Navidea Biopharma (NAVB) Reports Q1 Loss of $0.13
Navidea Biopharma (NYSE: NAVB) reported Q1 EPS of ($0.13), versus ($0.24) reported last year. Revenue for the quarter came in at $155.66 thousand, versus $41.62 thousand reported last year.
First Quarter 2020 Highlights and Subsequent Events
- Continued with double-digit subject enrollment in the Company’s NAV3-31 Phase 2b study in rheumatoid arthritis (“RA”) and completed enrollment of subjects in Arms 1 and 2.
- Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
- Announced extension by the U.S. Patent and Trademark Office of U.S. patent 6,409,990 pertaining to Lymphoseek® for an additional five years through May 12, 2025.
- Converted two provisional patents, one pertaining to image analysis relevant to the RA program and the other to the therapeutic space, to A1 applications.
- Signed a letter of intent to partner with WorldCare Clinical, LLC for the Company’s RA diagnostic clinical imaging workflow.
- Regained the commercialization and distribution rights for Lymphoseek® (Tc99m tilmanocept) injection in Europe through the mutually agreed upon termination of the perpetual license agreement with SpePharm AG, a subsidiary of Norgine B.V.
- Executed agreements with two existing investors to purchase approximately 4.0 million shares of the Company’s common stock for aggregate gross proceeds to Navidea of approximately $3.4 million.
- Finalized the previously announced $4.2 million financing related to the judgment by the Ohio Court of Common Pleas (the “Judgment”). Navidea has agreed to issue Keystone Capital Partners, LLC, an existing shareholder, up to $4.2 million of convertible preferred shares, which will be guaranteed by a portion of the proceeds of the Judgment.
- Following execution of the funding transactions described above, the Company regained compliance with the NYSE American’s continued listing standards with stockholders’ equity of $6.0 million.
“During the first quarter, despite the pandemic and the Work-From-Home quarantine procedures, Navidea has maintained strong business operations. Enrollment in the Company’s clinical trials are ongoing and we have enough patients in our NAV3-31 trial to evaluate for the upcoming interim analysis. More importantly, the Company continued its dialogue with several key potential partners and we anticipate providing updates on those initiatives imminently,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “Regaining the rights to Lymphoseek in Europe, New Zealand and Australia is a watershed moment for this management team and we are excited about the potential for this asset in Europe based on its successful and broad-based commercial adoption in the United States.”
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, “The clinical research team has been working diligently to continue to advance the technology in key disease areas, with an emphasis on our ongoing RA trials. We are currently analyzing the data from the NAV3-31 Phase 2B trial in RA for our second interim analysis. We also continue to prepare for the start of our second Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients as well as the Phase 3 trial.”
For earnings history and earnings-related data on Navidea Biopharma (NAVB) click here.
