Navidea Biopharmaceuticals, Inc.

Total revenue was approximately $1,000 in Q4 2022 versus $50,000 in Q4 2021; full-year revenue was $66,000 versus $532,000 in 2021. Research and development expense was $1.0 million in Q4 2022 versus $1.4 million a year earlier, and $6.0 million for full-year 2022 versus $5.1 million in 2021. SG&A was $1.3 million in Q4 2022 versus $2.3 million in Q4 2021, and $8.0 million for full-year 2022 versus $7.5 million in 2021; SG&A included $2.6 million of legal fees tied to the CRG judgment. Net loss attributable to common stockholders was $3.5 million, or $0.11 per share, in Q4 2022 versus $3.7 million, or $0.12 per share, in Q4 2021; full-year net loss was $17.2 million, or $0.56 per share, versus $11.7 million, or $0.40 per share in 2021. Navidea ended Q4 2022 with approximately $2 million in cash and cash equivalents. No formal revenue or earnings guidance was given, but management reiterated a goal to be fully funded this year and said it expects to regain NYSE compliance by the end of the cure period. Timelines for some commercial and revenue projections may slip because of a resource-limited environment and incomplete site activation.

Michael Rosol’s message was that the company is advancing across its RA diagnostic program and broader macrophage-targeting pipeline, while trying to build toward key inflection points rather than rush early partnering. He emphasized the company’s hypothesis that tilmanocept imaging can identify RA pathotypes and predict response to anti-TNF therapy, and said the new data strengthen conversations with potential pharma partners. His tone was candid but optimistic, repeatedly noting that progress is being made despite limited resources.

Joseph Meyer reported very small Q4 revenue and continued losses, with Q4 revenue of about $1,000, Q4 net loss of $3.5 million, and year-end cash and equivalents of about $2 million. He also detailed that R&D rose to $6.0 million for 2022, SG&A rose to $8.0 million, and SG&A included $2.6 million of legal fees related to the CRG judgment. Erika Eves added that the financing effort should help address the NYSE cure requirement, and management signaled that capital infusion is the immediate priority.

The most notable questions focused on liquidity, NYSE compliance, Lymphoseek’s stalled international performance, and whether RA revenue projections remain realistic. Management said cash is tight, acknowledged a resource-limited environment, and said the Board is actively working on financing; on NYSE compliance, Erika said expectations are that Navidea will regain compliance by the end of the cure period. On Lymphoseek, Rosol said Europe has a viable low-cost competitor and that pricing/market strategy has been a challenge, but he still believes the product has advantages and the company is in partner discussions. On the RA projections, management said the long-term market potential still looks solid, but timing could be pushed out if site expansion and enrollment proceed more slowly than originally modeled.