Plasma drug l evels (24 h C trough values
Slide 40: Ratutrelvir has successfully completed Phase 1 studies
40 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 Plan to submit a pre - IND meeting request to align with FDA on Long - COVID endpoints Note: TRAW data on file
Slide 41: Final Remarks
Final Remarks 41 Iain D. Dukes, D Phil Executive Chairman
Slide 42: Key Take Aways
Key Take Aways 42 Source: TRAW data on file. Notes: PK = pharmacokinetics. PAXLOVID® is a registered trademark of Pfizer, Inc. Bird Flu – Tivoxavir marboxil COVID - Ratutrelvir Potent broad resistance profile, including strains resistant to other agents Data in 3 well - accepted bird - flu models co
Slide 43: Outlook on Financials, Market Potential and Milestones
Cash , cash equivalents and short - term investments as of Dec 31, 2024, were $21.3 million 1 Cash position to support planned operations into Q1 2026 Selected Financial Information Anticipated Upcoming Milestones Milestone Program Update on FDA discussions regarding the Animal Rule in Q2 2025 Bird
Slide 44: Q&A
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Slide 45: Thank You!
Thank You! www.trawspharma.com