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CNS Pharmaceuticals, Inc. (CNSP)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 was a tighter-operating quarter: net loss improved to $3.54M from $4.93M YoY on lower CRO spend; R&D fell to $2.43M and G&A to $1.11M .
  • Clinical execution advanced: trial enrollment for potentially pivotal Berubicin in recurrent GBM is complete; DSMB recommended the study continue without modification; topline data targeted for 1H 2025, timing subject to survival events .
  • Balance sheet remains thin: cash was $0.82M at quarter-end and management disclosed a need for ~$13–$15M to complete the Phase 2 plus ~$4.5–$5.0M per year of working capital; cash runway guided only into the latter half of Q2 2024 .
  • Listing risk managed near term: Nasdaq Hearings Panel granted an extension to July 15, 2024 to regain equity and bid-price compliance .
  • Key catalysts: financing and trial continuity; Berubicin topline in 1H 2025; any resolution of IP portfolio actions (HPI license termination notice; potential UTMDACC WP1244 termination) .

What Went Well and What Went Wrong

  • What Went Well

    • Completed enrollment in potentially pivotal Berubicin GBM study; DSMB recommended continuing without modification, supporting risk/benefit to proceed .
    • Operating discipline: R&D declined to $2.43M (from $3.57M YoY) and G&A to $1.11M (from $1.36M YoY), compressing net loss to $3.54M (from $4.93M YoY) .
    • CEO tone remained constructive on value creation: “we continue to plan for success… bring meaningful treatment options to GBM patients as well as value to all stakeholders” (John Climaco) .
  • What Went Wrong

    • Liquidity tightness: cash stood at $0.82M with runway only into the latter half of Q2 2024; company needs ~$13–$15M to complete Phase 2 plus ~$4.5–$5.0M per year operating costs .
    • Listing overhang: required to regain Nasdaq equity and bid-price compliance by July 15, 2024 per Panel extension .
    • IP housekeeping: notice to terminate HPI license (patents expired) and potential termination notice on WP1244 agreement if fees not cured; management does not expect HPI termination to impair Berubicin development but the WP1244 portfolio decision was pending as of Q1 filing .

Financial Results

Quarterly operating profile (oldest → newest)

MetricQ2 2023Q3 2023Q1 2024
Research & Development ($USD Millions)$2.8 $3.4 $2.430
General & Administrative ($USD Millions)$1.2 $1.1 $1.114
Net Loss ($USD Millions)~$4.0 ~$4.5 $3.545
Cash & Equivalents, quarter-end ($USD Millions)$4.3 $0.9 $0.815

Earnings per share and share base (YoY view)

MetricQ1 2023Q1 2024
Diluted EPS (USD)$(2.59) $(0.41)
Weighted Avg Shares (Millions)1.906 8.713

Revenue

MetricQ2 2023Q3 2023Q1 2024
Revenue ($USD Millions)No revenue reported No revenue reported No revenue reported

KPIs and clinical milestones

KPIQ2 2023Q3 2023Q1 2024
Trial enrollment status (Berubicin GBM)~75% enrolled; 46 sites opened of 60 Enrollment 239; 45 sites opened of 60; full enrollment expected Dec-23 Enrollment complete; topline expected 1H 2025
DSMB interim analysis outcomeInterim analysis planned before YE23 Interim analysis outcome pending at time of PR DSMB recommended continue without modification (Dec 18, 2023)

Notes: Q2/Q3 2023 operating figures are rounded as disclosed in press releases; Q1 2024 figures are exact from the 10-Q .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayAs of Q2 2023Sufficient into Q4 2023 Sufficient into latter half of Q2 2024 Raised (extended)
Financing need to complete Berubicin Phase 2ProgramNot specified in prior PRs~$13–$15M to complete trial plus ~$4.5–$5.0M per annum working capital New disclosure
Topline data timing (Berubicin)StudyInterim topline before YE 2023 Final topline in 1H 2025 (timing depends on survival events) Transitioned to final topline window
Nasdaq complianceListingIn violation; cash expected through end Q4 2023 Panel extension to July 15, 2024 to regain equity and bid-price compliance Updated deadline
Authorized sharesCorporateN/AIncreased authorized common shares to 300,000,000 (filed May 2, 2024) Corporate action

