Navidea Biopharmaceuticals Reports Fourth Quarter 2022 Financial Results
Navidea Biopharmaceuticals (NYSE American: NAVB) announced its financial results for Q4 and full year 2022. Total revenues for Q4 were approximately $1,000, a decrease from $50,000 in Q4 2021, and $66,000 for the year, down from $532,000 in 2021. R&D expenses increased to $1.9 million in Q4 from $1.4 million and total expenses for the year were $6.0 million. Navidea reported a net loss of $3.5 million or $0.11 per share for Q4 and $17.2 million or $0.56 per share for 2022. The company continues to enroll participants in its NAV3-33 Phase 3 trial for rheumatoid arthritis and has received several patent approvals, enhancing its immunodiagnostic and immunotherapeutic initiatives.
- Continued enrollment in NAV3-33 Phase 3 trial for rheumatoid arthritis, indicating ongoing clinical development.
- Positive results presented from NAV3-31 and preliminary NAV3-32 Phase 2B studies at major medical conferences.
- Issuance of multiple U.S. patents supporting the Manocept platform, enhancing intellectual property portfolio.
- Significant revenue decline from $532,000 in 2021 to $66,000 in 2022, primarily due to the loss of previous R&D reimbursements.
- Increased net loss from $11.7 million in 2021 to $17.2 million in 2022, reflecting ongoing financial challenges.
- R&D expenses increased, potentially indicating higher operational costs without corresponding revenue growth.
Conference Call to be held
Fourth Quarter 2022 Highlights and Subsequent Events
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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.” The Company announced enrollment of the 50th participant in NAV3-33 in
November 2022 . -
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 notification of issuance of
U.S. Patent No. 11,590,236 from the United States Patent and Trademark Office for the Company’s application titled, “Compositions And Methods For Altering Macrophage Phenotype.” This patent covers the ability of the Company’s constructs to stimulate an immune response against tumors through targeted delivery of payloads that change the nature of macrophages to make them more proinflammatory. Efficacy of these constructs has been demonstrated in preclinical studies. -
Received notifications of issuance for Company patent applications in the state of
Israel for the application titled, “Compounds And Compositions For Treating Leishmaniasis And Methods Of Diagnosis And Treating Using Same” (State of Israel Patent No. 265830;U.S. counterpart application issued inJune 2022 asU.S. Patent No. 11,369,680) and inCanada for Canadian Patent No. 2,955,441 titled, “Compositions, Methods, and Kits for Diagnosing and Treating CD206 Expressing Cell-Related Disorders.” (U.S. counterpart application issued inOctober 2020 asU.S. Patent No. 10,806,803.) - Filed a provisional patent application describing a different chemical linker used in a critical step in the Manocept synthesis process, one which is more stable and easier to manufacture than the current linker that is used. This could have significant implications for both diagnostic and therapeutic applications.
-
Converted several provisional patent applications to reviewable patent applications in the
U.S. and Patent Cooperation Treaty countries. -
The Company’s work performed in collaboration with investigators from the
University of Alabama at Birmingham and titled, “In vivo Assessment of the Impact of Molecular Weight on Constructs of 68Ga-DOTA-Manocept in a Syngeneic Mouse Tumor Model” was published in the journal Molecular Imaging and Biology (2023Mar. 7 . Online ahead of print.).
Financial Results
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Total revenues for the three-month period ended
December 31, 2022 were approximately , compared to$1,000 for the same period in 2021. Total revenues for the year ended$50,000 December 31, 2022 were , compared to$66,000 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$532,000 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
December 31, 2022 were , compared to$1.9 million for the same period in 2021. R&D expenses for the year ended$1.4 million December 31, 2022 were , compared to$6.0 million for the same period in 2021. The year-over-year increase was primarily due to increased drug project expenses and increased employee compensation including incentive-based awards, offset by decreased regulatory consulting expenses.$5.1 million -
Selling, general and administrative (“SG&A”) expenses for the three-month period ended
December 31, 2022 were , compared to$1.3 million for the same period in 2021. SG&A expenses for the year ended$2.3 million December 31, 2022 were , compared to$8.0 million for the same period in 2021. Following the ruling by the$7.5 million Texas Court inAugust 2022 , the Company recorded of legal fees in SG&A pursuant to the CRG judgment. The year-over-year increase was also due to increases in insurance and depreciation and amortization, partially offset by decreases in employee compensation including fringe benefits and incentive-based awards, expenses related to European operations, travel, legal and professional services, investor relations and shareholder services, general office expenses, facilities costs, losses on the abandonment of certain intellectual property and franchise taxes.$2.6 million -
