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Shuttle Pharmaceuticals Holdings, Inc. (SHPH)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 was an operationally focused quarter with FDA “Safe to Proceed” and central IRB approvals for the Phase 2 Ropidoxuridine trial; first patient/dose was expected in Q2 2024, positioning clinical-readout catalysts ahead .
  • Financials reflected no revenue, reduced R&D as manufacturing completed ahead of trial start, and a net loss of $(1.73)M with EPS of $(0.10); working capital was $2.92M and cash plus marketable securities totaled ~$4.19M at quarter-end .
  • Shuttle Diagnostics was formed to develop predictive diagnostics (PC‑RAD and PSMA‑B), adding a potential non-therapeutic revenue pathway alongside HDAC6 inhibitor development .
  • Estimate comparisons were unavailable; S&P Global consensus for Q1 2024 EPS and revenue could not be retrieved, and no earnings call transcript was found for Q1 2024, limiting Street beat/miss analysis and Q&A insights [ListDocuments result] [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • FDA “Safe to Proceed” and central IRB approval received; site enrollment being finalized across up to six institutions, with first patient/dose targeted for Q2 2024, de‑risking clinical initiation logistics .
  • Strategic expansion into diagnostics via Shuttle Diagnostics and Georgetown IP licenses (predictive biomarker test for prostate RT outcomes and PSMA‑B theranostic), potentially diversifying future revenue streams and enhancing RT personalization .
  • Manufacturing of Ropidoxuridine API and drug product completed and shipped to CRO for distribution, supporting trial readiness; management reaffirmed clinical protocol alignment with FDA guidance .

What Went Wrong

  • No revenue and continued losses; Q1 2024 net loss was $(1.73)M, EPS $(0.10), reflecting the pre-commercial stage and financing costs tied to the 2023 convertible note .
  • Substantial doubt about going concern, with need for additional capital to fund trial expansion and operations; management initiated a planned $4.5M rights offering and SBIR applications, underscoring financing dependency .
  • Internal controls remained ineffective (material weaknesses in accounting policy documentation, segregation of duties, R&D classification, and ITGCs), increasing reporting risk while the company scales activities .

Financial Results

Note: No Q4 2023 quarterly financials were available; comparisons include prior year (Q1 2023) and the recent prior quarter with available data (Q3 2023).

MetricQ1 2023Q3 2023Q1 2024
Revenue ($USD)$0 $0 $0
Total Operating Expenses ($USD)$1,544,780 $1,599,146 $1,384,847
Net Loss ($USD)$(975,097) $(1,792,754) $(1,731,031)
Diluted EPS ($USD)$(0.07) $(0.11) $(0.10)
R&D Expense ($USD)$921,801 $1,140,307 $586,104
G&A Expense ($USD)$255,355 $170,423 $324,609
Legal & Professional ($USD)$367,624 $288,416 $474,134
Interest Expense ($USD)$599,331 $623,465 $497,515
Balance Sheet & LiquidityQ1 2023Q3 2023Q1 2024
Cash & Cash Equivalents ($USD)$7,169,268 $3,885,997 $1,398,628
Marketable Securities ($USD)$0 $2,920,592 $2,789,251
Working Capital ($USD)$7,602,675 $6,185,171 $2,921,802
Convertible Note Principal Outstanding ($USD)—$2,589,300 $2,019,656

Operational drivers in Q1 2024: R&D down 36% YoY due to completion of drug production and waiting for trial initiation; G&A up 27% driven by RSU grants; legal/professional up 29% tied to filings/contracts/financing . Other income/expense reflected $0.2M gain in derivative fair value and $0.5M interest on the convertible note .

No segment reporting or KPIs beyond clinical and diagnostic milestones; company does not have revenue-generating segments .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 2 Ropidoxuridine trial start (glioblastoma)Q2 2024Preparing IND/CMC; PIND feedback (Q3 2023) FDA “Safe to Proceed,” central IRB approved; “first patient, first dose” expected Q2 2024 Raised (specific timing set)
Diagnostics (PC‑RAD predictive test; PSMA‑B theranostic)2024Program formation/licensing underway (Q3 2023) Shuttle Diagnostics formed; Georgetown and PSMA‑B IP licenses executed Advanced (organizational and IP progress)
Financing plan2024Convertible note (Jan 2023); cash/marketable securities (Q3 2023) Intent to pursue $4.5M rights offering; SRO LLC $2.25M commitment/backstop and escrow framework New (capital plan disclosed)

No revenue/EPS/OpEx margin guidance ranges were provided; the company focuses on operational milestones, regulatory steps, and financing progress .

