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Vivani Medical, Inc. (VANI)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 focused on clinical execution and financing: Vivani completed LIBERATE-1 (first clinical application of NanoPortal) and reiterated plans to initiate Phase 1 for NPM-139 (semaglutide implant) for chronic weight management in H1 2026, with parallel investments to enable rapid Phase 2 dose-ranging pending Phase 1 and regulatory feedback .
  • Operating loss modestly widened year over year; net loss was $6.5M (vs. $6.0M YoY), and EPS was $(0.11) (flat YoY), reflecting increased R&D and G&A as programs advance .
  • Capital raised post-quarter strengthened runway: October registered direct and private placement grossed ~$15.7M, and combined Q3 private placement plus October financings generated ~$25.7M in cash and commitments, extending financial position into 2027; additional committed capital of $18.6M is scheduled through July 2026 .
  • Cortigent spin-off timing shifted due to U.S. federal government shutdown; the record date will be re-established once the SEC resumes normal operations (downshift from prior Q2 expectation of Q3/Q4 2025) .
  • No Wall Street consensus estimates were available from S&P Global for Q3 2025 EPS or revenue, limiting beat/miss analysis; no earnings call transcript was posted [GetEstimates Q3 2025] [ListDocuments earnings-call-transcript = 0].

What Went Well and What Went Wrong

What Went Well

  • LIBERATE-1 completed, validating NanoPortal’s initial clinical use: “Vivani achieved significant progress during the third quarter of 2025 including the successful completion of LIBERATE-1, marking the first clinical application of the Company’s proprietary platform technology, NanoPortal™.”
  • Clear differentiation in GLP-1 implants: “Vivani remains the only company developing ultra long-acting miniature GLP-1 implants designed for once- or twice-yearly dosing…offering both infrequent administration and peace of mind that, if necessary, treatment can be discontinued at any time.”
  • Strengthened financing and runway: October offerings grossed ~$15.7M; combined Q3 private placement and October financings yielded ~$25.7M in cash and commitments, securing development and runway into 2027 .

What Went Wrong

  • Continued operating losses as R&D scales: Q3 net loss was $6.5M vs. $6.0M YoY, driven by higher operating expenses; R&D rose to $4.5M (vs. $4.2M YoY), G&A to $2.2M (vs. $2.1M YoY) .
  • Cash balance declined to $4.0M at quarter-end (including restricted cash), necessitating reliance on subsequent financings and committed capital to fund pipeline .
  • Cortigent spin-off delayed due to government shutdown; record date withdrawal introduces timing uncertainty versus prior guidance (Q3/Q4 2025) .

Financial Results

P&L and EPS – Sequential trend (oldest → newest)

Metric ($USD Millions unless noted)Q1 2025Q2 2025Q3 2025
Research & Development Expense$4.217 $4.759 $4.519
General & Administrative Expense$2.340 $2.703 $2.206
Other Income, net$0.255 $0.318 $0.195
Net Loss$(6.302) $(7.144) $(6.530)
Net Loss per Share (EPS)$(0.11) $(0.12) $(0.11)

Cash – Quarter-end balances

MetricQ1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Restricted Cash ($USD Millions)$14.3 $8.1 $4.0

YoY comparison (Q3 2024 vs Q3 2025)

MetricQ3 2024Q3 2025
Research & Development Expense ($USD Millions)$4.203 $4.519
General & Administrative Expense ($USD Millions)$2.106 $2.206
Other Income, net ($USD Millions)$0.268 $0.195
Net Loss ($USD Millions)$(6.041) $(6.530)
Net Loss per Share (EPS)$(0.11) $(0.11)

Estimates vs. Actuals

MetricConsensus (Q3 2025)Actual (Q3 2025)
Revenue ($USD Millions)N/A*Not reported
EPS ($USD)N/A*$(0.11)

*Values retrieved from S&P Global. Consensus unavailable for VANI in Q3 2025.

Note: Company did not report revenue; statements present operating expenses and net loss consistent with development-stage status .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
NPM-139 (Semaglutide implant) Phase 1 startH1 2026“2026” clinical initiation (unspecified half) “First half of 2026” Raised specificity (timing refined)
NPM-139 Phase 2 dose-rangingFollowing Phase 1 & regulatory feedbackNot providedParallel investments to enable rapid initiation post-Phase 1 New detail (operational)
Cortigent spin-offAfter SEC resumes normal operationsQ3/Q4 2025 target window Record date withdrawn; new record date after SEC resumes Delayed (external factor)
Financial runwayThrough 2027“Into second half of 2026” tied to $10M Aug financing “Into 2027” via ~$25.7M Q3/Oct financings and commitments Extended runway

No financial guidance on revenue, margins, OpEx targets, or tax provided in Q3 materials .

