Executive Summary

Q4 2024 was steady operationally with minimal revenue ($0.02M) and controlled OpEx; net loss was $(3.63)M, or $(0.55) per share, modestly wider sequentially vs Q3 but improved year over year on a per-share basis given share count changes .
The key post-quarter catalyst: FDA lifted the clinical hold on cadisegliatin; vTv plans to resume the CATT1 Phase 3 trial in Q2 2025 and shorten the trial duration from 12 to 6 months to accelerate topline data timing, a clear de-risking and timeline acceleration for the T1D program .
Cash and equivalents rose to $36.7M at 12/31/24 (vs $9.4M at 12/31/23), primarily from the February 2024 private placement and additional ATM proceeds, supporting near-term execution through the trial restart .
Commercial readiness advanced with the appointment of a Chief Commercial Officer, adding diabetes commercial leadership as the program approaches registrational execution .
Street consensus (S&P Global) for Q4 2024 EPS/revenue was not available; no company guidance on revenue/EPS was provided, leaving the story driven by clinical/regulatory milestones rather than near-term P&L beats/misses (consensus unavailable).

What Went Well and What Went Wrong

What Went Well

FDA lifted the cadisegliatin clinical hold; the company plans a protocol amendment to shorten CATT1 from 12 to 6 months, accelerating topline data and initiation of larger pivotal studies: “This amendment accelerates the time to topline data...” (CEO) .
Strengthened go-to-market bench: vTv appointed a Chief Commercial Officer with >25 years of diabetes-related commercial experience, signaling preparation for registrational progress .
Balance sheet improvement: year-end cash of $36.7M vs $9.4M prior year, driven by capital raising, supporting clinical resumption and operations .

What Went Wrong

Revenue remains de minimis; Q4 revenue was $0.02M, highlighting limited near-term commercial contributions as the story remains clinical .
Operating loss persists; Q4 net loss attributable to vTv was $(3.63)M and EPS $(0.55), reflecting the development-stage profile .
No earnings call transcript or formal guidance; limited public Q&A and no quantitative operating guidance can leave uncertainty around cash runway specifics and operating cadence (no earnings-call-transcript located in the document set; Q4 press release/8-K contain no guidance) .

Financial Results

Financial snapshot (P&L) – quarterly comparison (oldest → newest):

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	$0.00	$0.00	$0.00	$0.02
Research & Development ($USD Millions)	$2.14	$3.44	$3.22	$2.23
General & Administrative ($USD Millions)	$2.57	$3.72	$3.28	$2.68
Interest Income ($USD Millions)	$0.09	$0.55	$0.50	$0.43
Net Loss attrib. to vTv ($USD Millions)	$(3.48)	$(5.18)	$(4.78)	$(3.63)
EPS (basic & diluted)	$(1.67)	$(0.81)	$(0.88)	$(0.55)
Weighted Avg Shares (Basic & Diluted)	2,084,973	6,403,444	5,456,307	6,582,844

Balance sheet KPIs (quarter-end):

Metric	Dec 31, 2023	Jun 30, 2024	Sep 30, 2024	Dec 31, 2024
Cash & Equivalents ($USD Millions)	$9.45	$45.53	$41.57	$36.75
Accounts Payable & Accrued Exp. ($USD Millions)	$10.24	$6.79	$6.23	$5.03
Total Liabilities ($USD Millions)	$29.57	$26.02	$25.25	$23.97
Total Stockholders’ Equity ($USD Millions)	$(24.68)	$20.44	$17.91	$14.30

Notes:

No segment reporting or non-GAAP reconciliation was provided in the Q4 materials; results are GAAP and reflect a development-stage profile .
No Street consensus was available to present “vs estimates”; company also provided no quantitative financial guidance (see Estimates Context).

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
CATT1 Phase 3 – cadisegliatin (T1D)	Program timing	Working with FDA to resolve clinical hold; discussions ongoing (Q3 update)	FDA clinical hold lifted (Mar 14, 2025). CATT1 expected to resume in Q2 2025, with protocol shortened from 12 to 6 months; original 6-month hypoglycemia endpoints unchanged	Raised visibility/accelerated timeline
Protocol design	Trial duration	12 months in original design	6 months after planned protocol amendment; removes additional 6-month safety collection with no impact to key endpoints	Shortened/accelerated
Commercial readiness	Org. capability	Standard G&A	Appointed Chief Commercial Officer to prepare for registrational progress	Strengthened leadership
Financial guidance	FY/Qtr	None disclosed	None disclosed	Maintained (no guidance)

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available; themes below reflect company press releases and 8-K disclosures.

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2024)	Trend
Regulatory/Clinical Hold	FDA clinical hold in July 2024; company working to resolve; no CATT1 dosing at time of hold	FDA lifted clinical hold March 14, 2025; plan to resume CATT1 in Q2 2025	Positive resolution/de-risking
R&D Execution (CATT1)	First patient screened before hold; preparing registrational package	Protocol amendment to shorten trial from 12 to 6 months to accelerate topline data	Accelerated data timing
Partnerships	Expanded HPP737 Newsoara license to global upon $20M upfront payment (pending)	No new Q4-specific deal economics disclosed in Q4 PR; continued focus on cadisegliatin	Neutral; watch for monetization
Oncology partnered asset (Azeliragon)	Orphan Drug in pancreatic cancer (May 2024)	Additional Orphan Drug designation (brain metastasis from breast cancer) announced by partner in Dec 2024	Incremental optionality via partner
Commercial Readiness	N/A	Added CCO with diabetes experience	Building go-to-market bench
Liquidity	Cash $45.5M (Q2), $41.6M (Q3)	Cash $36.7M (Q4)	Drawdown as expected with OpEx

Management Commentary

“We expect to resume our Phase 3 CATT1 trial in patients with T1D in the second quarter of 2025 following submission of a protocol amendment shortening the trial duration from 12 to 6 months.” – Paul Sekhri, Chairman, President & CEO .
“Importantly, this amendment accelerates the time to topline data and allows initiation of our required pivotal studies sooner… with no impact on the original key endpoints of the study.” – Paul Sekhri .
“We are pleased to have strengthened our commercial leadership with the appointment of Martin Lafontaine as our Chief Commercial Officer…[with] commercial experience in diabetes which will position us for success as we prepare to further progress across our registrational program for cadisegliatin.” – Paul Sekhri .

Q&A Highlights

No Q4 2024 earnings call transcript or Q&A session was available in the document set; no additional clarifications beyond the press release and 8-K were provided .

Estimates Context

Wall Street consensus EPS and revenue for Q4 2024 (S&P Global) were not available; vTv did not provide financial guidance in the quarter. As a development-stage biotech, the stock narrative is driven by clinical/regulatory catalysts (clinical hold resolution; CATT1 restart/acceleration) rather than quarterly beats/misses .
Where “vs. estimates” would ordinarily appear, values are marked N/A due to lack of S&P Global consensus coverage for this quarter.

Key Takeaways for Investors

De-risking and acceleration: FDA’s hold lift and the 6-month protocol materially shorten time to topline data for cadisegliatin CATT1, a clear positive for near-term catalysts in Q2 2025–H1 2026 timelines .
Balance sheet supports execution: $36.7M cash at year-end 2024 provides funding to reinitiate CATT1; watch quarterly cash burn as the program restarts .
Operational discipline: Q4 OpEx moderated vs earlier 2024 (R&D and G&A down sequentially from Q3), while interest income contributes modestly to narrowing losses .
Commercial build-out: Hiring a CCO with diabetes experience signals preparatory steps for potential registrational progress and eventual commercial planning .
Partnership optionality: Expanded HPP737 global license (pending upfront receipt) and partner-driven orphan designations for azeliragon create possible non-dilutive optionality, albeit with uncertain timing for cash flows .
No Street anchors: Absence of consensus estimates and guidance keeps focus on binary clinical milestones; stock is likely to trade on trial restart progress, protocol amendment acceptance, and cadence of patient enrollment/data readouts .
Monitor next steps: Key watch items are protocol amendment acceptance, CATT1 relaunch in Q2 2025, enrollment velocity, and clarity on broader Phase 3 program design to support an eventual NDA .

Appendix: Additional Q4 Context Press Releases

Evercore HealthCONx participation (Dec 2, 2024) – investor engagement update .
Partner Cantex received additional FDA Orphan Drug Designation for azeliragon (Dec 9, 2024), expanding oncology program optionality .

Data Sources

Q4 2024 earnings 8-K and Exhibit 99.1 press release, including financial statements and commentary .
Q4 2024 press release (duplicative content set; used for cross-reference) -.
Q3 2024 earnings 8-K and press release - -.
Q2 2024 earnings 8-K and press release - -.
FDA clinical hold lifted press release (Mar 17, 2025) .

vTv Therapeutics Inc. (VTVT)·Q4 2024 Earnings Summary