Executive Summary

Q4 2023 showed disciplined cost control with R&D at $0.30M and G&A at $0.84M, driving net loss to $1.10M or $0.06 per share; no revenue was reported as the company remains development-stage .
Management extended cash runway guidance to funding operations into Q4 2024, up from “into Q3 2024” in the prior quarter, while cash at year-end was $3.32M; liquidity remains a central focus pending external funding or a partnership .
FDA alignment on IMC-2 Long-COVID Phase 2 endpoints (fatigue primary, orthostatic intolerance secondary) was the key qualitative milestone; initiation targeted for H2 2024, contingent on funding, and new placebo-controlled LC data expected this summer .
Partnering discussions for IMC-1 (fibromyalgia) Phase 3 continue; prior communications targeted mid-2024 Phase 3 start post-pK, but the current update emphasizes funding/partner needs, increasing timing uncertainty .
Near-term stock catalysts are tied to LC clinical readout this summer, clarity on IMC-2 Phase 2 financing, and any IMC-1 Phase 3 partnership announcement .

What Went Well and What Went Wrong

What Went Well

FDA endpoint alignment for IMC-2 Phase 2 in Long-COVID: “We are pleased to have recently reached alignment with FDA on using fatigue response as the primary end point...” (Greg Duncan, CEO) .
Operating discipline: Q4 R&D fell to $0.30M vs. $1.27M YoY, G&A held flat at ~$0.84M, reducing net loss to $1.10M from $2.04M YoY .
Liquidity guidance improved: runway now “into the fourth quarter of 2024,” up from “into Q3 of 2024” the prior quarter, supporting ongoing development milestones .

What Went Wrong

No revenue generation and continued net losses: Q4 2023 revenue was $0, net loss $1.10M, highlighting dependence on external funding or partnerships to advance programs .
Increasing reliance on external funding/partners for program starts: IMC-2 Phase 2 and IMC-1 Phase 3 timelines now explicitly contingent on financing/partnering, elevating execution risk .
Cash declined to $3.32M at year-end from $4.79M at Q3 and $4.59M at Q2, underscoring urgency for capital solutions despite extended runway guidance .

Financial Results

Metric	Q2 2023	Q3 2023	Q4 2023
Revenue ($USD Millions)	$0.00	$0.00	$0.00
R&D Expense ($USD Millions)	$0.56	$0.37	$0.30
G&A Expense ($USD Millions)	$0.92	$0.90	$0.84
Total Operating Expenses ($USD Millions)	$1.48	$1.27	$1.14
Loss from Operations ($USD Millions)	$(1.48)	$(1.27)	$(1.14)
Other Income ($USD Millions)	$0.04	$0.04	$0.03
Net Loss ($USD Millions)	$(1.44)	$(1.24)	$(1.10)
Diluted EPS ($USD)	$(0.08)	$(0.06)	$(0.06)
Weighted Avg Shares (Millions)	18.41	19.09	19.26
Cash and Equivalents ($USD Millions)	$4.59 (as of 6/30/23)	$4.79 (as of 9/30/23)	$3.32 (as of 12/31/23)

Q4 YoY Comparison	Q4 2022	Q4 2023
R&D Expense ($USD Millions)	$1.27	$0.30
G&A Expense ($USD Millions)	$0.82	$0.84
Net Loss ($USD Millions)	$(2.04)	$(1.10)
Diluted EPS ($USD)	$(0.11)	$(0.06)

Segment breakdown: Not applicable; no commercial revenue reported .

KPIs: Cash runway guidance “into Q4 2024” and cash of $3.32M at 12/31/23 .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Operating runway	Into Q3 2024	Into Q4 2024	Raised
IMC-1 (Fibromyalgia) Phase 3 Start	Timing	Begin enrollment mid-2024 post-pK	Discussions ongoing with partners to fund advancement; timing contingent on funding	Shifted to funding-contingent (lower visibility)
IMC-2 (Long-COVID) Phase 2 Initiation	Timing	Planned to meet FDA in H2 2023; proposal to advance IMC-2 to Phase 2	Targeted H2 2024 initiation, contingent on funding; endpoints aligned (fatigue primary, orthostatic intolerance secondary)	Formalized timing with funding contingency; endpoints aligned
LC Study Readout (Bateman Horne Center)	Data timing	Planning second double-blind, placebo-controlled study in fall 2023	New 12-week placebo-controlled data expected this summer	Concrete near-term readout window

Earnings Call Themes & Trends

Note: No Q4 2023 earnings call transcript is available in the document catalog; Q3 call details were announced but the Q3 transcript could not be retrieved due to a database inconsistency .

