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Traws Pharma announces antiviral program targeting Hantavirus and Ebola outbreaks
Novel dual-strike combination agent exploits host nucleotide depletion and forced incorporation to halt viral replication.
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Traws Pharma Q1 net loss $7.1M; secures up to $60M PIPE financing
Net loss of $7.1M ($0.53/share) vs net income of $21.5M in Q1 2025; revenue $0.
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Traws Pharma announces $10M PIPE (up to $60M with warrants) to fund UK flu challenge trial
Upfront gross proceeds of $10M from sale of ~5.98M shares at $1.6730/share; warrants could add $50M.
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Traws Pharma FY2025 net income $9.2M (vs loss $166.5M); $60M PIPE with $10M upfront funds into Q1 2027
FY2025 net income $9.2M ($0.83 basic EPS) vs net loss $166.5M ($35.21 loss/share) in FY2024; revenue $2.8M (up from $0.2M).
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Traws Pharma: ratutrelvir Phase 2 shows fewer AEs, faster symptom resolution; FDA hold on tivoxavir IND
Ratutrelvir Phase 2: 10% vs 23.3% adverse events, faster symptom resolution (HR 1.31, p=0.018), no viral rebound vs PAXLOVID.
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Traws Pharma files IND for flu drug TXM; ratutrelvir beats Paxlovid on symptom resolution in interim study
IND filed with FDA for tivoxavir marboxil (TXM) for influenza; final step for BARDA stockpile consideration.
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Traws Pharma ratutrelvir shows fewer adverse events and no viral rebound in interim Phase 2 COVID-19 data vs PAXLOVID
Interim analysis of 37 patients: 25 on ratutrelvir 600 mg once daily 10 days, 12 on PAXLOVID 5-day regimen.
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Traws Pharma reports Q3 net loss $4.0M; Phase 2 ratutrelvir data expected YE 2025
Net loss of $4.0M ($0.34 diluted EPS) vs $8.5M ($1.49) in Q3 2024; R&D and G&A expenses down significantly.
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Traws Pharma doses first subject in Phase 2 COVID study of ratutrelvir; top-line data by year-end 2025
First subject dosed in Phase 2 study of ratutrelvir, a ritonavir-free anti-viral for newly diagnosed COVID.
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Traws Pharma gets HREC approval for Phase 2 COVID trials of ratutrelvir; top-line data expected year-end 2025
First Phase 2 non-inferiority trial compares ratutrelvir 600 mg QD for 10 days vs PAXLOVID 5-day regimen in newly diagnosed COVID subjects.
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Traws Pharma Q2 net loss narrows to $0.9M; cash drops to $13.1M; Phase 2 COVID study planned
Net loss of $0.9M ($0.11/share) vs. $123.1M loss in Q2 2024 which included $117.5M acquisition charge.
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Traws Pharma submits Phase 2 protocols for bird flu and COVID drugs; requests FDA meeting
Submitted HREC Phase 2 protocol for tivoxavir marboxil (TXM) to treat H5N1 bird flu and seasonal influenza.
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Traws Pharma reports 80% ORR, 50% CR for rigosertib in RDEB-SCC Phase 2 study
Rigosertib Phase 2 ISS in RDEB-SCC showed 80% overall response rate (ORR) with 50% complete responses (CR) in evaluable patients.
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Traws Pharma gets FDA guidance on bird flu drug tivoxavir; details stockpiling plans; cash $15.9M
Received FDA guidance on path forward for tivoxavir marboxil (TXM) for bird flu and seasonal flu; pursuing Animal Rule for accelerated approval.
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Traws Pharma corporate deck touts bird flu TXM data, COVID plans, $15.9M cash
TXM bird flu: 100% survival in mice, dose-dependent survival in ferrets; single dose maintained plasma >EC90 for ~3 weeks in Phase 1.
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Traws Pharma Q1 net income $21.5M on warrant gain; cash $15.9M; CEO transition
Net income of $21.5M ($2.17 basic EPS) driven by $26.5M gain from warrant liability fair value change; revenue $57K.
