Traws Pharma, Inc. · NASDAQ:TRAW
Traws Pharma — Investor Presentation (May 2025)
45 slides from Traws Pharma's investor presentation, May 19, 2025
Slide 1: Corporate Presentation May 2025
NASDAQ: TRAW May, 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 1 ) and then develop as best - in - class seasonal flu therapy Potential best - in - class COVID
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 changes in virus strain 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
Slide 5: High-Potential Antiviral Pipeline Focused on Critical Threats
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/Seasonal flu Tivoxavir marboxil • Demonstrated supp
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 Influenza – Tivoxavir marboxil (TXM) COVID - Ratutrelvi
Slide 7: Selected Financial Information and Anticipated Upcoming Milestones
Bird Flu: In short term, strategic stockpile approx. 300,000,000 - 600,000,000 doses . Seasonal Flu: Potential best in class agent to replace existing therapies addressing emerging resistant strains COVID: Potential b est - in - class agent to replace existing therapies, and prevent clinical rebound
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 Nora Brennan Interim Chief Financial Officer Board of Directors Nikolay Savchuk, PhD Chief Operating Officer, Director Chairman Jack E. Stover Interim
Slide 9: 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 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 10 Major and increasing agricultural impact of bird flu No bird flu therapies approved today 4 5 High historical human mortality from bird flu, with human pandemic potential 1 L imited
Slide 11: Tivoxavir Marboxil: Value Proposition for Bird Flu
Tivoxavir Marboxil (TRX100/TXM): Value Proposition for Bird Flu 11 Differentiating features of TXM, a potent oral antiviral drug A single dose reduced disease and prevented death in 3 preclinical animal models used commonly in flu drug development, with large reductions in lunf g virus levels and lu
Slide 12: Tivoxavir Potently Inhibits Highly Pathogenic Avian Influenza Viruses
Tivoxavir Potently Inhibits Highly Pathogenic Avian Influenza Viruses 12 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 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® ) 13 Nine Mutations in A/Texas/37/2024 were Not Present in the Bovine Isolate O
Slide 14: 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 14 Notes: Challenge dose via intranasal delivery. TXM = tivoxavir marboxil, 5 animals per group sacrificed on D3 for determinati on of virus titer in lungs (data pending). Data on file, TRAWS Pharma. Virus Challeng
Slide 15: TXM Achieved Complete Viral Clearance in the Lung
15 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 16: Virus Challenge Study in Ferrets
Virus Challenge Study in Ferrets: Key Data to Support Clinical and Regulatory Strategy for TXM 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 viral inoculation for lung virus
Slide 17: 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 17 Note: TRAW data on file. intranasal challenge/inoculation. Virus challenge stock: A/Texas/37/2024 (H5N1); 4 animals per group sa crificed at
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 afte
Slide 20: 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 20 Note: TRAW data on file. intranasal challenge/ino
Slide 21: 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 21 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 22: 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 22 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 23: 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) 23 Note: TRAW data on file. Virus challenge stock: A/Texas/37/2024 (H5N1); 5 animals per group Treated Untreated control
Slide 24: 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 25: TXM Treatment Reduced Lung Pathology in Nonhuman Primates
Tivoxavir Marboxil Treatment Reduced Lung Pathology in Nonhuman Primates Infected with Bird Flu Virus 25 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 26: Phase 1 Study Design for TXM
Phase 1 Study Design for TXM 26 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 continued until 28 days after dosing. Eligibilit
Slide 27: 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) 27 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 28: Pre-IND Meeting Request Submitted March 21, 2025
Pre - IND Meeting Request Submitted March 21, 2025 28 Meeting granted; briefing package provided to FDA on April 24, 2025 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 ▪ Animal Rule int
Slide 29: 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. 1. TRAW i nformation TXM Could Be a Fit f
Slide 30: Seasonal Influenza: Tivoxavir marboxil (TXM, TRX100)
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 Today 1 31 Seasonal variation necessitates continual development of vaccines and vaccines provide incomplete protection and have limited utilization Antiviral drugs attack highly conserved targets that are not subject to seasonal variation 5 Influenz a
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 33 Expected to enroll ~30 influenza - positive subjects 18 - 65 years of age in the US and Australia Expected to incorporate two dosing groups (n=30 each): • Selected TXM dose • Standard of care Evaluate a single dose of TXM and assess time to symptom relief, safet
Slide 34: COVID: Ratutrelvir (TRX01)
34 COVID - 19 Ratutrelvir (TRX01) Investigational Main protease (Mpro) inhibitor Ritonavir - independent,10 - day, single pill, once - daily dosing regimen
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/burde n - e stimates.html. Long
Slide 36: 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 36 Symptoms associated with the risk of Long COVID 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 37 Increasing clinical and economic burden of Long COVID Current approved antiviral, PAXLOVID®, is contra - indicated in vulnerable populations, including the elderly and the immunocompromi
Slide 38: Ratutrelvir Value Proposition for COVID/Long COVID
Ratutrelvir Value Proposition for COVID/Long COVID 38 Differentiating features of ratutrelvir, a potent oral antiviral agent Dose at RP2D maintains favorable PK, with plasma drug levels at ~110X the EC 9 0, and higher concentrations in lung compared to blood Broadly more active against original COVI
Slide 39: Ratutrelvir is Consistently More Potent than Competitor Agents
Ratutrelvir is Consistently More Potent than Competitor Agents in Suppression of COVID in vitro 39 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 concentration for 50% i
Slide 40: Ratutrelvir is Active Against Viruses with Acquired Resistance
Ratutrelvir is Active Against Viruses with Acquired Resistance to PAXLOVID® or Ensitrelvir 40 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 al., (2025). "E
Slide 41: Phase 1 MAD Results: Daily Oral 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) 41 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 42: Consistent High Plasma Drug Levels Could Allow Protection Against New Variants
Consistent High Plasma Drug Levels Could Allow for Protection Against New Variants 42 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 43: Ratutrelvir has Successfully Completed Phase 1 Studies
43 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 preve
Slide 44: Targeting Critical Viral Threats to Human Health
Targeting Critical Viral Threats to Human Health 44 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 1 ) and then develop as best - in - class seasonal flu therapy Potential best - in - class COVI
Slide 45: Thank You!
Thank You! www.trawspharma.com