Executive Summary

Q1 2025 revenue was $0.06M and GAAP net income was $21.49M, driven by a $26.51M non‑cash gain from remeasurement/reclassification of warrant liabilities; operating loss remained ~$5.2M as R&D ramped on virology programs .
Cash and equivalents were $15.94M at quarter‑end; management disclosed cash runway “into Q1 2026,” but the 10‑Q reiterates substantial doubt about going concern absent additional financing (ATM in place) .
Regulatory catalysts: FDA briefing package submitted Apr 24, 2025 for tivoxavir marboxil (TXM) to discuss Animal Rule accelerated approval; ratutrelvir COVID program briefing planned for Q2 2025 .
Q1 updates highlighted positive preclinical TXM data (NHP and ferret challenge models) and Phase 1 PK profiles (single‑dose persistence above EC90), plus leadership changes (Interim CEO, Interim CFO) and regained Nasdaq equity compliance monitoring status .

What Went Well and What Went Wrong

What Went Well

Advancing regulatory path: TXM FDA briefing package submitted (Apr 24) to align on potential Animal Rule accelerated approval; ratutrelvir regulatory briefing planned Q2 2025 .
Compelling TXM data: Single‑dose reduced lung viral burden/pathology in NHPs and improved survival/lowered viral burden in ferrets; Phase 1 PK supports single‑dose use with plasma levels >EC90 for ~3 weeks .
Management continuity and efficiency: G&A decreased 18% YoY; leadership transitions executed (Interim CEO, Interim CFO); Nasdaq equity compliance regained (panel monitor in place) .

“Identifying opportunities to accelerate the path to approval is core to Traws’ strategy…We look forward to providing an update…over the next quarter.” — Iain D. Dukes, Interim CEO .
“We believe that Traws’ programs are each poised to make important progress in the coming months…” — Robert Redfield, MD, CMO .

What Went Wrong

Minimal operating revenue and continued operating losses: $0.06M revenue; loss from operations ~$5.20M as R&D increased on virology programs; profitability driven by non‑cash warrant liability change rather than operations .
Liquidity risk persists: Despite “runway into Q1 2026,” the 10‑Q states substantial doubt about going concern; company needs additional dilutive/non‑dilutive funding (ATM active; strategic options) .
Program dependence on regulatory outcomes: TXM’s potential Animal Rule path and ratutrelvir’s clinical path are binary catalysts; CMC scale‑up and formulation work still ahead, and clinical POC remains to be demonstrated .

Financial Results

Income Statement (selected metrics)

Metric	Q1 2024	Q3 2024	Q1 2025
Revenue ($USD)	$0.06M	$0.06M	$0.06M
Research & Development Expense ($USD)	$1.91M	$5.11M	$2.51M
General & Administrative Expense ($USD)	$3.36M	$3.48M	$2.75M
Total Operating Expenses ($USD)	$5.27M	$8.59M	$5.26M
Loss from Operations ($USD)	$(5.21)M	$(8.54)M	$(5.20)M
Change in FV of Warrant Liability ($USD)	—	—	$26.51M
Net Income (Loss) ($USD)	$(4.98)M	$(8.48)M	$21.49M
EPS Basic ($)	$(5.92)	$(8.81)	$2.17
EPS Diluted ($)	$(5.92)	$(8.81)	$2.09

Notes: Q1 2025 profitability reflects a non‑cash $26.51M fair value gain and reclassification of warrant liabilities; core operating loss persisted .

Balance Sheet (key items)

Metric	Dec 31, 2024	Mar 31, 2025
Cash & Cash Equivalents ($USD)	$21.34M	$15.94M
Warrant Liabilities ($USD)	$42.49M	$0.15M
Total Liabilities ($USD)	$56.59M	$13.06M
Stockholders’ Equity (Deficit) ($USD)	$(31.63)M	$6.00M

Cash Flow / KPIs

KPI	Q1 2025
Net Cash Used in Operating Activities ($USD)	$(5.44)M
Shares Outstanding (as of 5/13/25)	5,564,315
Cash Runway (company statement)	Into Q1 2026
Going Concern (GAAP disclosure)	Substantial doubt without new financing

Estimates vs Actuals (S&P Global)

Metric	Q1 2025 Consensus	Q1 2025 Actual
Revenue ($USD)	N/A*	$57,000
Primary EPS ($)	N/A*	$2.17 basic; $2.09 diluted

*Values retrieved from S&P Global; consensus not available for this issuer/period via our feed.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Not disclosed previously	“Into Q1 2026”	Initiated
TXM Regulatory Path	2025	Planned Phase 2 (Q3’24 update)	FDA briefing submitted Apr 24; Animal Rule pathway under discussion	Formalized FDA engagement
Ratutrelvir Regulatory Plans	2025	Phase 2 initiation planned (Q3’24)	Regulatory briefing planned Q2 2025 for acute/rebound prevention and Long COVID	Timing clarified
Revenue Outlook	2025	Not provided	Not provided	Maintained no guidance

No quantitative revenue/EPS/OpEx guidance was issued; SymBio license termination post‑quarter triggers recognition of ~$2.73M deferred revenue in April 2025 (Q2) .

