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NAVIDEA BIOPHARMACEUTICALS, INC. (NAVB)·Q4 2021 Earnings Summary

Executive Summary

  • Q4 revenue fell to $0.05M (–77% YoY; –48% QoQ) on lower NIH SBIR grant revenue and reduced European Tc99m tilmanocept royalties; net loss to common widened to $3.65M ($0.12) vs $3.00M ($0.11) YoY as SG&A rose on CEO separation and other costs .
  • Cash ended at $4.23M (down from $7.18M in Q3), highlighting near‑term financing needs; management noted ongoing work with an investment bank on funding options .
  • Strategically, NAVB initiated and began enrolling its Phase 3 RA study (NAV3‑33), completed enrollment of the RA normative database (NAV3‑35), continued NAV3‑32 (11 patients completed), and signed an LOI with MIM Software to commercialize automated image quantification—key to scaling the RA product .
  • No formal financial guidance and no usable Wall Street consensus were available for Q4; near‑term stock catalysts hinge on financing updates and clinical progress in RA imaging and therapeutic constructs .

What Went Well and What Went Wrong

What Went Well

  • “We initiated and have enrolled into our Phase 3 trial in RA...” and completed enrollment for the RA normative database (NAV3‑35), advancing the RA pipeline toward pivotal validation .
  • Signed LOI with MIM Software to deliver a “fully automated” quantitative image readout, enabling reproducible, scalable RA imaging reads for commercial rollout .
  • Clinical execution momentum: 11 patients completed imaging+biopsy in NAV3‑32 with 4–5 in screening; external validation signs include MGH atherosclerosis plaque imaging abstract with “promising” localization data presented in Feb 2022 .

What Went Wrong

  • Revenue declined sharply as SBIR grants and EU tilmanocept royalties decreased, partially offset by debt recovery and Cardinal R&D reimbursements; SG&A increased on CEO separation, consulting, board comp, and insurance, pressuring losses .
  • Cash fell to $4.23M from $7.18M QoQ; management acknowledged active financing efforts, underscoring funding risk into clinical milestones .
  • Limited external visibility: no formal financial guidance; Phase 3 RA sample size could range 200–672 depending on responder mix, implying timelines and costs may vary; no early outcomes disclosed for Phase 3 .

Financial Results

Sequential trend (oldest → newest)

MetricQ2 2021Q3 2021Q4 2021
Revenue ($)$261,046 $96,382 $50,348
Gross Profit ($)$261,046 $96,382 $50,348
R&D ($)$1,498,056 $1,048,786 $1,372,314
SG&A ($)$1,432,610 $1,469,375 $2,317,285
Loss from Operations ($)$(2,669,620) $(2,421,779) $(3,639,251)
Net Loss to Common ($)$(2,674,039) $(2,437,835) $(3,652,163)
EPS (basic & diluted)$(0.09) $(0.08) $(0.12)
Cash & Equivalents ($)$7,114,103 $7,176,211 $4,230,865

YoY comparison

MetricQ4 2020Q4 2021
Revenue ($)$219,251 $50,348
Gross Profit ($)$219,251 $50,348
R&D ($)$1,271,141 $1,372,314
SG&A ($)$1,748,680 $2,317,285
Loss from Operations ($)$(2,800,570) $(3,639,251)
Net Loss to Common ($)$(3,003,680) $(3,652,163)
EPS (basic & diluted)$(0.11) $(0.12)

KPIs and Operating Milestones

KPIQ2 2021Q3 2021Q4 2021
RA Phase 3 (NAV3‑33) statusPreparing; EOP2 FDA set for 9/1/21 Post EOP2; protocol finalized; initiation planned Initiated and enrolling; 2 sites open; another in process
RA NAV3‑32 (imaging vs biopsy)Sites opened; enrollment ongoing 3rd site opened; enrollment ongoing 11 completed; 4–5 in screening
RA NAV3‑35 (normative database)>115 enrolled of 135 target Near full enrollment Enrollment completed
Image quantification/commercialization——LOI signed with MIM Software for automated reads
Cash & Equivalents ($)$7.11M $7.18M $4.23M

Context/why: Revenue decline driven by lower grant and EU royalty/license revenue; SG&A up due to CEO separation and other costs; partial offsets from debt recovery and Cardinal R&D reimbursements .

