Conference Call to be held Wednesday, March 24,
2021 at 5:00 pm EDT
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 fourth quarter and full
year for the period ended December 31, 2020.
“We are very excited about the progress we have made, completing
all the patients in the Phase 2B NAV3-31 trial and submitting our
briefing book to the FDA were milestone accomplishments this past
year,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea.
“We are looking forward to hearing back from the FDA and continuing
our due diligence discussions with Jubilant over the near
term.”
Fourth Quarter 2020 Highlights and Subsequent Events
- Announced positive results from continued analysis of subjects
who have completed Arm 3 of the Company’s NAV3-31 Phase 2B study.
These data further corroborated Navidea’s hypotheses that Tc99m
tilmanocept imaging can provide robust, quantitative imaging in
patients with active rheumatoid arthritis (“RA”) and that this
imaging can provide an early indicator of treatment efficacy.
- Submitted a formal Type B Meeting Request to the U.S. Food and
Drug Administration (“FDA”). The FDA granted the Type B meeting and
the Company has submitted the Briefing Book. The FDA is currently
reviewing these formal briefing documents containing results from
the NAV3-31 Phase 2B study and the proposed Phase 3 design and
protocol.
- Achieved last patient, last visit in the Company’s NAV3-31
Phase 2B study. Study closeout and data analysis are ongoing.
- Opened the first US site, Northwestern University, for
enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m
tilmanocept imaging to histopathology of joints of patients with
active RA.
- Continued enrollment in the Investigator Initiated Phase 2
trial being run at the Massachusetts General Hospital evaluating
Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected
individuals.
- Received notice of patent grant from the USPTO for US
10,806,803: “Compositions for targeting macrophages and other CD206
high expressing cells and methods of treating and diagnosis.”
- Received a notice of allowance from the USPTO for the patent
application: “Compounds and methods for diagnosis and treatment of
viral infections” (US Patent Application 15/729,635).
- Performed preclinical studies that demonstrate macrophage
phenotype change from an immunosuppressive to a pro-inflammatory
state and a synergistic effect on tumor growth reduction using the
Company’s doxorubicin-containing construct with an approved
checkpoint inhibitor therapy.
- Appointed Malcolm G. Witter to the Company’s Board of
Directors. Mr. Witter brings decades of financial and corporate
governance experience to the board.
- Entered into a Stock Purchase Agreement and Letter of
Investment Intent with an existing investor, pursuant to which the
Company issued to the investor 50,000 shares of newly-designated
Series E Redeemable Convertible Preferred Stock (the “Series E
Preferred Stock”) for an aggregate purchase price of $5.0 million.
The Series E Preferred Stock is convertible into a maximum of
2,173,913 shares of Common Stock.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said,
“The clinical research team is working diligently to advance the
technology in key disease areas, with an emphasis on our RA
program. We have completed all patients and all visits in our
NAV3-31 Phase 2B trial and we are eagerly anticipating feedback
from the FDA on our briefing package and design of the Phase 3
trial. We continue to prepare for initiation of this trial and have
also opened up enrollment for the NAV3-32 Phase 2B trial comparing
tilmanocept imaging to synovial tissue biopsy samples of RA
patients. Concurrent with all of this, we have made exciting
progress in our therapeutics pipeline and will continue to advance
these towards the clinic.”
Financial Results
- Total net revenues for the fourth quarter 2020 were $219,000,
compared to $119,000 for the same period in 2019. Total net
revenues for the full year of 2020 were $914,000, compared to
$651,000 for 2019. The increases were primarily due to increased
grant revenue related to Small Business Innovation Research grants
from the National Institutes of Health supporting Manocept™
development coupled with increased license revenue from net
transitional sales in Europe.
- Research and development (“R&D”) expenses for the fourth
quarter of 2020 were $1.3 million, compared to $1.7 million in the
same period in 2019. R&D expenses for the full year of 2020
were $4.9 million, compared to $5.3 million in the same period in
2019. The decreases were primarily due to net decreases in drug
project expenses, including decreased Manocept therapeutic
development costs, decreased Manocept diagnostic development costs,
and decreased Tc99m development costs, offset by increased NAV4694
development costs. The net decreases also included decreased
regulatory consulting and travel expenses offset by increased
employee compensation.
- Selling, general and administrative (“SG&A”) expenses for
the fourth quarter of 2020 were $1.7 million, compared to $1.2
million in the same period in 2019. SG&A expenses for the full
year of 2020 were $6.7 million, compared to $6.3 million in 2019.
