08/15/2022 | Press release | Distributed by Public on 08/15/2022 06:38
Conference Call to be Scheduled at a Later Date
DUBLIN, Ohio--(BUSINESS WIRE)-- 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 second quarter and year-to-date for the period ended June 30, 2022.
Second Quarter 2022 Highlights and Subsequent Events
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 the clinic."
Financial Results
The Company's registration statement on Form S-1 (Registration No. 333-262691) relative to the Company's current rights offering was declared effective by the Securities and Exchange Commission ("SEC") on August 3, 2022. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC's web site at http://www.sec.gov. Copies of the final prospectus for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
In light of the Company's pending rights offering, the Company will host a second quarter earnings conference call and business update following the conclusion of the rights offering. The Company will issue a press release announcing the date and time of the earnings conference call.
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 Manocept 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 | ||||||||||||
June 30, |
December 31, |
|||||||||||
2022 |
2021 |
|||||||||||
(unaudited) | ||||||||||||
Assets: | ||||||||||||
Cash and cash equivalents |
$ |
328,012 |
$ |
4,230,865 |
||||||||
Other current assets |
842,728 |
1,152,420 |
||||||||||
Non-current assets |
1,332,965 |
1,261,548 |
||||||||||
Total assets |
$ |
2,503,705 |
$ |
6,644,833 |
||||||||
Liabilities and stockholders' (deficit) equity: | ||||||||||||
Current liabilities |
$ |
5,321,985 |
$ |
5,299,802 |
||||||||
Deferred revenue, non-current |
700,000 |
700,000 |
||||||||||
Note payable to related party, net of discount |
720,305 |
- |
||||||||||
Other liabilities |
2,062 |
20,288 |
||||||||||
Total liabilities |
6,744,352 |
6,020,090 |
||||||||||
Total stockholders' deficit |
(4,533,164 |
) |
(106,556 |
) |
||||||||
Noncontrolling interest |
292,517 |
731,299 |
||||||||||
Total Navidea stockholders' (deficit) equity |
(4,240,647 |
) |
624,743 |
|||||||||
Total liabilities and stockholders' (deficit) equity |
$ |
2,503,705 |
$ |
6,644,833 |
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||
June 30, |
June 30, |
June 30, |
June 30, |
|||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
|||||||||
Revenue |
$ |
57,526 |
$ |
261,046 |
$ |
57,526 |
$ |
384,783 |
||||
Cost of revenue |
473 |
- |
473 |
- |
||||||||
Gross profit |
57,053 |
261,046 |
57,053 |
384,783 |
||||||||
Operating expenses: | ||||||||||||
Research and development |
1,723,988 |
1,498,056 |
2,893,242 |
2,720,810 |
||||||||
Selling, general and administrative |
1,255,666 |
1,432,610 |
3,065,695 |
3,663,355 |
||||||||
Total operating expenses |
2,979,654 |
2,930,666 |
5,958,937 |
6,384,165 |
||||||||
Loss from operations |
(2,922,601 |
) |
(2,669,620 |
) |
(5,901,884 |
) |
(5,999,382 |
) |
||||
Other income (expense): | ||||||||||||
Interest (expense) income, net |
(83,584 |
) |
1,266 |
(87,246 |
) |
(1,609 |
) |
|||||
Gain on extinguishment of debt |
- |
- |
- |
366,000 |
||||||||
Other, net |
6,726 |
(5,686 |
) |
2,427 |
(5,941 |
) |
||||||
Net loss |
(2,999,459 |
) |
(2,674,040 |
) |
(5,986,703 |
) |
(5,640,932 |
) |
||||
Loss attributable to noncontrolling interest |
1 |
1 |
3 |
3 |
||||||||
Net loss attributable to common stockholders |
$ |
(2,999,458 |
) |
$ |
(2,674,039 |
) |
$ |
(5,986,700 |
) |
$ |
(5,640,929 |
) |
Loss attributable to common stockholders | ||||||||||||
per common share (basic and diluted) |
$ |
(0.10 |
) |
$ |
(0.09 |
) |
$ |
(0.20 |
) |
$ |
(0.20 |
) |
Weighted average shares outstanding (basic and diluted) |
30,268,858 |
29,117,832 |
30,238,471 |
28,531,660 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20220814005023/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
[email protected]
Source: Navidea Biopharmaceuticals, Inc.
Released August 15, 2022