Guidance Changes

The company did not provide formal quantitative guidance for revenue, EPS, margins, or OpEx. Management’s commentary focused on clinical progress and financing efforts; no numeric outlook was issued .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2021, Q3 2021)Current Period (Q4 2021)Trend
RA program (Phase 3, design, enrollment)Preparing for 9/1/21 FDA EOP2; Phase 3 launch anticipated Phase 3 initiated and enrolling; 2 sites open; target size now 200–672 based on responder mix Progressing from planning to active enrollment
RA NAV3‑32 (imaging vs biopsy)Sites opened; enrollment ongoing 11 completed; balancing RA subtypes; additional in screening Steady enrollment; nearing full cohort
RA normative database (NAV3‑35)>115 enrolled; near full Enrollment completed; used to improve discrimination and prediction Completed; supports Phase 3 analytics
Image quantification/commercialization——LOI with MIM for automated reads; pilot shows robust reproduction of proprietary algorithm
Financing/capital—Leadership transition; noted call format constraints “Working on financing” with investment bank; options pursued
EU distribution/royaltiesConsulting for EU distribution noted —Distribution setup largely resolved; seeking EU partners
Regulatory/legal/IPUpcoming FDA EOP2; NIH/U.S. patents Continued IP filings; coordination with Cardinal on prosecution Broadening IP; coordinated strategy
Additional indicationsAtherosclerosis imaging at MGH completed; PET agent work MGH abstract presented; promising plaque localization; Ga‑68 preclinical progress Encouraging external data flow
India Lymphoseek (Lymphoaim)——File moved to administrative processing; timing TBD

Management Commentary

  • “We initiated and have enrolled into our Phase 3 trial in RA...” with goals to predict early treatment response to anti‑TNFα and identify likely non‑responders .
  • “We have signed a letter of intent with... MIM Software... [to] develop a fully automated application that can robustly reproduce our quantitative imaging reads...” enabling rapid, reproducible scaling .
  • On financing: “We have engaged with an investment bank and options are being pursued... the Board of Directors and senior management are working on this tirelessly.” .
  • On NAV3‑32: “We have 11 subjects who have completed both imaging and biopsy with an additional 4 to 5 subjects in screening.” .
  • On external validation: MGH investigator‑initiated atherosclerosis study presented an abstract in Feb 2022 with “promising” localization in plaques .

Q&A Highlights

  • TAMs therapeutic timeline: Early‑2024 IND remains “in reach,” contingent on ongoing preclinical progress .
  • Competitive positioning vs blood‑based assays: Management emphasized joint‑level activity measurement as a core advantage and positive KOL feedback if trial data continue to hold .
  • Phase 3 sample size/statistics: Trial range reduced to 200–672; midpoint 523 reflects conservative planning; sizing driven by anti‑TNF responder/non‑responder mix to achieve sensitivity/specificity and PPV/NPV targets .
  • Operations/commercial: WorldCare remains the imaging CRO for trials; MIM Software targeted for commercial readout automation and workflow at scale .
  • Corporate/IR: SEC indicated it does not intend to review the S‑1 at this time; certain warrants outstanding; no Keystone Series D conversions as of the call .

Estimates Context

  • S&P Global consensus EPS and revenue estimates for NAVB were unavailable for Q4 2021 via our data access. As a result, we cannot provide a vs‑consensus comparison for this quarter. Management did not issue formal financial guidance in Q4 materials .

Key Takeaways for Investors

  • Revenue mix volatility and a small base amplify P&L swings; Q4 declines tied to grants and EU royalties while SG&A step‑up (CEO separation, consulting/board costs) widened losses .
  • Liquidity is the near‑term swing factor: cash fell to $4.23M; financing progress with an investment bank is critical to sustaining clinical momentum and is a potential stock catalyst .
  • RA franchise is executing: Phase 3 initiated/enrolling; NAV3‑32 and NAV3‑35 deliver clinical/analytical underpinnings; LOI with MIM strengthens commercialization pathway for automated reads .
  • External validators (MGH, UAB) and IP expansion support platform credibility across imaging and therapeutics, broadening optionality beyond RA .
  • Watch for: financing updates; Phase 3 site expansion/enrollment cadence; NAV3‑32 data milestones; MIM agreement finalization; India Lymphoaim approval progression; EU distribution/partnering developments .
  • Near‑term trading setup: sensitive to any funding announcement, trial enrollment updates, or tangible partnering/commercialization steps (e.g., MIM deal finalization) given the micro‑cap base and lack of formal guidance .