CORRECTING and REPLACING Navidea Biopharmaceuticals Reports Fourth Quarter 2021 Financial Results
Conference Call to be held
The updated release reads:
NAVIDEA BIOPHARMACEUTICALS REPORTS FOURTH QUARTER 2021 FINANCIAL RESULTS
Conference Call to be held
Fourth Quarter 2021 Highlights and Subsequent Events
- Continued to work on financing for the Company. We have engaged with an investment bank and options are being pursued.
- Initiated and enrolled 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.”
- Continued enrollment into the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Eleven patients out of an originally estimated maximum of 24 based on subject pathotype are now enrolled with both imaging and biopsy performed.
- Completed enrollment in the Company’s NAV3-35 Phase 2b study, “Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept.”
-
Completed the investigator-initiated Phase 2 trial being run at the
Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals. An abstract was presented at the Conference on Retroviruses and Opportunistic Infections inFebruary 2022 . -
Signed research agreement with the
University of Pennsylvania evaluating Tc99m tilmanocept as a prognostic marker for glioblastoma. -
Signed a Letter of Intent with the image analysis company
MIM Software, Inc. , to be the Company’s commercial partner for image quantification of Tc99m tilmanocept imaging in RA. - Filed two new provisional patent applications. The first is related to new methods of attaching chemotherapeutics to the Manocept platform, and the second relates to maximizing target-tissue uptake and off-target competitive blocking. These have important implications for pipeline applications.
Financial Results
-
Total net revenues for the fourth quarter of 2021 were
, compared to$50,000 for the same period in 2020. Total net revenues for the full year of 2021 were$219,000 , compared to$532,000 in 2020. The decrease was primarily due to decreased grant revenue related to$914,000 Small Business Innovation Research grants from theNational Institutes of Health supporting Manocept™ development and decreased royalty and license revenue from sales of Tc99m tilmanocept inEurope , offset by the partial recovery of debts previously written off in 2015 and receipt of reimbursement fromCardinal Health 414, LLC of certain R&D costs. -
Research and development (“R&D”) expenses for the fourth quarter of 2021 were
, compared to$1.4 million in the same period in 2020. R&D expenses for the full year of 2021 were$1.3 million , compared to$5.1 million in 2020. The net increase during the year to date was primarily due to increased regulatory consulting, employee compensation, travel, recruiting and general office expenses, coupled with net increases in drug project expenses, including increased Manocept therapeutic and Tc99m tilmanocept development costs, offset by decreased Manocept diagnostic development costs.$4.9 million -
Selling, general and administrative (“SG&A”) expenses for the fourth quarter of 2021 were
, compared to$2.3 million in the same period in 2020. SG&A expenses for the full year of 2021 were$1.7 million , compared to$7.5 million in 2020. The net increase during the year to date was primarily due to separation expenses related to the resignation of our former Chief Executive Officer, coupled with increased consulting services related to European distribution of Tc99m tilmanocept, director compensation related to additional board members and increased board compensation rates, insurance costs, losses on the abandonment of certain intellectual property, recruiting fees, travel and general office expenses, offset by decreases in legal and professional services, employee compensation, investor relations costs, European annual registration fees, facilities costs and franchise taxes.$6.7 million -
Navidea’s net loss attributable to common stockholders for the fourth quarter of 2021 was
, or$3.7 million per share, compared to$0.12 , or$3.0 million per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the full year of 2021 was$0.11 , or$11.7 million per share, compared to$0.40 , or$11.4 million per share, in 2020.$0.48 -
Navidea ended the fourth quarter of 2021 with
in cash and cash equivalents.$4.2 million
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.
To participate in the call and webcast, please refer to the information below:
Event: Fourth Quarter 2021 Earnings Conference Call and Business Update
Date:
Time:
International Dial-In: +1 201-389-0899
Conference ID: 13726541
Webcast Link: https://www.webcast-eqs.com/navidbioph20220323/en
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
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
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.
