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ORGANOVO HOLDINGS, INC. (ONVO)·Q4 2025 Earnings Summary

Executive Summary

  • Q4 FY2025 update focused on liquidity and listing status: Organovo reported preliminary cash and cash equivalents of $11.3M at March 31, 2025 and net cash utilization of $2.0–$2.2M for the quarter; management guided that ONVO expects to meet Nasdaq continued listing requirements (≥$1.00 bid for 10 consecutive days and ≥$2.5M stockholders’ equity) pending confirmation .
  • Balance sheet trajectory pre-Q4 showed cash declining to $1.161M at Dec 31, 2024 and stockholders’ equity at $0.364M; the March 25, 2025 asset sale to Eli Lilly (FXR program) provided $10.0M upfront (with $9.0M received, $1.0M escrow) and potential milestones up to $50.0M, underpinning the Q4 liquidity improvement .
  • Results vs estimates: S&P Global Wall Street consensus estimates for ONVO were unavailable; no comparison to EPS or revenue consensus could be made. Note: Consensus data via S&P Global unavailable for ONVO (no CIQ mapping).
  • Near-term catalysts: confirmation of Nasdaq compliance, expected $5M milestone within 12 months tied to Phase 2 start of the FXR agonist sold to Lilly, and full financials release timing indicated in the press release .

What Went Well and What Went Wrong

What Went Well

  • Liquidity inflection: preliminary cash and equivalents increased to approximately $11.3M at fiscal year-end, supported by the FXR asset sale to Lilly and financing activities; net cash burn moderated to ~$2.0–$2.2M in Q4 .
  • Listing status progress: ONVO’s stock closed above the $1.00 minimum bid since March 21, 2025; management “expects to meet the requirements for continued listing on the Nasdaq Capital Market” pending confirmation (“expects to meet all requirements”) .
  • Strategic monetization: FXR asset sale terms include $10.0M upfront (with $9.0M received at close, $1.0M in escrow for 15 months) and up to $50.0M in milestones, with management “reasonably” expecting a $5M milestone within 12 months upon Phase 2 commencement .

What Went Wrong

  • Core P&L still loss-making: prior quarter net losses remained sizable—$(3.447)M in Q3, $(2.549)M in Q2, $(3.344)M in Q1; revenue stayed de minimis driven by small royalties and Mosaic product sales .
  • Going concern risk before Q4: as of Dec 31, 2024, stockholders’ equity was $0.364M and cash $1.161M, with negative operating cash flow of $(7.426)M for the first nine months; management disclosed substantial doubt about going concern absent additional financing .
  • Operational setbacks: Mosaic commercial operations ended in Q3 due to underperformance; remaining inventory was written off/transferred to R&D, increasing reported R&D expenses .

Financial Results

Note: Q4 FY2025 press release furnished preliminary cash and burn but did not provide revenue/EPS; estimates unavailable.

MetricQ1 2025Q2 2025Q3 2025Q4 2025
Revenue ($USD Thousands)$39 $30 $24 n/a (not disclosed in press release)
Net Loss ($USD Thousands)$(3,344) $(2,549) $(3,447) n/a
EPS ($USD)$(0.23) $(0.14) $(0.19) n/a
Cash and Equivalents ($USD Millions)$6.187 $3.174 $1.161 $11.3 (prelim)
Net Cash Utilization ($USD Millions)n/an/an/a$2.0–$2.2

Segment breakdown (Revenue):

Segment MetricQ1 2025Q2 2025Q3 2025Q4 2025
R&D Royalty Revenue ($USD Thousands)$25 $28 $15 n/a
Mosaic Product Revenue ($USD Thousands)$14 $2 $9 n/a (Mosaic ended in Q3)

KPIs:

KPIQ1 2025Q2 2025Q3 2025Q4 2025
Stockholders’ Equity ($USD Thousands)$6,662 $3,680 $364 ≥$2,500 (management believes, pending Nasdaq confirmation)
Weighted Avg Shares (Basic/Diluted)14,664, approx 17,995 18,057 n/a

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Nasdaq continued listing compliance (min bid ≥$1.00 for 10 days; equity ≥$2.5M)Q4 FY2025No prior formal guidance providedExpects to meet requirements; stock has closed ≥$1.00 since Mar 21, 2025; believes equity ≥$2.5M (pending Nasdaq confirmation) New (Raised confidence)
Cash and Cash EquivalentsFY-end Mar 31, 2025n/aPreliminary $11.3M New
Net Cash UtilizationQ4 FY2025n/a~$2.0–$2.2M New
FXR asset milestonesNext 12 monthsn/aReasonably expects $5M milestone upon Phase 2 start; total potential milestones up to $50M New

Earnings Call Themes & Trends

Note: No Q4 FY2025 earnings call transcript located.

