On May 12, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the first quarter for the period ended March 31, 2022 (Press release, Navidea Biopharmaceuticals, MAY 12, 2022, View Source [SID1234614407]).
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First Quarter 2022 Highlights and Subsequent Events
Continued enrollment into the Company’s NAV3-33 Phase 3 trial in rheumatoid arthritis ("RA") titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis."
Announced positive preliminary results from the Company’s ongoing NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Two non-overlapping classes that align with the fibroid and non-fibroid histological pathotypes were identified, supporting the hypothesis that these classes can be identified by Tc99m tilmanocept imaging.
Received regulatory approval for Lymphoaim in India.
Filed two new provisional patent applications. Both are related to new methods to maximize target-tissue uptake and reduce off-target binding. These have important implications for pipeline applications.
Received Notices of Allowed Claims for patent applications in the United States, Israel, Australia, and Japan.
Closed on a $1.5 million bridge loan from the Company’s Vice Chair of the Board of Directors, John K. Scott, Jr.
Adopted a plan designed to protect the Company’s net operating loss and tax credit carryforwards.
Continued to work on financing for the Company. We have engaged with multiple investment banks and options are being pursued.
Settled litigation with Platinum-Montaur Life Sciences LLC.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. The NAV3-33 Phase 3 and NAV3-32 Phase 2b trials continue to enroll. We are pleased with the preliminary positive results from the NAV3-32 study that thus far support our hypothesis that we can distinguish between fibroid and non-fibroid pathotypes of RA with a single scan." Dr. Rosol continued, "Concurrent with all of this, we continue to make progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."
Financial Results
Total net revenues for the first quarter of 2022 were $0, compared to $124,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debts previously written off in 2015 coupled with recognition of license revenue related to transitional sales in Europe in 2021.
Research and development expenses for the first quarters of both 2022 and 2021 were $1.2 million. Decreases in Manocept diagnostic and Tc99m tilmanocept development costs and decreased regulatory consulting expenses were offset by increased Manocept therapeutic development costs, employee compensation including fringe benefits and incentive-based awards, and recruiting expenses.
Selling, general and administrative expenses for the first quarter of 2022 were $1.8 million, compared to $2.2 million in the same period in 2021. Decreases in employee compensation including fringe benefits and incentive-based awards, legal and professional services, general office expenses, travel, franchise taxes and investor relations costs were offset by increased director fees, losses on the abandonment of certain intellectual property and increased insurance costs.
Navidea’s net loss attributable to common stockholders for the first quarter of 2022 was $3.0 million, or $0.10 per share, compared to $3.0 million, or $0.11 per share, for the same period in 2021.
Navidea ended the first quarter of 2022 with $1.2 million in cash and cash equivalents.
Conference Call Details
Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.