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Virios Therapeutics, Inc. (VIRI)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 delivered steady operating discipline for a pre-revenue biotech: net loss narrowed to $1.29M (EPS $-0.07) vs $1.52M (EPS $-0.08) in Q1 2023, with total OpEx reduced 16% YoY to $1.31M .
  • Cash was $2.38M at quarter-end; management believes resources are sufficient to fund operations into Q4 2024, but the 10-Q notes substantial doubt about going concern absent additional capital within 3–5 months .
  • LC (IMC-2) program momentum continued: BHC-202 double-blind study passed 50% enrollment with preliminary safety favorable (no SAEs); top-line results expected 2H 2024, a potential stock catalyst .
  • Nasdaq minimum bid price deficiency triggered a hearings process; Virios will present a remediation plan (including reverse split if necessary) at a June 18, 2024 panel hearing, adding listing risk near-term .
  • No revenue and no formal financial guidance; operating trajectory depends on clinical readouts and partnership progress (IMC-1 Phase 3 in FM) .

What Went Well and What Went Wrong

  • What Went Well

    • BHC-202 LC study enrollment surpassed 50% with favorable preliminary safety (no Serious Adverse Events), keeping the 2H 2024 top-line timeline on track; “We believe IMC-2 has the potential to provide a needed treatment option for Long-COVID symptoms” — Greg Duncan, CEO .
    • Operating discipline: OpEx fell to $1.31M vs $1.56M YoY; R&D down to $0.34M and G&A down to $0.97M, narrowing net loss and EPS vs prior year .
    • Global patent publication for IMC-2 (LC and Alzheimer’s) streamlines global IP prosecution, strengthening the LC program’s asset value .
  • What Went Wrong

    • Cash declined to $2.38M with the 10-Q flagging substantial doubt around going concern without new funding in the next 3–5 months, elevating financing risk .
    • Nasdaq bid-price non-compliance persists; shares remain subject to delisting pending a June 18 panel, potentially necessitating a reverse split .
    • Still no revenue and limited external coverage/consensus estimates; execution remains dependent on clinical data and partnership for IMC-1 Phase 3 in FM .

Financial Results

MetricQ1 2023Q4 2023Q1 2024
Revenue ($USD Millions)$0.00 $0.00 $0.00
Total Operating Expenses ($USD Millions)$1.56 $1.14 $1.31
R&D Expense ($USD Millions)$0.50 $0.30 $0.34
G&A Expense ($USD Millions)$1.06 $0.84 $0.97
Loss from Operations ($USD Millions)$(1.56) $(1.14) $(1.31)
Other Income ($USD Millions)$0.04 $0.03 $0.02
Net Loss ($USD Millions)$(1.52) $(1.10) $(1.29)
Diluted EPS ($USD)$(0.08) $(0.06) $(0.07)
Cash and Equivalents ($USD Millions)$5.33 $3.32 $2.38

Notes:

  • Operates in one segment as a pre-revenue development-stage biotech .

KPIs

KPIQ1 2023Q4 2023Q1 2024
Operating Cash Used ($USD Millions)$(1.70) N/A$(0.94)
BHC-202 LC Study EnrollmentN/AN/A≥50%
BHC-202 Preliminary Safety (SAEs)N/AN/ANone reported
Nasdaq Hearing StatusN/AN/AHearing set June 18, 2024

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayFY 2024“Capital to support operations into Q4 2024” (as of Q4 2023) “Sufficient resources to fund operations into Q4 2024” Maintained
LC (IMC-2) Phase 2 Program Initiation2H 2024Targeted for 2H 2024, contingent on funding Plans include potential IND submission; BHC-202 top-line 2H 2024 Maintained/clarified
FM (IMC-1) Phase 3 Advancement2024+Ongoing partner discussions Ongoing partner discussions Maintained
Nasdaq Listing Compliance PlanMid-2024Not disclosed priorHearing requested; plan includes potential reverse split if necessary New disclosure

