Sign in

You're signed outSign in or to get full access.

NB

NAVIDEA BIOPHARMACEUTICALS, INC. (NAVB)·Q1 2022 Earnings Summary

Executive Summary

  • Q1 2022 was operationally focused on advancing the rheumatoid arthritis (RA) program; financials were in line with a clinical-stage profile: revenue $0, net loss $(3.0)M, EPS $(0.10) . Liquidity remains a key watch item with cash of $1.2M at quarter-end and a $1.5M bridge loan received from the Vice Chair; management guided runway “at least through the end of the second quarter” .
  • Clinical readthroughs were notably positive: NAV3-32 biopsy-comparison data showed 100% alignment of low-uptake scans with the fibroid pathotype in the first 11 patients, supporting tilmanocept as a biomarker to stratify likely non-responders to anti-TNFα therapy and a core Phase 3 indication .
  • Commercial groundwork progressed: LOI with MIM Software for automated quantification (commercial readout) and regulatory approval of Lymphoaim in India (import license process and manufacturing scale-up underway) offer incremental non-dilutive catalysts via milestones and future royalty/license flows .
  • No formal revenue/EPS guidance; estimate comparisons were not available from S&P Global for Q1 2022, limiting beat/miss framing. Focus near-term remains on clinical milestones, financing, and partner optionality (e.g., Jubilant MOU milestone gating to NAV3-32) .

What Went Well and What Went Wrong

What Went Well

  • NAV3-32 pathotyping signal: Tilmanocept SPECT uptake clearly differentiated fibroid vs. non-fibroid RA; seven patients with low uptake were all fibroid (7/7), while non-fibroid subjects showed >3x average uptake vs. fibroid, reinforcing utility for treatment selection and the Phase 3 thesis .
  • Phase 3 and ecosystem progress: Patient enrollment reached “double digits” and a third site opened; LOI in place with MIM to automate quantification, a critical step for scalable commercial workflows and potential parallel regulatory filing for the readout tool .
  • Geographic and IP momentum: Regulatory approval for Lymphoaim in India (milestone payments tied to regulatory and import license steps) and multiple allowed patent claims across jurisdictions underscore ongoing IP and ex-U.S. advancement .

What Went Wrong

  • No revenue and continued losses: Q1 revenue was $0 (vs. $124k prior-year), with operating loss $(3.0)M and cash of $1.2M, highlighting reliance on external financing and milestone receipts to fund operations .
  • Liquidity/financing overhang: Management disclosed dependence on a $1.5M bridge loan and continued pursuit of multi-year or milestone-based financings; runway guided only through end of Q2, elevating dilution/solvency risk if deals lag .
  • EU distribution lag commentary: Company indicated Europe experienced a logistics transition (Norgine to distributor), with an expectation for sales to pick up in coming quarters—implying recent sales execution has been light .

Financial Results

Quarterly trend (oldest → newest)

MetricQ3 2021Q4 2021Q1 2022
Revenue ($)$96,382 $50,348 $0
Research & Development ($)$1,048,786 $1,372,314 $1,169,254
Selling, General & Administrative ($)$1,469,375 $2,317,285 $1,810,029
Loss from Operations ($)$(2,421,779) $(3,639,251) $(2,979,283)
Net Loss ($)$(2,437,836) $(3,652,163) $(2,987,244)
EPS (basic/diluted)$(0.08) $(0.12) $(0.10)
Cash & Cash Equivalents ($)$7,176,211 $4,230,865 $1,217,114

Q1 YoY and sequential comparison

MetricQ1 2021Q4 2021Q1 2022Consensus (S&P Global)Beat/Miss
Revenue ($)$123,737 $50,348 $0 N/AN/A
Net Loss ($)$(2,966,892) $(3,652,163) $(2,987,244) N/AN/A
EPS ($)$(0.11) $(0.12) $(0.10) N/AN/A

Notes:

  • No gross margin or operating margin shown due to de minimis revenue and clinical-stage cost structure .

KPIs and operational metrics

KPIQ3 2021Q4 2021Q1 2022
NAV3-32 (imaging-to-biopsy) enrolled/biopsied9 subjects enrolled 11 completed imaging+biopsy 11 completed; clear fibroid vs. non-fibroid differentiation; further patients scheduled
NAV3-33 Phase 3 RA progressPreparing/initiation planned Enrollment underway; 2 sites open; size range refined to 200–672 patients Enrollment “double digits”; third site opened
Image quantification partner—LOI with MIM Software for commercial readout LOI ongoing; plan to validate on Phase 3 data; potential 510(k)/De Novo in parallel
India – Lymphoaim—File moved to administrative processing stage Regulatory approval received; import license and manufacturer onboarding in process
Financing—Engaged investment bank; options pursued $1.5M bridge loan closed; multi-year/milestone financings under evaluation

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent Guidance/DisclosureChange
Liquidity runwayQ2 2022Not previously specifiedCash on hand (incl. $1.5M bridge loan) sufficient “at least through the end of the second quarter” New disclosure
Commercial readout softwarePhase 3 timelineLOI with MIM (Q4) Plan to validate automated read on Phase 3 and normative data; pursue FDA submission in parallel Clarified execution path
India milestonesNear termUnder review (admin processing) Small milestone upon regulatory query completion and another upon import license; first expected by end of Q2 Timing update