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was located in our document set.

Topic	Previous Mentions (Q‑2: Q3 2024)	Previous Mentions (Q‑1: Q4 2024)	Current Period (Q1 2025)	Trend
Regulatory path (TXM)	Phase 1 PK supports single‑dose; Phase 2 planned 2025	N/A	FDA briefing submitted; Animal Rule accelerated approval dialogue initiated	Accelerating/regulatory clarity improving
Ratutrelvir strategy	Monotherapy without ritonavir; lower rebound risk; Phase 2 planned	N/A	Regulatory briefing planned Q2 2025 (acute, rebound prevention, Long COVID); PK supports ritonavir‑independent dosing	Advancing toward regulatory alignment
Virology data	PK above EC90; lung accumulation data	N/A	TXM single‑dose efficacy in NHP/ferret models; Phase 1 PK >EC90 ~3 weeks	Strengthening dataset
Financing/listing	Reverse split; microcap pressures; no compliance	N/A	ATM established; Nasdaq equity compliance regained (monitoring)	Improved listing posture; funding optionality
Oncology legacy	IST/partnering focus	N/A	Seeking partnerships for narazaciclib & rigosertib	De‑prioritized; partnership‑driven

Management Commentary

“We have submitted briefing materials to the FDA for our tivoxavir marboxil program, in preparation for a meeting to discuss the potential for accelerated approval under the FDA Animal Rule…We look forward to providing an update…over the next quarter.” — Iain D. Dukes, Interim CEO .
“We believe that Traws’ programs are each poised to make important progress in the coming months, supported by potent antiviral activity… and promising pharmacokinetic profiles from Phase 1 studies, that could enable differentiated activity.” — Robert Redfield, MD, CMO .
TXM highlights: TXM single‑dose significantly reduced lung viral burden/pathology in NHPs; increased survival and reduced viral burden/pathology in ferrets; Phase 1 showed plasma levels above EC90 for ~3 weeks supporting single‑dose treatment .

Q&A Highlights

No Q1 2025 earnings call transcript was available in our corpus; therefore, no Q&A themes to report.

Estimates Context

S&P Global consensus for Q1 2025 EPS and revenue was not available for TRAW via our feed; thus, no beat/miss determination versus Street can be made for EPS or revenue. Actuals reported: revenue $0.06M; EPS $2.17 basic / $2.09 diluted (non‑operating warrant revaluation drove profitability) .
Forward datapoint: As a subsequent event, the company will recognize ~$2.73M of deferred revenue in April 2025 from the SymBio license termination, which will inflate Q2 revenue mechanically; this is not an operating revenue inflection .

Key Takeaways for Investors

Near‑term binary regulatory catalysts: TXM FDA Animal Rule discussion underway; update expected in Q2 2025; ratutrelvir regulatory briefing also planned in Q2—both could drive stock re‑rating depending on feedback .
Cash runway “into Q1 2026” but going‑concern language remains; expect continued financing overhang (ATM active); partnership proceeds or non‑dilutive sources would be positive .
Q1 P&L optics are non‑economic: GAAP net income reflects warrant liability remeasurement and reclassification; focus on operating loss trajectory and cash burn ($5.44M used in operations in Q1) .
TXM and ratutrelvir data readthroughs are encouraging (NHP/ferret efficacy; PK above EC90), supporting differentiated single‑dose and ritonavir‑independent positioning—execution on CMC scale‑up and Phase 2 is the next proving ground .
Listing/compliance stabilized: Nasdaq equity compliance regained with mandatory panel monitoring; governance/management transitions effected without operational disruption .
Watch Q2 optical revenue: ~$2.73M deferred revenue recognition from SymBio termination will lift Q2 revenue but is one‑off accounting, not commercial traction .
Medium‑term thesis hinges on regulatory pathway clarity, Phase 2 execution, and funding strategy; Animal Rule alignment for TXM could materially compress time to potential approval in bird flu settings if supported by data .

Appendices

Additional Business/Program Highlights (Q1 context)

TXM next steps: FDA Animal Rule update in Q2 2025; finalize development plan, formulation, and CMC scale‑up .
Ratutrelvir next steps: Submit regulatory briefing in Q2 2025 for acute treatment/rebound prevention and Long COVID .
Corporate: Interim CEO appointed (Mar 31), Interim CFO appointed (Feb 5), Board Chair transition (Apr 15) .

Prior Quarter Reference (Q3 2024)

Q3 2024: R&D $5.11M; G&A $3.48M; revenue $0.06M; net loss $(8.48)M; Phase 1 PK supported single‑dose TXM and ritonavir‑independent ratutrelvir; Phase 2 studies were anticipated in 2025 .

Traws Pharma, Inc. (TRAW)·Q1 2025 Earnings Summary