Earnings Call Themes & Trends

Note: We did not locate a Q1 2024 call transcript in our document corpus. Themes below reflect disclosures across recent press releases and the Q1 2024 10-Q.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q1 2024)Trend
R&D execution (Berubicin)Q3 2023: 239 patients enrolled; interim analysis expected Dec-23; full enrollment expected Dec-23 . Q2 2023: ~75% enrolled; interim planned before YE23 .Enrollment complete; DSMB recommended continue; topline 1H 2025 .Execution progressing; moved from interim to final data window
Regulatory/designationsFast Track and Orphan Drug highlighted in prior updates .Fast Track and Orphan reiterated .Stable
Liquidity/capitalQ2/Q3 2023 acknowledged limited cash and near-term runways .Runway to mid-Q2 2024; need ~$13–$15M + OpEx to finish trial .Funding need remains the key overhang
Listing compliancePrior: equity/bid-price deficiencies disclosed .Panel extension to July 15, 2024 to regain compliance .Managed near term; monitoring required
IP/portfolioPrior focus on Berubicin; no term notices disclosed .Notice to terminate HPI license (patents expired); WP1244 termination risk if fees uncured .Portfolio rationalization; no impact expected on Berubicin

Management Commentary

  • “With topline results in our ongoing, fully enrolled Berubicin trial for GBM expected in the first half of next year, we continue to plan for success. Our commitment to our dual mission to bring meaningful treatment options to GBM patients as well as value to all stakeholders remains unwavering.” — John Climaco, CEO .
  • On 2023 progress: “we have… reached our pre-planned interim analysis; completed planned enrollment; … and received a recommendation from the DSMB to continue the study without modification, which we believe is a monumental step…” — John Climaco, CEO .

Q&A Highlights

  • We did not find a Q1 2024 earnings call transcript in our corpus; MarketBeat listed a call on May 16, 2024 at 8:00 AM ET, but no transcript was available for review .
  • No additional Q&A clarifications were available beyond disclosures in the 8-K and 10-Q .

Estimates Context

  • We attempted to retrieve S&P Global consensus for Q1 2024 revenue and EPS but were unable to due to session limits; thus we cannot compare actuals to consensus at this time (consensus unavailable). Values would normally be sourced from S&P Global.
  • Actual results: EPS $(0.41) and no revenue were reported for Q1 2024 .
  • Implication: In absence of consensus, sell-side models likely focus on liquidity runway, timing of topline, and dilution risk rather than near-term P&L.

Key Takeaways for Investors

  • Clinical momentum intact: fully enrolled pivotal-style study with DSMB go-forward decision; topline slated for 1H 2025—primary catalyst for the equity story .
  • Funding is the gating factor: runway only into mid-Q2 2024; ~$13–$15M needed to complete Phase 2 plus annual OpEx—expect near-term financing and potential dilution .
  • Listing compliance clock: July 15, 2024 Nasdaq deadline remains a tactical milestone; corporate actions (e.g., share authorization increase) provide optionality .
  • Operating discipline helps but can’t offset cash burn: R&D/G&A declined YoY, trimming net loss to $3.54M, but external capital remains necessary .
  • IP portfolio doesn’t derail Berubicin: HPI license termination notice expected not to affect Berubicin development; WP1244 decision pending—limited near-term impact on the main catalyst path .
  • Trading setup: stock likely trades on financing path/terms and interim clinical updates ahead of topline; positive funding and clean trial execution are key upside drivers; listing non-compliance or strained funding terms are downside risks .

Sources

  • Q1 2024 8-K/Press Release and exhibits: enrollment complete; DSMB continue; financial highlights and cash .
  • Q1 2024 10-Q: full financial statements; EPS; cash flow; liquidity/runway; financing needs; Nasdaq extension; authorized shares; license updates .
  • FY 2023 8-K PR: reiterates DSMB outcome, enrollment completion, and topline timing .
  • Prior-quarter PRs for trend: Q3 2023 and Q2 2023 8-Ks .
  • MarketBeat call listing (no transcript available): .