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 ended March 31, 2020.
"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."
First Quarter 2020 Highlights and Subsequent Events
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."
Financial Results
Navidea's consolidated balance sheets, statements of operations, and statements of stockholders' equity have been restated, as required, for all periods presented to reflect the April 2019 reverse stock split as if it had occurred on January 1, 2018. The consolidated statements of cash flows were not impacted by the reverse stock split.
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. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.
Event: |
Q1 2020 Earnings and Business Update Conference Call |
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Date: |
Thursday, May 14, 2020 |
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Time: |
5:00 p.m. (EDT) |
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U.S. & Canada Dial-in: |
877-407-0312 |
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International Dial-in: |
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+1 201-389-0899 |
Conference ID: |
13703112 |
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Webcast Link: |
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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.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocepttm platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea's strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company's pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
NAVIDEA BIOPHARMACEUTICALS, INC. | |||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
March 31, | December 31, | ||||||||||
2020 |
|
2019 |
|
||||||||
(unaudited) | |||||||||||
Assets: | |||||||||||
Cash and cash equivalents | $ |
601,355 |
|
$ |
1,047,159 |
|
|||||
Other current assets |
|
2,845,404 |
|
|
1,868,624 |
|
|||||
Non-current assets |
|
1,030,472 |
|
|
1,235,123 |
|
|||||
Total assets | $ |
4,477,231 |
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$ |
4,150,906 |
|
|||||
Liabilities and stockholders' deficit: | |||||||||||
Current liabilities | $ |
4,354,569 |
|
$ |
3,819,551 |
|
|||||
Deferred revenue, non-current |
|
700,000 |
|
|
700,000 |
|
|||||
Other liabilities |
|
513,701 |
|
|
512,344 |
|
|||||
Total liabilities |
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5,568,270 |
|
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5,031,895 |
|
|||||
Navidea stockholders' deficit |
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(1,822,344 |
) |
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(1,612,292 |
) |
|||||
Noncontrolling interest |
|
731,305 |
|
|
731,303 |
|
|||||
Total stockholders' deficit |
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(1,091,039 |
) |
|
(880,989 |
) |
|||||
Total liabilities and stockholders' deficit | $ |
4,477,231 |
|
$ |
4,150,906 |
|
|||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
Three Months Ended | |||||||||||
March 31, | March 31, | ||||||||||
2020 |
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2019 |
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||||||||
(unaudited) |
(unaudited) |
||||||||||
Revenue: | |||||||||||
Royalty revenue | $ |
15,221 |
|
$ |
3,150 |
|
|||||
Grant and other revenue |
|
141,051 |
|
|
38,474 |
|
|||||
Total revenue |
|
156,272 |
|
|
41,624 |
|
|||||
Cost of revenue |
|
609 |
|
|
6,126 |
|
|||||
Gross profit |
|
155,663 |
|
|
35,498 |
|
|||||
Operating expenses: | |||||||||||
Research and development |
|
999,269 |
|
|
740,583 |
|
|||||
Selling, general and administrative |
|
1,827,754 |
|
|
1,728,516 |
|
|||||
Total operating expenses |
|
2,827,023 |
|
|
2,469,099 |
|
|||||
Loss from operations |
|
(2,671,360 |
) |
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(2,433,601 |
) |
|||||
Other income (expense): | |||||||||||
Interest (expense) income, net |
|
(2,372 |
) |
|
9,848 |
|
|||||
Other, net |
|
124 |
|
|
(1,135 |
) |
|||||
Loss before income taxes |
|
(2,673,608 |
) |
|
(2,424,888 |
) |
|||||
Provision for income taxes |
|
- |
|
|
(876 |
) |
|||||
Net loss from continuing operations |
|
(2,673,608 |
) |
|
(2,425,764 |
) |
|||||
Loss from discontinued operations, net of tax effect |
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- |
|
|
(3,297 |
) |
|||||
Net loss |
|
(2,673,608 |
) |
|
(2,429,061 |
) |
|||||
Income (loss) attributable to noncontrolling interest |
|
2 |
|
|
(12 |
) |
|||||
Net loss attributable to common stockholders | $ |
(2,673,610 |
) |
$ |
(2,429,049 |
) |
|||||
Loss per common share (basic and diluted): | |||||||||||
Continuing operations | $ |
(0.13 |
) |
$ |
(0.24 |
) |
|||||
Attributable to common stockholders | $ |
(0.13 |
) |
$ |
(0.24 |
) |
|||||
Weighted average shares outstanding |
|
20,203,636 |
|
|
10,017,848 |
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