Navidea Biopharmaceuticals Reports Third Quarter 2022 Financial Results
Navidea Biopharmaceuticals (NAVB) reported its financial results for Q3 and the first nine months of 2022, revealing total revenues of $8,000 for Q3 and $65,000 year-to-date, down from $96,000 and $481,000 in 2021, respectively. The company recorded a net loss of $7.7 million for Q3, compared to $2.4 million in the same 2021 period. Despite these challenges, Navidea is actively enrolling patients in its NAV3-33 Phase 3 clinical trial for rheumatoid arthritis and presented encouraging preliminary results from the NAV3-32 Phase 2B trial.
- Enrollment continues in NAV3-33 Phase 3 trial, expanding to 12 sites.
- Positive preliminary results from NAV3-32 Phase 2B trial.
- Received $6.2 million from Rights Offering.
- Positive results from preclinical studies in targeted cancer immunotherapy.
- Total revenues significantly decreased: Q3 2022 $8,000 vs. $96,000 in Q3 2021.
- Net loss for Q3 2022 increased to $7.7 million, up from $2.4 million in Q3 2021.
- R&D expenses rose to $1.2 million in Q3 2022, compared to $1.0 million in Q3 2021.
- SG&A expenses surged to $3.6 million in Q3 2022, up from $1.5 million in Q3 2021.
Conference Call to be held
Third Quarter 2022 Highlights and Subsequent Events
- Continued enrollment 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.”
- Announced the opening of nine additional sites for recruitment into the Company’s pivotal NAV3-33 Phase 3 clinical trial, for a total of 12 sites now open and recruiting.
-
Presented positive results from the Company’s completed NAV3-31 Phase 2B clinical study as well as the positive preliminary results of its ongoing NAV3-32 Phase 2B study at the Annual Meeting of the
American College of Rheumatology heldNovember 10-14, 2022 inPhiladelphia, PA. -
Presented results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform at the 37th Annual Meeting of the
Society for Immunotherapy of Cancer heldNovember 8-12, 2022 inBoston, MA. Results demonstrate efficacy of new constructs at macrophage phenotype change and in a mouse tumor model. -
Received gross cash proceeds of
in connection with the Rights Offering.$6.2 million -
Received
from a strategic partner as reimbursement for certain manufacturing and research and development expenses.$800,000 -
Received an additional
under a bridge loan from the Company’s Vice Chair of the Board of Directors,$1.5 million John K. Scott , Jr. -
Appointed
Joshua M. Wilson , a seasoned banking and finance executive with more than 23 years of financial services and family office experience, to the Company’s Board of Directors. -
Received notification of issuance of patent from the USPTO and the state of
Israel for the application titled, “Compounds And Compositions For Treating Leishmaniasis And Methods Of Diagnosis And Treating Using Same” (Patent No. US 11,369,680 B2; State of Israel Patent Office No. 265830). - Filed a provisional patent application describing a new degradable linker for dexamethasone and paclitaxel containing Manocept therapeutic constructs. These constructs are being evaluated preclinically for effects on macrophages and in animal models of oncology and inflammatory indications.
-
Announced publication of a manuscript titled “Increased Macrophage Specific Arterial Inflammation Relates Uniquely to Non-calcified Plaque and Specific Immune Activation Pathways in People with HIV: A Targeted Molecular Imaging Approach,” based on work performed at the
Massachusetts General Hospital (“MGH”) andHarvard Medical School ,Boston MA , and sponsored by the Company. The research, appearing inThe Journal of Infectious Diseases (PMID: 35856671), was led by Principal InvestigatorSteven Grinspoon , MD, Chief of the Metabolism Unit at MGH and Professor of Medicine atHarvard Medical School . -
Announced publication of a manuscript titled “Tilmanocept as a novel tracer for lymphatic mapping and sentinel lymph node biopsy in melanoma and oral cancer,” based on work performed at the
Crown Princess Mary Cancer Centre (“CPMCC”) at theUniversity of Sydney , inSydney, Australia . The research, appearing in theANZ Journal of Surgery (PMID: 35848587), was led by Principal Investigator Dr. Muzib Abdul-Razak, MBBS, FRACS, FRCSE, MCh., of the Faculty of Medicine,Department of Surgical Oncology and Head and Neck Surgery in the CPMCC at theUniversity of Sydney .