TopicPrevious Mentions (Q1 & Q2 FY2025)Current Period (Q4 FY2025)Trend
Nasdaq listing/bid priceReceived July 18, 2024 bid-price notice; considering reverse split; substantial doubt comments in filings Expects compliance; ≥$1.00 since Mar 21; equity threshold believed met, pending confirmation Improving
Liquidity & cash runwayCash $6.187M (Q1), $3.174M (Q2), $1.161M (Q3); going concern disclosures Preliminary cash $11.3M; Q4 burn $2.0–$2.2M Improving (post-asset sale)
FXR program strategyFocus on FXR314 in IBD; Phase 2a UC planned 2025; MASH data supportive FXR program sold to Lilly with milestones; company expects $5M milestone on Phase 2 start Monetized/partnered
Mosaic segmentLaunched FY2025; low revenue; inventory buildup Mosaic ended Q3; inventory written off/transferred to R&D Wound down
Legal/contingenciesH.C. Wainwright complaint, $0.6M accrual by Q2/Q3 No new Q4 detail in press release Stable/ongoing

Management Commentary

  • “Organovo…reported preliminary unaudited cash…approximately $11.3 million as of…March 31, 2025. Organovo’s preliminary net cash utilization during the fourth quarter…was approximately $2.0 - $2.2 million.”
  • “The Company…expects to meet the requirements for continued listing on the Nasdaq Capital Market…Nasdaq requires a minimum of 10 consecutive trading days where the stock closes at a minimum bid price of $1.00, and the Company has closed above $1.00 since March 21, 2025.”
  • “Organovo completed the sale…to Eli Lilly…of the Company’s FXR program…consideration…$10.0 million…$9.0 million was paid at closing and the remaining $1.0 million was deposited into escrow…[and] potential milestone payments…up to $50.0 million.”
  • “It currently reasonably expects to receive a $5M milestone payment within the next 12 months associated with the anticipated start of a Phase 2 clinical trial for the FXR agonist that it recently sold.”

Q&A Highlights

No Q4 FY2025 earnings call transcript found; no Q&A highlights available.

Estimates Context

  • Wall Street consensus via S&P Global was unavailable for ONVO for Q4 FY2025 and FY2025 (no CIQ mapping returned by the estimates tool). As a result, we cannot provide comparisons vs consensus estimates for revenue or EPS for this quarter. Note: Consensus data via S&P Global unavailable for ONVO.

Key Takeaways for Investors

  • Liquidity reset: Post-Lilly FXR asset transaction, ONVO’s prelim year-end cash of $11.3M and modest Q4 burn (~$2.0–$2.2M) reduce near-term financing risk vs Q3 levels .
  • Listing risk abates: Sustained ≥$1.00 bid (since Mar 21) and management’s belief of ≥$2.5M equity improve odds of continued Nasdaq listing; formal confirmation remains a catalyst .
  • Pipeline strategy pivots: FXR program monetized; milestone path (near-term $5M on Phase 2 start) offers non-dilutive funding potential; monitor Lilly’s trial initiation timeline .
  • Core operations still loss-making: Minimal revenue and continued net losses underscore need for disciplined opex and additional strategic BD to fund R&D .
  • Mosaic exit reduces distraction: Segment wind-down and inventory write-offs clarify focus on R&D and external monetization/partnerships .
  • Near-term trading: Stock likely sensitive to Nasdaq confirmation and any milestone newsflow; absence of consensus estimates amplifies headline sensitivity to liquidity updates .
  • Medium term: Watch for broader partnering on 3D tissue/disease model platform to create recurring royalty/fee streams and reduce capital intensity .

Appendix: Additional Data Points

  • Q3 FY2025 equity and cash at Dec 31, 2024: stockholders’ equity $0.364M; cash $1.161M .
  • Financing activities in FY2025 to date: ATM proceeds ~$$1.7M through Dec 31, 2024; May 2024 public offering net ~$4.5M; legal accrual related to H.C. Wainwright complaint ~$0.6M recorded by Q2/Q3 .