Navidea’s net loss attributable to common stockholders for the three-month period ended
December 31, 2022 was , or$3.5 million per share, compared to$0.11 , or$3.7 million per share, for the same period in 2021. Navidea’s net loss attributable to common stockholders for the year ended$0.12 December 31, 2022 was , or$17.2 million per share, compared to$0.56 , or$11.7 million per share, for the same period in 2021.$0.40 -
Navidea ended the fourth quarter of 2022 with approximately
in cash and cash equivalents.$2.0 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 2022 Earnings Conference Call and Business Update
Date:
Time:
International Dial-In: +1 201-389-0899
Conference ID: 13736745
Webcast Link: https://www.webcast-eqs.com/navidbioph20230321/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 | |||||||||||||||
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|||||||||||||
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2022 |
|
|
|
2021 |
|
|||||||||
(unaudited) |
|
|
|||||||||||||
Assets: | |||||||||||||||
Cash and cash equivalents | $ |
1,995,860 |
|
$ |
4,230,865 |
|
|||||||||
Other current assets |
|
1,208,084 |
|
|
1,152,420 |
|
|||||||||
Non-current assets |
|
1,167,662 |
|
|
1,261,548 |
|
|||||||||
Total assets | $ |
4,371,606 |
|
$ |
6,644,833 |
|
|||||||||
Liabilities and stockholders' equity: | |||||||||||||||
Current liabilities | $ |
9,941,889 |
|
$ |
5,299,802 |
|
|||||||||
Note payable to related party, net of discount |
|
1,871,715 |
|
|
- |
|
|||||||||
Deferred revenue, non-current |
|
700,000 |
|
|
700,000 |
|
|||||||||
Other liabilities |
|
1,312 |
|
|
20,288 |
|
|||||||||
Total liabilities |
|
12,514,916 |
|
|
6,020,090 |
|
|||||||||
Navidea stockholders' (deficit) equity |
|
(8,435,828 |
) |
|
(106,556 |
) |
|||||||||
Noncontrolling interest |
|
292,518 |
|
|
731,299 |
|
|||||||||
Total stockholders' equity |
|
(8,143,310 |
) |
|
624,743 |
|
|||||||||
Total liabilities and stockholders' equity | $ |
4,371,606 |
|
$ |
6,644,833 |
|
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
Three Months Ended |
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Twelve Months Ended |
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2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
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Revenue | $ |
610 |
|
$ |
50,348 |
|
$ |
65,652 |
|
$ |
531,513 |
|
|||
Cost of revenue |
|
50,036 |
|
|
- |
|
|
184,947 |
|
|
- |
|
|||
Gross (loss) profit |
|
(49,426 |
) |
|
50,348 |
|
|
(119,295 |
) |
|
531,513 |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
1,890,113 |
|
|
1,372,314 |
|
|
5,969,774 |
|
|
5,141,910 |
|
|||
Selling, general and administrative |
|
1,258,681 |
|
|
2,317,285 |
|
|
7,961,826 |
|
|
7,450,015 |
|
|||
Total operating expenses |
|
3,148,794 |
|
|
3,689,599 |
|
|
13,931,600 |
|
|
12,591,925 |
|
|||
Loss from operations |
|
(3,198,220 |
) |
|
(3,639,251 |
) |
|
(14,050,895 |
) |
|
(12,060,412 |
) |
|||
Other (expense) income: | |||||||||||||||
Interest (expense) income, net |
|
(245,620 |
) |
|
(1,938 |
) |
|
(1,098,322 |
) |
|
(6,361 |
) |
|||
Gain on extinguishment of debt |
|
- |
|
|
- |
|
|
- |
|
|
366,000 |
|
|||
Other, net |
|
(38,788 |
) |
|
(10,974 |
) |
|
(27,939 |
) |
|
(14,115 |
) |
|||
Loss before income taxes |
|
(3,482,628 |
) |
|
(3,652,163 |
) |
|
(15,177,156 |
) |
|
(11,714,888 |
) |
|||
Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|
(16,043 |
) |
|||
Net loss |
|
(3,482,628 |
) |
|
(3,652,163 |
) |
|
(15,177,156 |
) |
|
(11,730,931 |
) |
|||
Net (income) loss attributable to noncontrolling interest |
|
(1 |
) |
|
- |
|
|
3 |
|
|
4 |
|
|||
Net loss attributable to Navidea and subsidiaries |
|
(3,482,629 |
) |
|
(3,652,163 |
) |
|
(15,177,153 |
) |
|
(11,730,927 |
) |
|||
Deemed dividend on preferred stock exchanged for Units |
|
- |
|
|
- |
|
|
(2,037,886 |
) |
|
- |
|
|||
Net loss attributable to common stockholders | $ |
(3,482,629 |
) |
$ |
(3,652,163 |
) |
$ |
(17,215,039 |
) |
$ |
(11,730,927 |
) |
|||
Loss attributable to common stockholders per common shares (basic and diluted) | $ | (0.11 |
) | $ | (0.12 |
) | $ | (0.56 |
) | $ | (0.40 |
) | |||
Weighted average shares outstanding (basic and diluted) |
|
32,376,900 |
|
|
30,161,825 |
|
|
30,901,869 |
|
|
29,343,542 |
|
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View source version on businesswire.com: https://www.businesswire.com/news/home/20230321005879/en/
Investor Relations Contact
Vice President of Operations
614-822-2365
jsmith@navidea.com
Source:
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