Financial Results
-
Total revenues for the three-month period ended
September 30, 2022 were approximately , compared to$8,000 for the same period in 2021. Total revenues for the nine-month period ended$96,000 September 30, 2022 were , compared to$65,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debts previously written off in 2015, the 2021 receipt of reimbursement from$481,000 Cardinal Health 414, LLC of certain research and development (“R&D”) costs, decreased grant revenue related toSmall Business Innovation Research grants from theNational Institutes of Health supporting Manocept development, and decreased license revenue from transitional sales of Tc99m tilmanocept inEurope . -
Research and development expenses for the three-month period ended
September 30, 2022 were , compared to$1.2 million for the same period in 2021. R&D expenses for the nine-month period ended$1.0 million September 30, 2022 were , compared to$4.1 million for the same period in 2021. The increase was primarily due to increased employee compensation including incentive-based awards offset by decreases in drug project expenses and regulatory consulting expenses.$3.8 million -
Selling, general and administrative (“SG&A”) expenses for the three-month period ended
September 30, 2022 were , compared to$3.6 million for the same period in 2021. SG&A expenses for the nine-month period ended$1.5 million September 30, 2022 were , compared to$6.7 million for the same period in 2021. Following the ruling by the$5.1 million Texas Court inAugust 2022 , the Company recorded in legal fees in SG&A pursuant to the CRG judgment. Increases in legal and professional services, insurance, director fees, losses on the abandonment of certain intellectual property, and depreciation and amortization were partially offset by decreases in employee compensation including fringe benefits and incentive-based awards, expenses related to European operations, investor relations and shareholder services, travel, facilities costs, general office expenses and franchise taxes.$2.6 million -
Navidea’s net loss attributable to common stockholders for the three-month period ended
September 30, 2022 was , or$7.7 million per share, compared to$0.25 , or$2.4 million per share, for the same period in 2021. Navidea’s net loss attributable to common stockholders for the nine-month period ended$0.08 September 30, 2022 was , or$13.7 million per share, compared to$0.45 , or$8.1 million per share, for the same period in 2021.$0.28 -
Navidea ended the third quarter of 2022 with
in cash and cash equivalents.$4.6 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: Third Quarter 2022 Earnings Conference Call and Business Update
Date:
Time:
International Dial-In: +1 201-389-0899
Webcast Link: https://www.webcast-eqs.com/navidbioph20221115/en
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 | ||||||||||||||||
|
|
|
||||||||||||||
2022 |
|
2021 |
||||||||||||||
(unaudited) | ||||||||||||||||
Assets: | ||||||||||||||||
Cash and cash equivalents | $ |
4,600,791 |
|
$ |
4,230,865 |
|
||||||||||
Other current assets |
|
499,120 |
|
|
1,152,420 |
|
||||||||||
Non-current assets |
|
1,158,521 |
|
|
1,261,548 |
|
||||||||||
Total assets | $ |
6,258,432 |
|
$ |
6,644,833 |
|
||||||||||
Liabilities and stockholders' (deficit) equity: | ||||||||||||||||
Current liabilities | $ |
8,432,857 |
|
$ |
5,299,802 |
|
||||||||||
Deferred revenue, non-current |
|
700,000 |
|
|
700,000 |
|
||||||||||
Note payable to related party, net of discount |
|
1,791,001 |
|
|
- |
|
||||||||||
Other liabilities |
|
1,690 |
|
|
20,288 |
|
||||||||||
Total liabilities |
|
10,925,548 |
|
|
6,020,090 |
|
||||||||||
Total stockholders' deficit |
|
(4,959,633 |
) |
|
(106,556 |
) |
||||||||||
Noncontrolling interest |
|
292,517 |
|
|
731,299 |
|
||||||||||
Navidea stockholders' (deficit) equity |
|
(4,667,116 |
) |
|
624,743 |
|
||||||||||
Total liabilities and stockholders' (deficit) equity | $ |
6,258,432 |
|
$ |
6,644,833 |
|
||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
Three Months Ended |
|
Nine Months Ended |
||||||||||||||
|
|
|
|
|
|
|
||||||||||
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
Revenue | $ |
7,516 |
|
$ |
96,382 |
|
$ |
65,042 |
|
$ |
481,165 |
|
||||
Cost of revenue |
|
134,438 |
|
|
- |
|
|
134,911 |
|
|
- |
|
||||
Gross (loss) profit |
|
(126,922 |
) |
|
96,382 |
|
|
(69,869 |
) |
|
481,165 |
|
||||
Operating expenses: | ||||||||||||||||
Research and development |
|
1,186,419 |
|
|
1,048,786 |
|
|
4,079,661 |
|
|
3,769,596 |
|
||||
Selling, general and administrative |
|
3,637,450 |
|
|
1,469,375 |
|
|
6,703,145 |
|
|
5,132,730 |
|
||||
Total operating expenses |
|
4,823,869 |
|
|
2,518,161 |
|
|
10,782,806 |
|
|
8,902,326 |
|
||||
Loss from operations |
|
(4,950,791 |
) |
|
(2,421,779 |
) |
|
(10,852,675 |
) |
|
(8,421,161 |
) |
||||
Other income (expense): | ||||||||||||||||
Interest income (expense), net |
|
(765,456 |
) |
|
(2,814 |
) |
|
(852,702 |
) |
|
(4,423 |
) |
||||
Gain on extinguishment of debt |
|
- |
|
|
- |
|
|
- |
|
|
366,000 |
|
||||
Other, net |
|
8,422 |
|
|
2,800 |
|
|
10,849 |
|
|
(3,141 |
) |
||||
Loss before income taxes |
|
(5,707,825 |
) |
|
(2,421,793 |
) |
|
(11,694,528 |
) |
|
(8,062,725 |
) |
||||
Provision for income taxes |
|
- |
|
|
(16,043 |
) |
|
- |
|
|
(16,043 |
) |
||||
Net loss |
|
(5,707,825 |
) |
|
(2,437,836 |
) |
|
(11,694,528 |
) |
|
(8,078,768 |
) |
||||
Net loss attributable to noncontrolling interest |
|
- |
|
|
1 |
|
|
4 |
|
|
4 |
|
||||
Net loss attributable to Navidea and subsidiaries |
|
(5,707,825 |
) |
|
(2,437,835 |
) |
|
(11,694,524 |
) |
|
(8,078,764 |
) |
||||
Deemed dividend on preferred stock exchanged for Units |
|
(2,037,886 |
) |
|
- |
|
|
(2,037,886 |
) |
|
- |
|
||||
Net loss attributable to common stockholders | $ |
(7,745,711 |
) |
$ |
(2,437,835 |
) |
$ |
(13,732,410 |
) |
$ |
(8,078,764 |
) |
||||
Loss attributable to common stockholders per common share (basic and diluted) | $ | (0.25 |
) | $ | (0.08 |
) | $ | (0.45 |
) | $ | (0.28 |
) | ||||
Weighted average shares outstanding (basic and diluted) |
|
30,732,001 |
|
|
30,122,549 |
|
|
30,404,789 |
|
|
29,067,784 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20221114005449/en/
Vice President of Operations
614-822-2365
jsmith@navidea.com
Source:
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