Executive Summary

Q3 2024 was operationally significant: all six Phase 2 glioblastoma trial sites were finalized and the first three patients were dosed in October, marking first clinical dosing for Ropidoxuridine; management reiterated a 18–24 month trial timeline .
Financially, SHPH reported no revenue and a larger net loss versus prior year and prior quarter as legal/professional expenses surged with reaudits and financing-related work; cash at quarter-end was $0.16M, improving to $4.1M by Oct 31 following an equity raise and bridge notes .
Balance sheet actions included paying off the outstanding balance of the January 2023 senior secured convertible note and completing a $4.5M public offering with warrants, plus $0.79M of convertible bridge notes (CEO participated) .
Listing/compliance: SHPH regained Nasdaq timeliness compliance in Q2, but received a September notice for stockholders’ equity deficiency; a remediation plan was submitted in October .
Wall Street consensus (S&P Global) was unavailable this quarter; estimate beat/miss comparisons are not provided.

What Went Well and What Went Wrong

What Went Well
- “Successfully dosed first three patients in the Phase 2 clinical trial of Ropidoxuridine” and finalized agreements with all six planned sites, accelerating clinical execution .
- Financing and balance sheet progress: “Paid off the entirety of the outstanding balance” on the Jan-2023 senior secured convertible note; completed a $4.5M public offering and raised $0.79M via senior secured convertible bridge notes (CEO invested $237.5K) .
- CEO tone: “The initiation of the Phase 2 trial is a significant milestone… as we look to leverage radiation sensitizers to increase cancer cure rates” .
What Went Wrong
- Operating costs rose sharply YoY in Q3: legal/professional expenses increased by 358% to $1.32M, driving total opex to $3.05M and net loss to $3.78M .
- Liquidity tight at quarter-end (cash $0.16M; working capital deficit $1.30M), and management disclosed substantial doubt about going concern pending additional financing .
- Ongoing internal control material weaknesses and Nasdaq stockholders’ equity deficiency notice heighten execution/listing risk despite remedial steps .

Financial Results

Metric	Q3 2023	Q2 2024	Q3 2024
Revenue ($USD)	$0	$0	$0
Net Loss ($USD)	$(1,792,754)	$(2,031,215)	$(3,784,082)
Diluted EPS ($USD)	$(0.91)	$(0.96)	$(1.59)
Total Operating Expenses ($USD)	$1,599,146	$1,482,634	$3,051,561
Research & Development ($USD)	$1,045,177	$645,719	$1,400,564
General & Administrative ($USD)	$265,553	$310,038	$328,995
Legal & Professional ($USD)	$288,416	$526,877	$1,322,002
Loss from Operations ($USD)	$(1,599,146)	$(1,482,634)	$(3,051,561)

Segment breakdown: Not applicable (development-stage, no revenue segments).

KPIs:

KPI	Q1 2024	Q2 2024	Q3 2024
Central IRB approval obtained	Yes	Yes	Yes
Trial sites engaged	Up to six planned	Two sites ready; all six anticipated in coming months	All six finalized
First patient dosed	Expected in Q2 2024	Not disclosed	First three patients dosed in Oct
Trial timeline	Not disclosed	Expected completion in 18–24 months	Expected completion in 18–24 months

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Phase 2 trial start/dosing	2024	“First patient, first dose” expected Q2 2024	First three patients dosed in Oct (Q4) 2024	Lowered/Delayed (timing slip)
Trial completion timeline	2024–2026	18–24 months	18–24 months reaffirmed	Maintained
Trial site activation	2024	Two sites ready, six anticipated soon	Six sites finalized	Raised (execution achieved)
Liquidity outlook	Next 12 months	Working capital ~$1.1M at Q2; pursuing financing	Cash $0.16M and working capital deficit at Q3; completed $4.5M offering and $0.79M bridge notes; cash $4.1M at Oct 31	Mixed: near-term deficit improved post-raise

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1, Q2)	Current Period (Q3)	Trend
R&D execution (Ropidoxuridine)	FDA “Safe to Proceed”; central IRB approval; six institutions planned; “first patient, first dose” targeted Q2	Six sites finalized; first three patients dosed; dosing groups 1,200 mg/day vs 960 mg/day; 18–24 month timeline	Positive execution; dosing initiated
Regulatory/legal/controls	Reaudit/timeliness regained; internal control weaknesses continue	Material weaknesses persist; legal/professional costs surge; Nasdaq equity deficiency notice; plan submitted	Mixed: remediation underway but risks elevated
Financing/liquidity	Rights offering planning; CRO work order; engaged AGP	$4.5M offering; $0.79M bridge notes; CEO invested; cash $4.1M on Oct 31	Improved liquidity post-raise
Listing/compliance	Regained Listing Rule 5250(c) timeliness	Received 5550(b)(1) stockholders’ equity notice; submitted plan	Ongoing compliance risk

Management Commentary

“We made tremendous progress…with the first three patients dosed in October 2024,” highlighting engagement of six nationally recognized centers likely to treat the target glioblastoma cohort and framing initiation as “a significant milestone” .
“The initiation of patient dosing…is a significant milestone… as we look to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life” .
On financing and balance sheet: the company “paid off the entirety of the outstanding balance” of the 2023 senior secured convertible note and completed a $4.5M offering to fund IND-enabling and Phase 1/2 trials and working capital .

Q&A Highlights

No public earnings call transcript was furnished; analysis draws from the Q3 10-Q and corporate press releases .

Estimates Context

Wall Street consensus (S&P Global) for Q3 2024 was unavailable; therefore, estimate comparisons (EPS/revenue beats/misses) are not provided this quarter.

Key Takeaways for Investors

Clinical inflection: first dosing in Phase 2 glioblastoma trial and full site activation are tangible de-risking steps; monitor enrollment cadence and any interim survival/safety updates over the next 18–24 months .
OpEx normalization needed: legal/professional expenses spiked to $1.32M driving net loss; if reaudits and financing work ebb, losses could moderate; track quarterly opex trends .
Liquidity improved post-raise, but runway still constrained by trial costs; watch additional financings and potential non-dilutive funding (e.g., NIH SBIR) to mitigate going concern risk .
Balance sheet cleanup and warrant/derivative remeasurement reduced derivative liabilities; continued simplification lowers future non-cash volatility .
Listing risk remains: equity deficiency notice requires execution on the Nasdaq remediation plan; slippage could be a stock overhang .
Near-term trading implications: catalysts include additional patient dosing/enrollment updates, site activation progress, and financing developments; any delays or unexpected safety signals would be negative, while timely enrollment and clear regulatory communication would be positive .

References: Q3 2024 8-K corporate update and Exhibit 99.1 ; Q3 2024 10-Q ; Oct 28 site enrollment press release ; Oct 29 dosing press release ; Nov 1 offering documents ; Q2 2024 corporate update and 10-Q ; Nasdaq notices and compliance updates .

Shuttle Pharmaceuticals Holdings, Inc. (SHPH)·Q3 2024 Earnings Summary