No formal quantitative revenue/EPS/OpEx guidance was issued .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2021, Q4 2021)Current Period (Q1 2022)Trend
RA pathotyping (NAV3-32)9 enrolled; rationale to qualify CD206 biomarker; utility to guide therapy classes 11 completed; 7/7 low-uptake scans matched fibroid; non-fibroid >3x uptake; discrete classification achievable Strengthening signal
Phase 3 execution (NAV3-33)Initiation planning; protocol alignment with FDA Double-digit patient enrollment; third site opened; indications: early prediction and identification of low localizers Advancing
Imaging quantificationLOI with MIM for automated commercial readout Validate on Phase 3; parallel FDA pathway for software Execution detail added
Financing strategyEngaged bank; options pursued $1.5M bridge closed; preference for multi-year deal but open to milestone structures Liquidity watch
India commercializationFile in admin processing Regulatory approval achieved; import license process and new manufacturer onboarding De-risked approval
EU distributionDistribution setup ongoing Logistics transition complete; expect pick-up in sales in coming quarters Improving setup
Partnering (Jubilant MOU)Due diligence tied to NAV3-32; active Still active; milestone-based; NAV3-32 remains key Milestone-gated

Management Commentary

  • “Preliminary results… indicate that Tilmanocept uptake… is able to discreetly differentiate patients with the fibroid pathotype… from… diffuse myeloid or lympho-myeloid. Seven… had relatively low levels… SPECT… all seven… fibroid… non-fibroid… had on average, more than three times… imaging” .
  • “We continue to enroll into the Phase III trial… reached double digits… recently opened up a third site… indications… early prediction of treatment response… and… identify patients with low level of localization who are less likely to respond to anti TNF alpha therapy” .
  • “We have the letter of intent and are working closely with MIM Software… to be our commercial partner for imaging quantification… plan… to validate… on the Phase 3 data… and… go for… approval of the automated readout in parallel with the Phase 3” .
  • “Regulatory approval of Lymphoaim in India… There is a small milestone payment… as well as another due upon receipt of the import license. We’d expect that first payment by the end of this quarter” .
  • “With the receipt of the $1.5 million bridge loan… we believe we currently have enough cash on hand to continue operations, at least through the end of the second quarter” .

Q&A Highlights

  • NAV3-32 enrollment and scope: Management could expand beyond 24 if pathotype balance remains skewed; alternatively, could stop once fibroid vs. non-fibroid story is sufficiently supported .
  • Go-to-market focus: Rheumatologists expected to be primary decision-makers; nuclear med stakeholders supportive; payers expected to be interested given cost of ineffective anti-TNFα therapy; payer outreach on roadmap .
  • Automation/regulatory for readout: Plan to validate MIM software on Phase 3 and normative datasets; pursue FDA submission in parallel to Phase 3 completion, benchmarking automated output vs. nuclear medicine reads .
  • Financing approach: Preference for a larger multi-year financing if available; also evaluating milestone-based frameworks with “day one” money plus tranches .
  • India timeline and EU supply: Import license processing roughly three months post filing, with added lead time to qualify a new drug product manufacturer; EU saw logistics transition but is not out-of-stock; sales expected to improve .

Estimates Context

  • Wall Street consensus from S&P Global for Q1 2022 revenue and EPS was not available for NAVB at the time of analysis; therefore, no beat/miss determination is provided. Management did not issue formal quantitative guidance to anchor revisions .

Key Takeaways for Investors

  • NAV3-32 biopsy-comparison data materially de-risk the Phase 3 thesis by demonstrating clear discrimination of fibroid vs. non-fibroid pathotypes from baseline imaging—an actionable biomarker to avoid ineffective anti-TNFα therapies; continued positive readouts would strengthen partnering leverage .
  • Phase 3 RA is progressing (double-digit enrollment; third site opened), with a clear plan to industrialize image quantification via MIM and potentially align regulatory timing for the readout tool—important for commercial scalability .
  • Liquidity remains the central risk; quarter-end cash was $1.2M with a $1.5M bridge received and runway guided only through Q2. Expect financing headlines (multi-year or milestone structures) to be a primary stock driver near term .
  • India approval (Lymphoaim) introduces potential milestone receipts and future commercial flows after import license/manufacturing steps—helpful but not likely to be near-term transformative .
  • EU distribution friction appears to be resolving; watch for incremental royalty/license revenue in coming quarters from improved logistics .
  • The Jubilant MOU remains milestone-based and tied to NAV3-32 progress—further positive clinical updates could catalyze deal momentum or alternative partnering interest .
  • For trading, the cadence of clinical updates (NAV3-32, Phase 3 enrollment), financing outcomes, and India import-license milestones are the most likely catalysts; medium-term thesis hinges on executing Phase 3 and securing the ecosystem (automated readout, payer/reimbursement strategy) to enable adoption .