NAVIDEA BIOPHARMACEUTICALS, INC. (NAVB)·Q3 2022 Earnings Summary

Executive Summary

• Q3 2022 was a funding- and R&D-driven quarter: revenue was $0.008M vs $0.096M YoY, while net loss to common widened to $7.7M ($0.25 EPS) largely due to $2.6M legal fees recorded in SG&A pursuant to the CRG judgment; cash rose to $4.6M supported by a $6.2M rights offering, $0.8M reimbursement, and a $1.0M bridge loan .
• Clinical progress accelerated: Phase 3 RA trial sites expanded to 12 with above-average enrollment rates, and Phase 2B NAV3-32 showed 100% classification accuracy for fibroid vs non-fibroid RA pathotypes across 15 participants, reinforcing the biomarker narrative .
• Strategic optionality increased: the Jubilant Radiopharma MOU was terminated, enabling broader partnering discussions; management emphasized intent to fully fund the Phase 3 in 2023 and move toward NDA submission .
• Estimate context: S&P Global Wall Street consensus for NAVB was unavailable; no numerical beats/misses vs Street can be assessed for Q3 2022.

What Went Well and What Went Wrong

What Went Well

• Strong clinical signal clarity: “we've been able to clearly classify patients as either fibroid or non-fibroid… in all 15 participants,” supporting a non-invasive “virtual biopsy” approach for therapy prediction in RA .
• Trial productivity: Phase 3 sites increased to 12 and enrollment remained “above the average recruitment rate” for RA trials, positioning the study to trend to the lower end of the modeled 200–672 sample-size range based on observed response rates .
• Therapeutics pipeline momentum: preclinical constructs showed a “76%” average tumor growth reduction and additional mechanistic advances (e.g., SIRPα modulation), broadening optionality beyond diagnostics .

What Went Wrong

• Revenue and profitability deterioration: revenue fell to $0.008M from $0.096M YoY; net loss to common widened to $7.7M with EPS at $(0.25), driven by legal fees and higher SG&A .
• Legal overhang intensified: the Texas court awarded CRG ~$2.573M in attorney’s fees, and NAVB recorded $2.6M in SG&A tied to the judgment, pressuring near-term cash burn and equity .
• Minimal commercial traction: de minimis sales and higher opex underscore continued reliance on external financing until RA assets reach regulatory milestones .

Financial Results

Quarterly Trend (oldest → newest)

YoY Comparison (Q3 2021 vs Q3 2022)

KPIs and Operating Metrics

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We will continue the RA Phase 3 trial… fully fund the Phase 3 trial… our goal is to be fully funded in 2023.”
• “We’re maintaining above the average recruitment rate significantly… several sites identified 5–6 patients to bring in next month.”
• “We’re trending more towards the lower end of the trial size possibilities… 200 to 672 modeled range.”
• “We’ve been able to clearly classify patients as either fibroid or non-fibroid… in all 15 participants.”
• “Therapeutic constructs significantly reduced the rate of tumor growth by an average of 76%… with additional mechanism insights (SIRPα).”
• “Following the Texas Court ruling, we recorded $2.6M in legal fees in SG&A pursuant to the CRG judgment.”

Q&A Highlights

• Enrollment cadence and site quality: management leveraged prior high-performing imaging and rheumatology sites; maintained above-average enrollment despite recent site activations .
• Trial sizing clarity: response-rate mix suggests trending toward the lower end of 200–672 sample size; monitoring 3-month surrogate outcomes to calibrate recruitment .
• Biomarker robustness: 100% match for fibroid vs non-fibroid classification to date; rheumatology KOLs view this differentiation as clinically valuable for anti-TNF decisioning .
• Partnering landscape: with Jubilant exclusivity removed, management noted interest from nuclear pharma and RA-focused therapeutics players for biomarker usage and potential trial enrichment .
• Financing path: Maxim to continue efforts; rights offering completed; Board intent remains to secure multi-year capital to fund Phase 3 to NDA submission .

Estimates Context

• S&P Global Wall Street consensus estimates for NAVB were unavailable for Q3 2022; therefore, no quantitative comparison vs consensus can be provided. The company’s micro-cap status and limited sell-side coverage likely contributed to unavailable consensus data.

Key Takeaways for Investors

• Clinical derisking: strengthening biomarker evidence and above-average Phase 3 enrollment are constructive catalysts; continued site productivity could compress timelines and support earlier NDA filing momentum .
• Funding remains the gating item: despite $6.2M rights proceeds and $1.8M additional inflows, management still needs full Phase 3 funding; watch for capital commitments or strategic partnerships in 2023 .
• Legal overhang is material near term: the CRG fee award and booked SG&A impact constrained P&L and equity; resolution paths and cash management are key to sustaining Phase 3 pace .
• Commercial optionality improved: termination of Jubilant MOU opens broader discussions; biomarker utility could enable trial enrichment services or co-development with RA drug makers .
• Revenue/EPS not indicative of value near term: de minimis revenue and elevated SG&A make net metrics volatile; focus on clinical milestones and financing rather than quarterly GAAP optics .
• Watch pipeline read-throughs: oncology and inflammatory constructs’ 76% tumor growth reduction and macrophage-targeting mechanisms expand the strategic narrative beyond RA .
• Trading implications: catalysts include Phase 3 enrollment updates, NAV3-32 completion/publication, funding announcements, and partnering news; litigation updates may drive volatility .

Additional Relevant Press Releases in Q3 2022

• Nine new Phase 3 RA sites opened and Jubilant MOU terminated (broadening partnering flexibility) .
• CRG litigation fee ruling (~$2.573M) disclosed; NAVB assessing next steps .