The net increases were primarily due to increased legal and
professional services, employee compensation, European Medicines
Agency annual fees for Lymphoseek, and franchise taxes, offset by
decreased travel, depreciation and amortization, losses on disposal
of assets, insurance, and investor relations services.
- Navidea’s net loss attributable to common stockholders for the
fourth quarter of 2020 was $3.0 million, or $0.11 per share,
compared to $2.8 million, or $0.15 per share, for the same period
in 2019. Navidea’s net loss attributable to common stockholders for
the full year of 2020 was $11.4 million, or $0.48 per share,
compared to $10.9 million, or $0.76 per share, for 2019.
- Navidea ended the fourth quarter of 2020 with $2.7 million in
cash and cash equivalents. Since December 31, 2020, the Company has
received $7.9 million of cash related to the Series D and Series E
Preferred Stock funding transactions. To date, the Company has
received over $14 million of proceeds from the issuance of Series
C, Series D and Series E Preferred stock.
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:
Q4 2020 Earnings and Business Update
Conference Call
Date:
Wednesday, March 24, 2021
Time:
5:00 p.m. (EDT)
U.S. & Canada Dial-in:
877-407-0312
International Dial-in:
+1 201-389-0899
Conference ID:
13714810
Webcast Link:
https://webcasts.eqs.com/navidbioph20210324/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
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 December 31, December 31,
2020
2019
(unaudited) Assets: Cash and cash equivalents
$
2,670,495
$
1,047,159
Other current assets
3,857,833
1,868,624
Non-current assets
1,229,690
1,235,123
Total assets
$
7,758,018
$
4,150,906
Liabilities and stockholders' equity (deficit): Current
liabilities
$
4,715,105
$
3,819,551
Deferred revenue, non-current
700,000
700,000
Other liabilities
296,006
512,344
Total liabilities
5,711,111
5,031,895
Navidea stockholders' equity (deficit)
1,315,604
(1,612,292
)
Noncontrolling interest
731,303
731,303
Total stockholders' equity (deficit)
2,046,907
(880,989
)
Total liabilities and stockholders' equity (deficit)
$
7,758,018
$
4,150,906
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS Three Months Ended Twelve Months Ended
December 31, December 31, December 31, December 31,
2020
2019
2020
2019
(unaudited) (unaudited) (unaudited) Revenue
$
219,251
$
119,299
$
915,013
$
657,826
Cost of revenue
-
108
1,048
6,667
Gross profit
219,251
119,191
913,965
651,159
Operating expenses: Research and development
1,271,141
1,725,484
4,930,187
5,338,267
Selling, general and administrative
1,748,680
1,165,797
6,694,959
6,275,409
Total operating expenses
3,019,821
2,891,281
11,625,146
11,613,676
Loss from operations
(2,800,570
)
(2,772,090
)
(10,711,181
)
(10,962,517
)
Other income (expense): Interest income (expense), net
(1,478
)
1,952
11,344
25,288
Other, net
(21,078
)
(1,733
)
(21,855
)
(7,613
)
Loss before income taxes
(2,823,126
)
(2,771,871
)
(10,721,692
)
(10,944,842
)
Benefit from (provision for) income taxes
-
-
-
(707
)
Loss from continuing operations
(2,823,126
)
(2,771,871
)
(10,721,692
)
(10,945,549
)
Loss from discontinued operations, net of tax effect
-
-
-
(2,665
)
Net loss
(2,823,126
)
(2,771,871
)
(10,721,692
)
(10,948,214
)
Loss (income) attributable to noncontrolling interest
1
(33
)
-
(17
)
Deemed dividend on Series C and Series D preferred stock beneficial
conversion feature
(180,556
)
-
(663,889
)
-
Net loss attributable to common stockholders
$
(3,003,681
)
$
(2,771,904
)
$
(11,385,581
)
$
(10,948,231
)
Loss per common share (basic and diluted): Continuing operations
$
(0.11
)
$
(0.15
)
$
(0.48
)
$
(0.76
)
Attributable to common stockholders
$
(0.11
)
$
(0.15
)
$
(0.48
)
$
(0.76
)
Weighted average shares outstanding (basic and diluted)
26,724,753
18,283,512
23,896,001
14,393,360
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210324005943/en/
Navidea Biopharmaceuticals, Inc. Jed Latkin Chief Executive
Officer 614-973-7490 jlatkin@navidea.com Joel Kaufman Chief
Business Officer 614-822-2372 jkaufman@navidea.com
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