Earnings Call Themes & Trends

No earnings call transcript was available for Q3 2025 [ListDocuments earnings-call-transcript=0]. Themes below reflect press releases and 8-K disclosures across quarters.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2025)Trend
GLP-1 implant strategy and differentiationEmphasis on once/twice-yearly subdermal implants; promising preclinical data for NPM-139; LIBERATE-1 enrollment and top-line timing Completion of LIBERATE-1; reiteration of unique positioning as only company with ultra long-acting miniature GLP-1 implants Confidence increasing; platform validation steps achieved
NPM-139 timing and development planClinical start targeted in 2026; prioritization supported by data and commercial success of semaglutide Phase 1 explicitly guided to H1 2026; Phase 2 preparation in parallel Timing refined; execution momentum
Financing and runway$3M (May) and $8.25M (Mar) private placements; CFO change; $10M (Aug) financing securing into H2’26 ~$15.7M Oct offerings; ~$25.7M total cash/commitments in Q3/Oct; runway into 2027; $18.6M committed through Jul’26 Runway extended; funding visibility improved
Cortigent spin-offTarget in Q3/Q4 2025; strategic intent to create focused entities Record date withdrawn due to government shutdown; new record date after SEC resumes Delayed by external regulatory timing
R&D execution and costsScaling costs as programs advance (R&D and G&A up YoY/QoQ) Continued investment with modest YoY net loss increase; Q3 R&D $4.5M; G&A $2.2M Investment phase sustained

Management Commentary

  • “Vivani achieved significant progress during the third quarter of 2025 including the successful completion of LIBERATE-1…This study paves the way for continued development of our growing pipeline of ultra long-acting miniature drug implants, including NPM-139 and NPM-133.” — CEO Adam Mendelsohn, Ph.D.
  • “Vivani remains the only company developing ultra long-acting miniature GLP-1 implants designed for once- or twice-yearly dosing…NanoPortal GLP-1 implants promise to address…poor medication adherence and poor tolerability.” — CEO Adam Mendelsohn, Ph.D.
  • “Our strategic prioritization of the semaglutide implant NPM-139 provides Vivani with significantly improved prospects…supported by…LIBERATE-1 and the positive preclinical weight loss data generated with NPM-139.” — CEO Adam Mendelsohn, Ph.D. (Q2)
  • “LIBERATE-1…achieved its primary objectives…the implant was generally well tolerated…no serious adverse events.” — CEO Adam Mendelsohn, Ph.D. (Aug 5 data release)

Q&A Highlights

  • No Q3 2025 earnings call transcript was posted; Q&A highlights unavailable [ListDocuments earnings-call-transcript=0].

Estimates Context

  • Wall Street consensus for Q3 2025 EPS and revenue was unavailable from S&P Global; as such, no beat/miss determination can be made for the quarter [GetEstimates Q3 2025].
  • Given development-stage status and absence of reported revenue, focus should remain on clinical timelines and financing runway rather than near-term consensus EPS variability .

Key Takeaways for Investors

  • Clinical milestones de-risk platform: LIBERATE-1 completion and clarified NPM-139 Phase 1 timing (H1 2026) strengthen visibility into first semaglutide implant data in humans and a potential rapid transition to Phase 2 .
  • Differentiated GLP-1 profile: Once/twice-yearly miniature implants address adherence and tolerability—key issues constraining real-world obesity outcomes; recent preclinical NPM-139 data sustained ~20% weight loss >6 months supports durability .
  • Financing materially extends runway: $15.7M October raise plus Q3 private placement commitments ($25.7M combined) and $18.6M committed through July 2026 extend runway into 2027, reducing near-term financing overhang .
  • Near-term catalysts: IND/Phase 1 initiation for NPM-139 in H1 2026; preparatory work for Phase 2 dose-ranging could compress timelines if Phase 1 and regulatory feedback are favorable .
  • Spin-off complexity: Cortigent timing now contingent on SEC operations resuming; prior Q3/Q4 2025 expectation has shifted, which may affect optionality and investor segmentation thesis in the interim .
  • Expense trajectory: R&D and G&A continue to rise with program advancement; Q3 net loss modestly widened YoY; monitor OpEx trend vs. milestone delivery to assess capital efficiency .
  • Trading lens: Stock likely reacts to clinical scheduling clarity (Phase 1 start window confirmation, any IND updates) and additional financing signals; execution against timelines is the core narrative driver in absence of revenue/consensus EPS .