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was found. Themes below reflect press releases and MD&A narrative.

TopicPrevious Mentions (Q3 2023 and Q4 2023)Current Period (Q1 2024)Trend
Clinical initiation (Ropidoxuridine)PIND feedback; IND preparation; trial on track for late 2023/early 2024 FDA “Safe to Proceed,” central IRB approval; first patient/dose expected Q2 2024 Progressing to execution
Manufacturing & supplyAPI and capsules completed for trial; CRO distribution ready Drug product shipped to CRO; site agreements being finalized Operational readiness maintained
Diagnostics strategyBiomarker licensing; CLIA lab planning; market rationale Shuttle Diagnostics formed; PC‑RAD/PSMA‑B IP secured Formalized and expanded
Financing & capital structureConvertible note and warrants; strong working capital Q3 2023 Rights offering intent and SRO LLC commitment; going concern risk flagged Heightened financing focus
Controls & reportingIdentified material weaknesses; improvements underway Controls still ineffective; broader weaknesses cited Ongoing remediation

Management Commentary

  • “We received the ‘Safe to Proceed’ letter from the FDA to commence our Phase 2 clinical trial of Ropidoxuridine… We expect to have ‘first patient, first dose’ in the second quarter of 2024.” — CEO Anatoly Dritschilo, M.D. .
  • “We aim to develop pretreatment diagnostic blood tests for prostate cancer patients… PC‑RAD test… and PSMA‑B ligand… theranostic molecule… We intend to develop Shuttle Diagnostics to offer prognosis and guide treatment decisions.” — CEO .
  • “With FDA recommended changes incorporated into the revised protocol, the Company believes it remains on track to commence its Phase II clinical study in the second quarter of 2024.” — MD&A .
  • “We achieved a significant milestone in January 2024 with the receipt of the ‘Safe to Proceed’ letter… finalizing site enrollment… first patient, first dose expected in Q2 2024.” — CEO (Q4 2023 update) .

Q&A Highlights

No Q1 2024 earnings call transcript was available; thus, Q&A themes, clarifications, and tone assessments cannot be provided from a call source [ListDocuments result].

Estimates Context

  • Wall Street consensus estimates for Q1 2024 EPS and revenue via S&P Global were unavailable at the time of retrieval; as a development-stage company with no revenue, Street coverage may be limited [GetEstimates error].
  • Given the absence of consensus, estimate-based beat/miss analysis cannot be performed; future coverage may increase upon Phase 2 trial enrollment updates and diagnostic progress [GetEstimates error].

Key Takeaways for Investors

  • Near-term catalyst: first patient/dose in the Phase 2 glioblastoma trial in Q2 2024; subsequent enrollment pace and initial safety/operational updates could drive stock reaction .
  • Strategic optionality: Shuttle Diagnostics and Georgetown/PSMA‑B IP create potential non-therapeutic monetization pathways that may diversify future revenue and reduce binary drug-risk exposure .
  • Financing overhang: going concern risk and reliance on a $4.5M rights offering (with SRO LLC commitment/backstop) introduce execution risk; monitor escrow progress and final terms .
  • Cost dynamics: R&D down as manufacturing completed; expect re‑acceleration as trial operations scale; legal/professional expenses likely remain elevated due to filings/contracts/financing .
  • Capital structure and cash runway: cash of $1.40M and marketable securities of $2.79M at Q1 2024; convertible note principal reduced to ~$2.02M outstanding; runway sensitive to rights offering closure and cash burn .
  • Controls risk: persistent material weaknesses in internal controls and ITGCs represent reporting risk; remediation progress should be tracked to reduce potential volatility around filings .
  • Trading lens: headlines around trial start/first patient, diagnostic milestones, and financing closings likely act as primary catalysts; lack of Street estimates/call Q&A suggests price moves may be event-driven and liquidity sensitive [ListDocuments result].