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2023)	Trend
Regulatory/FDA	FDA indicated toxicology program appears adequate for IMC-1 safety; planned pK study and Phase 3 outline submission (Q2) . Secured FDA guidance to progress IMC-1 Phase 3; submitted briefing materials for IMC-2 IND (Q3) .	FDA agreed fatigue as primary endpoint and orthostatic intolerance key secondary for IMC-2 Phase 2 in LC .	Positive regulatory clarity for LC; continued engagement across programs
R&D Execution	pK study planned; IMC-2 second placebo‑controlled LC study planned (Q2) .	Lower R&D spend with pipeline progression and prudent expense management (Q3) .	R&D spend down with focused milestones; execution aligned to financing
Funding/Liquidity	ATM Sales Agreement executed; cash believed sufficient for at least next 12 months (Q2) .	Runway into Q3 2024 (Q3) .	Runway extended into Q4 2024 (Q4) .
Partnerships	Phase 3 engagement with multiple life science companies reviewing data/program (Q3) .	Discussions ongoing to fund IMC-1 Phase 3 .	Continued pursuit; timing contingent on deal
Long‑COVID Program	Planning to sponsor second double‑blind LC study and meet FDA re: Phase 2 (Q2) .	Submitted briefing materials for IMC‑2 IND (Q3) .	Endpoints aligned; Phase 2 targeted H2 2024 contingent on funding; placebo‑controlled data expected this summer .

Management Commentary

“We are pleased to have recently reached alignment with FDA on using fatigue response as the primary end point for evaluating IMC-2 as a treatment for Long-COVID symptoms.” — Greg Duncan, Chairman & CEO, Virios Therapeutics .
“This is particularly encouraging given that our unique combination antiviral agents have demonstrated clinically and statistically significant improvement in patient fatigue in several studies, including for IMC-2 treated Long-COVID patients.” — Greg Duncan .
“As the scientific community becomes more knowledgeable about the effects of reactivated viruses and the resulting morbidities on the human body, we believe that Virios is well positioned ... to advance both IMC-1 and IMC-2 as potential treatments...” — Greg Duncan (Q3 2023) .

Q&A Highlights

No Q4 2023 earnings call transcript was found in the catalog; accordingly, no Q&A content is available for this period .

Estimates Context

Wall Street consensus estimates (S&P Global) for Q4 2023 EPS and revenue were unavailable for VIRI due to missing mapping in the SPGI CIQ company map. As such, no estimate comparison is provided [GetEstimates error].
Given VIRI’s development-stage status with zero revenue, near-term estimate frameworks (EPS/revenue) are less informative than milestone/financing timing; future comparisons should focus on clinical catalysts and cash runway .

Key Takeaways for Investors

Regulatory milestone: FDA endpoint alignment for IMC-2 LC Phase 2 materially de-risks trial design; near-term Bateman Horne placebo-controlled LC data this summer is a tangible catalyst .
Liquidity: Runway extended to Q4 2024, but absolute cash declined to $3.32M at year-end; partnering or capital raise remains pivotal for program initiation timelines .
Program timing: IMC-2 Phase 2 targeted for H2 2024 contingent on funding; IMC-1 Phase 3 advancement now explicitly linked to partner funding, shifting timing visibility from prior mid-2024 expectations .
Cost discipline: Sustained low R&D and stable G&A reduced net loss run-rate; operating efficiency supports optionality while management pursues financing/partnerships .
Trading setup: Expect stock to react to LC data readout and any partnership/financing announcements; absence of revenue keeps attention on clinical/regulatory news flow .
Medium-term thesis: If IMC-2 LC data are supportive and Phase 2 launches, VIRI’s LC program could gain strategic value; IMC-1’s Fast Track status and Phase 3 readiness may attract partners if funding terms are workable .
Risk management: Financing execution risk is central; investors should monitor cash updates, ATM usage, and partner negotiations alongside trial progress .

Virios Therapeutics, Inc. (VIRI)·Q4 2023 Earnings Summary