Navidea Biopharm Stock Price, News & Analysis

Navidea Biopharmaceuticals announced preliminary results from its NAV3-32 Phase 2B study regarding Tc99m tilmanocept imaging in rheumatoid arthritis (RA) patients. The data from 11 patients indicate that Tc99m tilmanocept uptake correlates with macrophage involvement in joint inflammation, allowing differentiation between fibroid and other RA pathotypes. This study aims to establish the imaging's relationship to RA pathobiology and facilitate better therapy decisions. A business update conference call is scheduled for April 20, 2022 at 5:00 p.m. (EDT).

Navidea Biopharmaceuticals (NYSE American: NAVB) announced an updated third-party asset valuation for its Rheumatoid Arthritis (RA) diagnostic candidate, Tc99m tilmanocept, conducted by LifeSci Consulting. This assessment focused on the U.S. and EU markets, revealing potential peak combined sales of $1.2 billion annually under base-case assumptions, with an upside scenario of $2.6 billion. The company is advancing a Phase 3 trial to evaluate Tc99m tilmanocept's efficacy as an early treatment response predictor in RA patients switching to anti-TNFα therapy.

Navidea Biopharmaceuticals announced significant intellectual property advancements, receiving a Notice of Allowance for a U.S. patent on therapies for leishmaniasis and a Decision of Grant from the Japan Patent Office for targeted drug delivery methods. The U.S. patent application emphasizes the use of mannosylated dextran-based vehicles for effective treatment, reflecting a market potential given the WHO estimates of 700,000-1,000,000 new cases yearly. The Japanese patent enhances protections for the Manocept platform, crucial for future development in cancer and leishmaniasis therapies.

Navidea Biopharmaceuticals (NYSE American: NAVB) announced regulatory approval for Lymphoaim (Tc99m tilmanocept) by India's Central Drugs Standard Control Organisation. This agent is designed for imaging and intraoperative detection of sentinel lymph nodes in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma. Sayre Therapeutics will manage commercialization in India under an exclusive distribution agreement, anticipated to generate new revenue for Navidea and advance its pipeline products.

Navidea Biopharmaceuticals (AMEX: NAVB) has initiated a Section 382 Rights Agreement to safeguard its net operating loss carryforwards (NOLs) and tax assets. As of December 31, 2021, the company had approximately $164 million in federal NOLs and $9.1 million in R&D tax credits. The Board declared a preferred share purchase right for each outstanding share, effective April 12, 2022, to deter significant ownership changes. Additionally, Navidea has secured a $2.5 million bridge loan from major shareholder John K. Scott to support working capital needs during financing efforts.

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) received a notification from the NYSE American for not meeting the $6.0 million stockholders’ equity requirement as of January 28, 2022. The company is also non-compliant with additional equity requirements, having reported only $624,743 in stockholders’ equity by December 31, 2021. Navidea submitted a compliance plan, accepted by NYSE American on April 8, 2022, with a deadline to regain compliance by July 28, 2023. Navidea's common stock will continue trading under NAVB, marked with a '.BC' designation indicating non-compliance.

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) appointed Dr. Kenneth Berger as Senior Regulatory Consultant and welcomed back Richard McFerron as former Director of Regulatory Affairs. Dr. Berger brings significant experience in regulatory submissions and drug development. McFerron had previously contributed to the approval of Lymphoseek and will support ongoing projects in Rheumatoid Arthritis diagnostics. Furthermore, the Company disclosed an audit opinion indicating concerns about its ability to continue as a going concern, as detailed in its 2021 Annual Report.

Navidea Biopharmaceuticals reported its financial results for Q4 and year-end 2021, with total net revenues dropping to $50,000 in Q4 from $219,000 in Q4 2020, and full-year revenues at $532,000 compared to $914,000 in 2020. Research and development expenses rose to $1.4 million in Q4, while SG&A expenses increased to $2.3 million. The net loss for Q4 was $3.7 million, or $0.12 per share, compared to $3.0 million, or $0.11 per share, in the prior year. As of year-end, cash and equivalents stood at $4.2 million.