On November 14, 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 three-month and nine-month periods ended September 30, 2022 (Press release, Navidea Biopharmaceuticals, NOV 14, 2022, View Source [SID1234624038]).
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Third 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 the opening of nine additional sites for recruitment into the Company’s pivotal NAV3-33 Phase 3 clinical trial, for a total of 12 sites now open and recruiting.
Presented positive results from the Company’s completed NAV3-31 Phase 2B clinical study as well as the positive preliminary results of its ongoing NAV3-32 Phase 2B study at the Annual Meeting of the American College of Rheumatology held November 10-14, 2022 in Philadelphia, PA.
Presented results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held November 8-12, 2022 in Boston, MA. Results demonstrate efficacy of new constructs at macrophage phenotype change and in a mouse tumor model.
Received gross cash proceeds of $6.2 million in connection with the Rights Offering.
Received $800,000 from a strategic partner as reimbursement for certain manufacturing and research and development expenses.
Received an additional $1.0 million under a bridge loan from the Company’s Vice Chair of the Board of Directors, John K. Scott, Jr.
Appointed Joshua M. Wilson, a seasoned banking and finance executive with more than 23 years of financial services and family office experience, to the Company’s Board of Directors.
Received notification of issuance of patent from the USPTO and the state of Israel for the application titled, "Compounds And Compositions For Treating Leishmaniasis And Methods Of Diagnosis And Treating Using Same" (Patent No. US 11,369,680 B2; State of Israel Patent Office No. 265830).
Filed a provisional patent application describing a new degradable linker for dexamethasone and paclitaxel containing Manocept therapeutic constructs. These constructs are being evaluated preclinically for effects on macrophages and in animal models of oncology and inflammatory indications.
Announced publication of a manuscript titled "Increased Macrophage Specific Arterial Inflammation Relates Uniquely to Non-calcified Plaque and Specific Immune Activation Pathways in People with HIV: A Targeted Molecular Imaging Approach," based on work performed at the Massachusetts General Hospital ("MGH") and Harvard Medical School, Boston MA, and sponsored by the Company. The research, appearing in The Journal of Infectious Diseases (PMID: 35856671), was led by Principal Investigator Steven Grinspoon, MD, Chief of the Metabolism Unit at MGH and Professor of Medicine at Harvard Medical School.
Announced publication of a manuscript titled "Tilmanocept as a novel tracer for lymphatic mapping and sentinel lymph node biopsy in melanoma and oral cancer," based on work performed at the Crown Princess Mary Cancer Centre ("CPMCC") at the University of Sydney, in Sydney, Australia. The research, appearing in the ANZ Journal of Surgery (PMID: 35848587), was led by Principal Investigator Dr. Muzib Abdul-Razak, MBBS, FRACS, FRCSE, MCh., of the Faculty of Medicine, Department of Surgical Oncology and Head and Neck Surgery in the CPMCC at the University of Sydney.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The company 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 IND filing and clinical trials. The promising results to date of our RA trials and the preclinical studies of our therapeutics demonstrate the significant potential of our macrophage-targeting Manocept platform."
Financial Results
Total revenues for the three-month period ended September 30, 2022 were approximately $8,000, compared to $96,000 for the same period in 2021. Total revenues for the nine-month period ended September 30, 2022 were $65,000, compared to $481,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debts previously written off in 2015, the 2021 receipt of reimbursement from Cardinal Health 414, LLC of certain research and development ("R&D") costs, decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, and decreased license revenue from transitional sales of Tc99m tilmanocept in Europe.
Research and development expenses for the three-month period ended September 30, 2022 were $1.2 million, compared to $1.0 million for the same period in 2021. R&D expenses for the nine-month period ended September 30, 2022 were $4.1 million, compared to $3.8 million for the same period in 2021. The increase was primarily due to increased employee compensation including incentive-based awards offset by decreases in drug project expenses and regulatory consulting expenses.
Selling, general and administrative ("SG&A") expenses for the three-month period ended September 30, 2022 were $3.6 million, compared to $1.5 million for the same period in 2021. SG&A expenses for the nine-month period ended September 30, 2022 were $6.7 million, compared to $5.1 million for the same period in 2021. Following the ruling by the Texas Court in August 2022, the Company recorded $2.6 million in legal fees in SG&A pursuant to the CRG judgment. Increases in legal and professional services, insurance, director fees, losses on the abandonment of certain intellectual property, and depreciation and amortization were partially offset by decreases in employee compensation including fringe benefits and incentive-based awards, expenses related to European operations, investor relations and shareholder services, travel, facilities costs, general office expenses and franchise taxes.
Navidea’s net loss attributable to common stockholders for the three-month period ended September 30, 2022 was $7.7 million, or $0.25 per share, compared to $2.4 million, or $0.08 per share, for the same period in 2021. Navidea’s net loss attributable to common stockholders for the nine-month period ended September 30, 2022 was $13.7 million, or $0.45 per share, compared to $8.1 million, or $0.28 per share, for the same period in 2021.
Navidea ended the third quarter of 2022 with $4.6 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.