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||||||
2021 |
2020 |
||||||||||||||
(unaudited) | |||||||||||||||
Assets: | |||||||||||||||
Cash and cash equivalents | $ |
4,230,865 |
|
$ |
2,670,495 |
|
|||||||||
Other current assets |
|
1,152,420 |
|
|
3,857,833 |
|
|||||||||
Non-current assets |
|
1,261,548 |
|
|
1,229,690 |
|
|||||||||
Total assets | $ |
6,644,833 |
|
$ |
7,758,018 |
|
|||||||||
Liabilities and stockholders' equity: | |||||||||||||||
Current liabilities | $ |
5,299,802 |
|
$ |
4,715,105 |
|
|||||||||
Deferred revenue, non-current |
|
700,000 |
|
|
700,000 |
|
|||||||||
Other liabilities |
|
20,288 |
|
|
296,006 |
|
|||||||||
Total liabilities |
|
6,020,090 |
|
|
5,711,111 |
|
|||||||||
Navidea stockholders' (deficit) equity |
|
(106,556 |
) |
|
1,315,604 |
|
|||||||||
Noncontrolling interest |
|
731,299 |
|
|
731,303 |
|
|||||||||
Total stockholders' equity |
|
624,743 |
|
|
2,046,907 |
|
|||||||||
Total liabilities and stockholders' equity | $ |
6,644,833 |
|
$ |
7,758,018 |
|
|||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||||||
(unaudited) | (unaudited) | (unaudited) | |||||||||||||
Revenue | $ |
50,348 |
|
$ |
219,251 |
|
$ |
531,513 |
|
$ |
915,013 |
|
|||
Cost of revenue |
|
- |
|
|
- |
|
|
- |
|
|
1,048 |
|
|||
Gross profit |
|
50,348 |
|
|
219,251 |
|
|
531,513 |
|
|
913,965 |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
1,372,314 |
|
|
1,271,141 |
|
|
5,141,910 |
|
|
4,930,187 |
|
|||
Selling, general and administrative |
|
2,317,285 |
|
|
1,748,680 |
|
|
7,450,015 |
|
|
6,694,959 |
|
|||
Total operating expenses |
|
3,689,599 |
|
|
3,019,821 |
|
|
12,591,925 |
|
|
11,625,146 |
|
|||
Loss from operations |
|
(3,639,251 |
) |
|
(2,800,570 |
) |
|
(12,060,412 |
) |
|
(10,711,181 |
) |
|||
Other income (expense): | |||||||||||||||
Interest income (expense), net |
|
(1,938 |
) |
|
(1,478 |
) |
|
(6,361 |
) |
|
11,344 |
|
|||
Gain on extinguishment of debt |
|
- |
|
|
- |
|
|
366,000 |
|
|
- |
|
|||
Other, net |
|
(10,974 |
) |
|
(21,077 |
) |
|
(14,115 |
) |
|
(21,854 |
) |
|||
Loss before income taxes |
|
(3,652,163 |
) |
|
(2,823,125 |
) |
|
(11,714,888 |
) |
|
(10,721,691 |
) |
|||
Provision for income taxes |
|
- |
|
|
- |
|
|
(16,043 |
) |
|
- |
|
|||
Net loss |
|
(3,652,163 |
) |
|
(2,823,125 |
) |
|
(11,730,931 |
) |
|
(10,721,691 |
) |
|||
Loss attributable to noncontrolling interest |
|
- |
|
|
1 |
|
|
4 |
|
|
- |
|
|||
Deemed dividend on Series C and Series D | |||||||||||||||
preferred stock beneficial conversion feature |
|
- |
|
|
(180,556 |
) |
|
- |
|
|
(663,889 |
) |
|||
Net loss attributable to common stockholders | $ |
(3,652,163 |
) |
$ |
(3,003,680 |
) |
$ |
(11,730,927 |
) |
$ |
(11,385,580 |
) |
|||
Loss attributable to common stockholders | |||||||||||||||
per common shares (basic and diluted) | $ |
(0.12 |
) |
$ |
(0.11 |
) |
$ |
(0.40 |
) |
$ |
(0.48 |
) |
|||
Weighted average shares outstanding (basic and diluted) |
|
30,161,825 |
|
|
26,724,753 |
|
|
29,343,542 |
|
|
23,896,001 |
|
|||
View source version on businesswire.com: https://www.businesswire.com/news/home/20220323005340/en/
Investor Relations Contact
Vice President of Operations
614-822-2365
jsmith@navidea.com
Source: