Executive Summary

Q2 2025 was a transition quarter: Vivani reported no revenue, a larger net loss from continued R&D investment, and a strategic pivot to prioritize semaglutide implant NPM-139 after positive LIBERATE-1 safety/tolerability data and encouraging NPM-139 preclinical weight-loss results .
Liquidity extended: a $10.0M staged private equity financing (at $1.26/share) strengthened the balance sheet and extended the cash runway “into the second half of 2026,” up from “mid‑2026” previously .
Pipeline catalysts: management now expects to initiate NPM-139 clinical development in 2026; a more detailed program update is planned later in 2025 .
Corporate action: Vivani targets completion of the Cortigent spin-off in Q3–Q4 2025, creating two focused public companies (Biopharma and Neurostimulation) .

What Went Well and What Went Wrong

What Went Well
- Strategic prioritization of NPM-139 following data: “LIBERATE‑1…achieved its primary objectives…we prioritize advancement of NPM‑139, with clinical development expected to begin in 2026” .
- Incremental financing on attractive terms (no warrants/fees) to extend runway: $10.0M private placement at market price; “no placement agent or investment banking fees” .
- Clear spin-off timeline for Cortigent and operational focus: “anticipates completing the spin-off…in the third quarter or fourth quarter of 2025” .
What Went Wrong
- Operating loss widened as R&D scaled: Q2 net loss −$7.1M vs −$5.4M YoY; higher R&D (+35% YoY) and G&A (+25% YoY) from Biopharma drove the increase .
- Continued pre-revenue profile and cash burn: no product revenue, six-month operating cash outflow of −$11.25M in 1H25 .
- Execution risk and timelines: while LIBERATE‑1 met safety/tolerability goals, NPM‑139 still requires PK optimization and IND clearance; the first human study is guided to 2026, implying longer time to value inflection .

Financial Results

Headline P&L and EPS

Metric	Q4 2024	Q1 2025	Q2 2025
Revenue ($)	$0 (no product revenue)	$0 (no product revenue)	$0 (no product revenue)
Net Loss ($M)	−$6.05	−$6.30	−$7.14
Diluted EPS ($)	−$0.11	−$0.11	−$0.12
R&D Expense ($M)	$4.30	$4.22	$4.76
G&A Expense ($M)	$2.16	$2.34	$2.70
Other Income, net ($M)	$0.41	$0.26	$0.32

Notes: Management attributes Q2 increases in R&D (+35% YoY) and G&A (+25% YoY) mainly to Biopharma division activity .

Balance Sheet and Liquidity

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash, cash equivalents and restricted cash ($M)	$19.69	$14.30	$8.13
Cash & cash equivalents only ($M)	$18.35	$13.01	$6.79
Total Assets ($M)	$41.56	$35.45	$28.90
Total Liabilities ($M)	$23.95	$23.83	$23.99
Stockholders’ Equity ($M)	$17.61	$11.62	$4.91

Cash flow: Net cash used in operating activities −$11.25M in 1H25 (vs −$9.31M in 1H24) .

Segment View (Q2 2025)

Segment (Q2 2025)	Operating Expenses ($M)	Other Income (Expense), net ($M)	Segment Net Loss ($M)
Biopharma	6.73	−0.36	−6.37
Neuromodulation	0.70	0.04	−0.78
Total	7.46	0.32	−7.14

KPIs and Operating Highlights

KPI	Q4 2024	Q1 2025	Q2 2025
Weighted Avg Shares (Basic/Diluted, M)	57.42	59.24	59.24
Cash Runway (management view)	“into Q2’26” (post $8.25M)	“into mid‑2026” (post $3M & $8.25M)	“into 2H’26” (post $10M)
Program Milestones	LIBERATE-1 progressing; top-line 2025	LIBERATE‑1 fully enrolled; top‑line mid‑2025	LIBERATE‑1 achieved primary objectives; NPM‑139 prioritized

Guidance Changes

Metric/Topic	Period	Previous Guidance	Current Guidance	Change
Cash runway	Through 2026	Into mid‑2026 (Q1 update)	Into 2H 2026 (Q2 update)	Raised/extended
NPM‑139 clinical start	First‑in‑human	Not specified (pre‑Q2)	“Clinical development expected to begin in 2026”	New specific timing
NPM‑139 program update	2025	Not specified	“More detailed program update later this year”	New milestone
Cortigent spin‑off	2025	Spin‑off intent filed Form 10 (May 29)	“Anticipates completing… in Q3 or Q4 2025”	Timeline clarified
LIBERATE‑1 status	2025	Top‑line mid‑2025	Primary objectives achieved; supports platform	Milestone realized

No quantitative guidance was provided for revenue, margins, OpEx, OI&E, or tax rate .

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was filed; themes reflect company press releases/10‑Q disclosures.

Topic	Q4 2024 (Q‑2)	Q1 2025 (Q‑1)	Q2 2025 (Current)	Trend
Pipeline focus & differentiation	Emphasis on GLP‑1 implants for adherence/tolerability; NPM‑115/NPM‑139 highlighted	LIBERATE‑1 fully enrolled; positive preclinical NPM‑139 data; plan to advance both	Prioritize NPM‑139; LIBERATE‑1 met primary objectives; 2026 clinical start guide	Pivot to semaglutide implant
Financing & runway	$19.7M cash; ops into 2H’25	$8.25M raise; runway into Q2’26; +$3M (May)	$10M staged private placement; runway into 2H’26	Runway extended
Regulatory/clinical	NPM‑119 IND cleared; LIBERATE‑1 Australia plan	LIBERATE‑1 on track mid‑2025; first human implant done	LIBERATE‑1 achieved primary objectives; supports platform	Platform de‑risking
Corporate actions	Focus on biopharma; neurostimulation options	Announced Cortigent spin‑off plan	Spin‑off anticipated Q3–Q4’25	Separation clarified
Leadership	—	New CFO named (effective June 15)	CFO transition completed	Finance bench strengthened
Legal/macro	Pixium matter accrual; ongoing	Litigation updates; risk disclosures	Ongoing litigation; tariff/macro risks noted	Stable risk set

Management Commentary

“We are very pleased to report that LIBERATE‑1…achieved its primary objectives… it is an easy decision to focus our resources and prioritize efforts to accelerate NPM‑139 into clinical‑stage development.” — CEO Adam Mendelsohn, Ph.D. .
“New $10M equity financing to enable accelerated development of NPM‑139 while securing financial position into the second half of 2026.” — Company release .
“We anticipate initiating the NPM‑139 clinical program in 2026.” — CEO Adam Mendelsohn, Ph.D. .
“Vivani…anticipates completing the spin‑off of Cortigent…as an independent publicly traded company in the third quarter or fourth quarter of 2025.” — Company release .

Q&A Highlights

No Q2 2025 earnings call transcript was filed or available in company documents; no Q&A to summarize (search returned no “earnings‑call‑transcript” for Aug–Sep 2025) [ListDocuments 0 results].

Estimates Context

Wall Street consensus (S&P Global) for Q2 2025 EPS and revenue was unavailable; there were no estimate records returned for Q4 2024, Q1 2025, or Q2 2025 (Primary EPS/Revenue consensus and # of estimates all blank). Values retrieved from S&P Global. [GetEstimates: empty data]

Given limited/absent sell‑side coverage, we benchmark results on absolute P&L and cash trends versus prior periods.

Key Takeaways for Investors

Financing de‑risked near‑term liquidity: staged $10M at‑market private placement extended runway into 2H’26, supporting clinical start of NPM‑139 and ongoing platform development .
Strategic pivot to semaglutide (NPM‑139) concentrates resources on the largest GLP‑1 market with strong human efficacy precedent; 2026 first‑in‑human target is the next major catalyst .
Platform de‑risking: LIBERATE‑1 met primary safety/tolerability objectives and showed encouraging performance signals, supporting long‑acting, steady‑release implant viability across molecules .
Spin‑off catalyst: Cortigent separation expected Q3–Q4 2025 could sharpen focus on biopharma and potentially unlock value/optionality for neurostimulation assets .
Watch burn and OpEx scaling: 1H25 operating cash outflow of −$11.25M reflects R&D acceleration; monitor biopharma R&D cadence and milestone timing against cash runway .
Execution risks: IND enablement, PK optimization, and regulatory clearances remain gating steps for NPM‑139; timelines to first human dosing (2026) imply a multi‑year path to pivotal data .
Legal backdrop manageable but ongoing (Pixium, Oppenheimer); no change to thesis but keep on risk register .

Appendix: Source Details

Q2 2025 8‑K (Results and $10M financing; EX‑99.1) .
Q2 2025 10‑Q (financials, segments, liquidity, risks) .
Aug 5, 2025 press release on NPM‑139 advancement and LIBERATE‑1 results .
Q1 2025 8‑K (results; $3M financing; LIBERATE‑1 status) .
FY/Q4 2024 8‑K (baseline financials; business update) .

Vivani Medical, Inc. (VANI)·Q2 2025 Earnings Summary