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CNS Pharmaceuticals, Inc. (CNSP)·Q2 2023 Earnings Summary

Executive Summary

  • Q2 2023 reflected disciplined OpEx control but continued clinical-trial-driven burn: net loss was $4.021M, up year-over-year ($3.566M) but improved sequentially vs Q1 ($4.932M) as R&D cadence normalized post-Q1 ramp .
  • No product revenue; focus remained on Berubicin’s potentially pivotal GBM study, with ~75% of expected patients enrolled (180 patients, 46 of 60 sites open), and the DSMB-triggering futility criteria reached; topline interim analysis is targeted for Q4 2023 .
  • Liquidity: cash $4.279M and working capital ~$2.074M; management reiterated runway into Q4 2023 through interim topline for Berubicin, while estimating an additional ~$9.1–$13.1M needed to complete the trial and fund near-term WP1244/WP1874 work .
  • Key near-term stock catalyst: 200th patient in Q3 2023 and Q4 2023 interim topline readout; enrollment pace accelerated materially (first 75 patients in 18 months vs second 75 in <6 months) .

What Went Well and What Went Wrong

What Went Well

  • Enrollment acceleration and operational execution: “We are just a few months away from reporting topline results… remain hopeful as we also approach full enrollment of the trial” — John Climaco, CEO; 180 patients enrolled; 46 trial sites opened across U.S. and Europe; futility-analysis criteria reached for DSMB review .
  • Clear milestone path: company reiterated sequence — 200th patient (Q3), interim topline (Q4), complete enrollment (Q4) — tightening the narrative toward clinically meaningful events .
  • G&A efficiency YoY: Q2 G&A decreased to $1.180M from $1.343M, driven by lower compensation, legal/professional, insurance and other expenses .

What Went Wrong

  • Liquidity pressure: cash fell to $4.279M (from $5.111M in Q1), working capital ~$2.074M, implying limited cushion and reliance on external financing to extend runway beyond Q4 2023 .
  • Higher R&D YoY: Q2 R&D rose to $2.846M (from $2.221M YoY) as CRO activity scaled with trial progress; net loss widened YoY to $4.021M .
  • Internal controls: management cited material weaknesses (segregation of duties, timeliness/completeness of CRO cost data, and documentation of control environment), with remediation steps in progress .

Financial Results

MetricQ2 2022Q1 2023Q2 2023
Revenue ($USD Millions)N/A – no revenue line in statements N/A – no revenue line in statements N/A – no revenue line in statements
R&D Expense ($USD)$2,221,339 $3,567,759 $2,845,553
G&A Expense ($USD)$1,343,002 $1,358,752 $1,179,833
Total Operating Expenses ($USD)$3,564,341 $4,926,511 $4,025,386
Net Loss ($USD)$(3,565,952) $(4,931,947) $(4,021,234)
Loss per Share (Basic/Diluted) ($)$(2.67)/$(2.67) $(2.59)/$(2.59) $(1.04)/$(1.04)
Cash and Equivalents ($USD)$8,958,880 (end of Q2 2022) $5,110,531 $4,279,251
Working Capital ($USD)N/A$3,049,000 $2,074,000

Segment breakdown: Not applicable (no commercial segments disclosed) .

KPIs:

KPIQ2 2022Q1 2023Q2 2023
Patients Enrolled (Berubicin Study)N/A“over 100” 180 (~75% of expected)
Trial Sites Open (of 60)N/A45 46
DSMB Futility Criteria ReachedN/AN/AReached; DSMB to review
Expected Interim Topline TimingN/AQ3 2023 Q4 2023
Cash RunwayN/AInto/beyond interim and into Q4 2023 Into Q4 2023 through interim topline

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Interim Topline (Berubicin)2023Q3 2023 Q4 2023 Deferred
200th Patient EnrolledQ3 2023Not specifiedQ3 2023 New specific milestone
Enrollment CompletionQ4 2023Not specifiedQ4 2023 New specific milestone
Cash Runway2023Beyond interim; into Q4 2023 Into Q4 2023 through interim topline Maintained (clarified scope)
Additional Funding Required (clinical + WP1244/WP1874)Multi-period~$15.5–$19.5M to complete Phase 2 (incl. $5.1M cash at Q1) ~$9.1–$13.1M additional to complete clinical trial (incl. $4.3M cash at Q2) Lower range (scope/assumption update)

Earnings Call Themes & Trends

No Q2 2023 earnings call transcript found. Themes derived from press releases and 10-Q/MD&A:

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q2 2023)Trend
R&D Execution & EnrollmentQ1: “over 100 patients” enrolled; rapid site activations; interim in Q3 180 patients (~75% of expected); 46 sites; interim now Q4; futility criteria met Positive momentum; schedule refined
Regulatory/Trial DesignEmphasis on DSMB interim futility analysis and OS primary endpoint in filings DSMB review to confirm value vs Lomustine; Q4 interim target On plan; DSMB milestone reached
Liquidity & FundingQ1: cash $5.111M; working capital $3.049M; runway into/beyond interim Cash $4.279M; working capital ~$2.074M; runway into Q4; additional ~$9.1–$13.1M needed Tightening liquidity; funding gap persists
Corporate GovernanceBoard enhancements (Chair and new independent director) Continued director additions and option grants Strengthening governance
Market/TradingShareholder Intelligence “naked short selling” investigation phase 1 completed; continued monitoring Addressing market-structure concerns

Management Commentary

  • “We are approaching the most important milestone… poised for an exciting remainder of the year with significant milestones anticipated in the near term” — John Climaco, CEO .
  • Enrollment pace “rapidly accelerating” (first 75 patients in 18 months vs second 75 in <6 months) .
  • Cash runway “sufficient to fund operations into the fourth quarter of 2023, through the topline data readout” while acknowledging clinical cost uncertainty .

Q&A Highlights

No Q2 2023 earnings call transcript was available; no Q&A to report [earnings-call-transcript search returned none].

Estimates Context

  • Wall Street consensus (EPS and revenue) via S&P Global was unavailable at time of query due to a daily request limit; therefore, no beat/miss assessment vs estimates can be provided for Q2 2023. If you want, we can reattempt retrieval later for formal comparison [GetEstimates error].

Key Takeaways for Investors

  • Near-term binary catalyst: Q4 2023 interim topline in a potentially pivotal Berubicin GBM study; accelerated enrollment and DSMB futility criteria reached tighten execution credibility .
  • OpEx discipline but continued burn: sequential net loss improved, YoY higher on CRO activity; G&A trending lower YoY reflects cost control .
  • Liquidity limited: cash $4.279M, runway into Q4; additional ~$9.1–$13.1M needed to complete trial and near-term preclinical work; expect financing overhang until data readout .
  • Internal controls remediation underway; watch for progress on CRO reporting timeliness and control documentation as potential governance de-riskers .
  • Stock setup: multiple enrollment and data milestones (Q3/Q4) could drive volatility; interim outcomes likely dominate valuation and financing optionality .
  • No revenue; value is tied to clinical data quality and regulatory pathway; Orphan/Fast Track designations support potential future exclusivity if efficacy demonstrated .
  • Absent consensus data, estimate-based positioning is unclear; re-run estimates closer to events to refine beat/miss probabilities [GetEstimates error].

References: Q2 2023 8-K and press release ; Q2 2023 10-Q ; Q1 2023 8-K press release ; Q1 2023 10-Q .