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Traws Pharma reports FY2024 net loss of $166.5M; CEO Werner Cautreels retiring, Iain D. Dukes Interim CEO
Net loss of $166.5M ($35.21/share) for FY2024, driven by $117.5M acquired IPR&D and $24.4M warrant expense.
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CEO Werner Cautreels retiring; Iain Dukes appointed Interim CEO effective March 31, 2025
Werner Cautreels to retire as CEO effective upon filing 2024 10-K around March 31; remains on board and as special advisor.
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Traws Pharma reports positive Phase 1 data for COVID-19 drug ratutrelvir; no ritonavir needed
Phase 1 data at 600 mg/day for 10 days show trough blood levels ~13x EC50 and >EC90 for 2 days post-treatment.
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Traws Pharma: TXM shows positive H5N1 data in non-human primates; FDA meeting planned H1 2025
Single-dose TXM (480 mg) reduced lung viremia below quantitation vs up to 1x10^7 in controls after H5N1 challenge.
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Traws Pharma tivoxavir marboxil shows 100% survival in H5N1 rodent model; Phase 1 PK positive
100% of TXM-treated mice survived lethal H5N1 challenge; all untreated controls died by study day 6.
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Traws Pharma enters ATM equity facility for up to $50M with Citizens JMP Securities
ATM agreement allows sale of common stock up to $50M aggregate, subject to baby shelf limit of $5,514,200.
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Traws Pharma reports positive H5N1 ferret model data for tivoxavir marboxil
Single oral dose of tivoxavir marboxil increased survival and reduced viral burden in lungs and nasal tissues in ferrets.
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Traws Pharma regains Nasdaq compliance with $2.5M equity rule; under monitoring until Feb 2026
Received Nasdaq confirmation on Feb 25, 2025 of compliance with minimum $2.5M stockholders' equity requirement.
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Traws Pharma CFO Mark Guerin resigns; Nora Brennan named Interim CFO
Mark Guerin resigned as CFO effective Feb 5, 2025; receives $250K in 9 monthly installments plus $150K lump sum.
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Traws Pharma completes Phase 1 studies for single-dose bird flu drug tivoxavir marboxil
Phase 1 trial showed safety, tolerability, and PK supporting dosing for H5N1 treatment and prevention.
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Traws Pharma raises up to $72.6M; initial $20M tranche to fund Bird Flu drug
Initial $20M gross proceeds from common stock and pre-funded warrants; net proceeds ~$17.9M.
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Traws Pharma receives Nasdaq delisting notice for equity-rule non-compliance
Nasdaq Staff notified Company on Nov 20, 2024 of non-compliance with $2.5M stockholders' equity requirement (Listing Rule 5550(b)(1)).
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Traws Pharma Q3 net loss $8.5M; cash $5.4M; Phase 2 starts for COVID and flu drugs in 2025
Net loss of $8.5M ($8.81 per share) vs $4.7M loss in Q3 2023; R&D expense $5.1M, G&A $3.5M.
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Traws Pharma regains bid price compliance but remains at risk of delisting due to equity deficit
Regained compliance with Nasdaq minimum bid price requirement as of Oct 29, 2024 after 10 consecutive business days above $1.00.
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Traws Pharma receives Nasdaq delisting notice; will request hearing to regain compliance
Received delisting determination from Nasdaq on Sept 24, 2024 for failing to maintain minimum $1 bid price.
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Traws Pharma approves 1-for-25 reverse stock split, regains Nasdaq equity compliance
Board approved 1-for-25 reverse split; effective Sept 20, trading split-adjusted Sept 23.
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Traws Pharma receives Nasdaq delisting notice for stockholders' deficit of $105.5M
Received Nasdaq letter on Aug 21, 2024 for non-compliance with minimum $2.5M stockholders' equity.
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Traws Pharma reports Q2 net loss of $123.1M; $16.9M cash; pipeline milestones ahead
Net loss of $123.1M ($4.87 per share) includes $117.5M non-cash charge from acquired in-process R&D.
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Traws Pharma appoints KPMG as new independent auditor, replacing Ernst & Young
On July 16, 2024, Traws Pharma's Audit Committee engaged KPMG as its new independent registered public accounting firm for the year ending December 31, 2024.