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Navidea Biopharmaceuticals Reports First Quarter 2019 Financial Results

Nachrichtenquelle: Business Wire (engl.)
08.05.2019, 22:05  |  159   |   |   

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the first quarter of 2019. Navidea reported total revenues for the quarter of $136,000. Net loss attributable to common stockholders was $2.4 million.

“During the first quarter, Navidea received clearance from the FDA to commence the Phase 2b trials and solid guidance on the final pivotal trial for our rheumatoid arthritis diagnostic program,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “The Company remains fully focused on completing these trials and bringing this ground-breaking diagnostic to the market.”

First Quarter 2019 Highlights and Subsequent Events

  • Executed a Stock Purchase Agreement for up to $3.0 million with an existing investor
  • Received feedback from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s planned clinical studies that will evaluate joint disease in patients with rheumatoid arthritis (“RA”) and monitor patient response to therapy
  • Began enrolling patients in a Phase 2b trial entitled, “Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (“TUV”) on Tc99m Tilmanocept Planar Imaging” (ClinicalTrials.gov Identifier: NCT03938636)
  • Announced that Professor Mike Sathekge, MBChB, M. Med (Nuclear Medicine), PhD, Professor and Head of the Department of Nuclear Medicine in the Faculty of Health Sciences at the University of Pretoria/Steve Biko Academic Hospital, plans to initiate a comparative study to explore using 68Ga tilmanocept as an aid in tuberculosis (“TB”) patient management while contributing to the better understanding of the biology of TB granulomas
  • Effected a one-for-twenty reverse stock split and received notification of stock price compliance from the NYSE American

Financial Results

Our consolidated balance sheets, statements of operations, and statements of stockholders’ equity have been restated, as required, for all periods presented to reflect the reverse stock split as if it had occurred on January 1, 2018. Our consolidated statements of cash flows were not impacted by the reverse stock split.

  • Total revenues for the first quarter of 2019 were $136,000, compared to $276,000 in the same period of 2018. The decrease was primarily due to a reduction in grant revenue related to SBIR grants from the NIH supporting Manocept development, offset by sublicense revenue related to the adoption of new lease accounting standards effective January 1, 2019.
  • Research and development (“R&D”) expenses for the first quarter of 2019 were $741,000, compared to $999,000 in the same period of 2018. The decrease was primarily due to net decreases in drug project expenses including therapeutics and Tc99m tilmanocept development costs, coupled with decreased compensation costs resulting from net decreased salaries and headcount.
  • Selling, general and administrative (“SG&A”) expenses were approximately $1.8 million in each of the first quarters of 2019 and 2018. Increased legal and professional services and increased lease expenses due to the new lease accounting standards which were effective January 1, 2019 were offset by decreased compensation and decreased investor relations costs.
  • Navidea’s net loss attributable to common stockholders for the first quarter of 2019 was $2.4 million, or $0.24 per share, compared to a net loss attributable to common stockholders of $6.7 million, or $0.83 per share, for the same period in 2018.
  • Navidea ended the first quarter of 2019 with $2.1 million in cash and investments.

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