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023, Q4 2023)Current Period (Q1 2024)Trend
LC Program (IMC-2)FDA alignment on LC endpoints; IND materials submitted; IP filed; 12-week placebo-controlled data expected summer 2024 BHC-202 enrollment ≥50%; preliminary safety favorable; top-line 2H 2024; global patent published Improving execution; near-term data catalyst
FM Program (IMC-1)Secured FDA guidance for Phase 3; multiple life sciences companies reviewing for potential partnership Discussions ongoing to seek a partner for Phase 3 FM Ongoing; partner optionality remains
Regulatory/ListingNasdaq hearings process initiated; reverse split option if needed Deteriorating listing optics; remediation in process
R&D Execution/OpExR&D and G&A down vs prior periods; runway into Q3/Q4 2024 Continued OpEx control; net loss narrowed YoY; runway into Q4 2024 Maintained discipline
Financing/RunwayCash $4.8M (Q3 2023) and $3.3M (Q4 2023); runway guidance Cash $2.38M; 10-Q highlights need to raise capital in 3–5 months Tightening liquidity; financing need increasing

Management Commentary

  • “Every week new scientific research highlights the emergence of Long-COVID as a major unmet medical need… We believe IMC-2 has the potential to provide a needed treatment option for Long-COVID symptoms and look forward to sharing results from the ongoing BHC study… later this year.” — Greg Duncan, Chairman & CEO .
  • “Discussions are ongoing as we seek a partner to advance IMC-1… into Phase 3 development for the treatment of FM.” .
  • “The Company believes it will have sufficient resources to fund operations into the fourth quarter of 2024.” .
  • 10-Q added: “The Company will need to raise additional capital within the next three to five months… Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern…” .

Q&A Highlights

  • The Q1 2024 earnings call was held on May 9, 2024 at 8:30 a.m. ET; however, the full transcript was not retrievable from the document repository due to a database inconsistency, and thus specific Q&A themes cannot be reliably summarized from primary sources .
  • External links referencing the transcript exist (e.g., Seeking Alpha, Yahoo Finance), but we did not use them as primary sources for Q&A details in this recap to maintain source integrity .

Estimates Context

  • S&P Global (Capital IQ) consensus estimates were unavailable for VIRI this quarter via our SPGI connection; as a pre-revenue micro-cap, coverage is limited. Therefore, comparisons vs Wall Street consensus could not be included, and no estimate-driven beats/misses are presented [GetEstimates error: SpgiEstimatesError].
  • Third-party aggregators indicate EPS consensus around $-0.08 and actual EPS $-0.07 (a beat), but we did not rely on non-S&P sources for this recap per guidelines .

Key Takeaways for Investors

  • Near-term catalyst: BHC-202 LC Phase 2 top-line results expected 2H 2024; early safety is clean (no SAEs), increasing the probability of a value-creating data event .
  • Liquidity risk elevated: cash $2.38M and 10-Q indicates capital must be raised within 3–5 months to sustain operations; watch for financing announcements and terms .
  • Listing overhang: Nasdaq hearing on June 18, 2024; a reverse split may be required to regain compliance, potentially impacting trading dynamics .
  • Operating discipline continues: OpEx fell YoY, narrowing net loss and EPS; however, with no revenue, sustainable funding remains the core driver .
  • Partnering is pivotal: IMC-1 Phase 3 in FM depends on securing a partner; IMC-2 LC advancement benefits from global IP publication and FDA feedback .
  • Actionable setup: Trade around LC data timing and listing outcomes; medium-term thesis hinges on clinical validation of IMC-2 and strategic deals for IMC-1 .
  • Monitor cash burn and runway updates in upcoming filings; any change to “into Q4 2024” guidance or financing terms will move the stock .

Appendices

Other relevant Q1 2024 press release references:

  • Company announcement of Q1 reporting schedule (context, non-primary): “to report First Quarter 2024 Financial Results on May 9, 2024” .

Primary source documents read:

  • Q1 2024 8-K and Exhibit 99.1 press release (financial results and corporate update) .
  • Q1 2024 10-Q (financial statements, going concern, Nasdaq process, program updates) .
  • Prior quarters’ 8-K press releases: Q4 2023 (financial results, LC Phase 2 planning) , Q3 2023 (financial results, IMC-1 Phase 3 partnering) .