Executive Summary

Q1 2025 was a pre-revenue quarter with net loss of $5.1m and EPS of $(0.77), while the company reinitiated screening in its Phase 3 CATT1 trial after the FDA lifted the clinical hold in March; topline data are expected in 2H 2026 .
EPS modestly beat a small-sample Wall Street consensus of $(0.815); revenue was in line at $0; consensus was based on 2 EPS and 1 revenue estimate .
Cash was $31.1m at 3/31/25 vs $36.7m at 12/31/24, reflecting operating spend as the program restarts .
Key catalysts: continued CATT1 enrollment/screening updates and execution under the shortened 6‑month protocol (CGM added), with topline in 2H 2026; management highlighted the program’s first‑in‑class potential in T1D .

What Went Well and What Went Wrong

What Went Well
- FDA clinical hold was lifted in March; CATT1 Phase 3 screening reinitiated in May under an amended protocol that shortens duration to 6 months and adds CGM, accelerating time to topline data while preserving key endpoints .
- Management emphasized momentum: “Our late stage cadisegliatin program is advancing with potential to be the first oral adjunct therapy for T1D” .
- G&A decreased YoY in Q1 to $3.7m from $4.0m, reflecting lower payroll, legal and other operating costs (partially offset by higher share‑based expense) .
What Went Wrong
- Revenue fell to $0 in Q1 vs $1.0m in the prior-year period, eliminating a small offset to operating costs .
- Net loss widened YoY to $(5.092)m from $(4.865)m, driven by operating loss with only modest interest income ($0.331m) .
- Cash declined to $31.1m from $36.7m sequentially as spend resumed; topline remains a 2H 2026 event, keeping value realization on a longer horizon .

P&L summary (in $USD thousands, except per share); periods ordered oldest → newest:

Metric	Q1 2024	Q4 2024	Q1 2025
Revenue	1,000	17	0
Research & Development	2,649	2,234	2,830
General & Administrative	3,978	2,675	3,673
Total Operating Expenses	6,627	4,909	6,503
Operating Loss	(5,627)	(4,892)	(6,503)
Interest Income	79	429	331
Other (Income)/Expense, net	(371)	26	(45)
Net Loss attributable to vTv	(4,865)	(3,634)	(5,092)
EPS (basic & diluted)	(1.17)	(0.55)	(0.77)
Weighted Avg. Shares	4,141,492	6,582,844	6,582,844

Actual vs Consensus (Q1 2025):

Values retrieved from S&P Global.*

Balance sheet/KPIs:

KPI	Q3 2024	Q4 2024	Q1 2025
Cash & Equivalents ($USD Thousands)	41,571	36,746	31,059
Accounts Payable & Accrued Expenses ($USD Thousands)	6,226	5,027	4,191
Total Assets ($USD Thousands)	43,164	38,266	32,027

No reportable segments; no gross margin given due to no product revenue .

Metric	Period	Previous Guidance	Current Guidance	Change
CATT1 topline timing (cadisegliatin)	Program milestone	Not explicitly dated in prior update; company planned protocol amendment to shorten study	2H 2026 topline expected	Provided timing (clarified)
CATT1 status	Near term	Resume trial in Q2 2025 following hold lift	Screening reinitiated (May 2025) under amended protocol	Achieved/resumed
CATT1 trial duration	Trial design	Plan to reduce 12 → 6 months	6 months (amendment submitted/implemented)	Implemented
CATT1 instrumentation	Trial ops	Not specified	CGM provided to all participants	Added
Financial guidance	FY/Qtr	None provided	None provided	Unchanged

No earnings call transcript was found for Q1 2025; analysis reflects company press releases and 8‑K. [ListDocuments showed 0 transcripts in period]

Topic	Previous Mentions (Q-2: Q3 2024; Q-1: Q4 2024)	Current Period (Q1 2025)	Trend
Regulatory/legal (FDA)	Q3’24: FDA clinical hold announced; working to address basis	Hold lifted (Mar 14, 2025); trial resuming	Improving; risk reduced
R&D execution	Q3’24: Addressing hold; no dosing in CATT1 at hold	Screening reinitiated; protocol shortened; CGM added	Re-acceleration
Program timelines	Q3/Q4’24: Intent to shorten to 6 months; resume Q2 2025	Topline 2H 2026 articulated	Greater clarity
Commercial readiness	Q4’24: CCO appointed to prepare for late-stage program	No additional commercial updates in Q1 PR	Building capabilities
Financial discipline	Q3’24: Elevated G&A vs 2023	Q1’25 G&A down YoY; R&D slightly up YoY	Mixed: leaner G&A, steady R&D

“Our late stage cadisegliatin program is advancing with potential to be the first oral adjunct therapy for T1D. We reinitiated screening in our Phase 3 CATT1 study and… expect topline Phase 3 data… in the second half of 2026.” — Paul Sekhri, Chairman, President & CEO
“We are thrilled that we have resumed our CATT1 Phase 3 trial and screened a subject under the amended protocol… We look forward to reporting topline Phase 3 data from CATT1 in the second half of 2026.” — Paul Sekhri
“We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program… we plan to submit a protocol amendment to reduce the time to topline data by 6‑months.” — Paul Sekhri

No Q1 2025 earnings call transcript was available; no Q&A disclosures to report. [ListDocuments found 0 transcripts for 2025-01-01 to 2025-06-30]

Q1 2025 EPS of $(0.77) vs S&P Global consensus of $(0.815)* was a small beat; revenue of $0 matched consensus $0* (limited coverage: 2 EPS, 1 revenue estimate) .
Given minimal revenue and early-stage profile, estimate dispersion is likely to remain driven by opex pacing and trial timelines rather than near-term sales; no formal financial guidance provided that would reset consensus .

Values retrieved from S&P Global.*

Regulatory overhang has cleared: FDA lifted the hold; CATT1 screening reinitiated under a shortened 6‑month protocol, improving execution visibility and accelerating topline to 2H 2026 .
Q1 results were in line with an R&D-stage profile (no revenue, negative EPS) with a modest EPS beat vs a thin consensus base; operating discipline showed in YoY G&A reduction .
Cash declined to $31.1m from $36.7m sequentially; monitoring burn versus enrollment cadence will be key as activities ramp .
Near-term catalysts are operational: enrollment/screening updates, protocol-driven efficiency, and potential additional program updates; topline remains a 2H 2026 event .
Investment case hinges on cadisegliatin’s first‑in‑class adjunct potential in T1D (hypoglycemia event reduction as the primary endpoint) and successful Phase 3 execution .
With no financial guidance and limited sell-side coverage, quarterly P&L variances are less stock‑moving than clear progress on clinical milestones; updates on enrollment pace and trial site activity could drive sentiment .
Maintain focus on capital needs versus timeline to pivotal data and any business development that could extend runway ahead of topline .

References:

Q1 2025 press release and 8‑K (financials and program update) .
CATT1 screening reinitiation press release .
FDA hold lifted press release .
Q4 2024/FY 2024 press release (sequential comparisons, cash, and operating details) .
Q3 2024 press release (trend context) .
Consensus estimates from S&P Global via tool (EPS and revenue) — see asterisk notation above.*