Conference Call to be held Tuesday, May 11,
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 first quarter for the
period ended March 31, 2021.
“We are continuing a positive dialogue with the FDA and are
moving as quickly as we can to fully document all the data from Arm
3 of NAV3-31,” said Mr. Jed A. Latkin, Chief Executive Officer of
Navidea. “We are also excited to begin patient enrollment for
NAV3-32 both here in the U.S. and in the UK.”
First Quarter 2021 Highlights and Subsequent Events
- Submitted a formal Type B Meeting Request to the U.S. Food and
Drug Administration (“FDA”). The FDA granted the Type B Meeting and
reviewed the formal briefing documents Navidea submitted containing
results from the NAV3-31 Phase 2B study and the proposed Phase 3
design and protocol. Following the feedback received from the FDA
at the end of March 2021, the Company continues to work toward
completing the analysis of the full trial dataset in preparation
for the standard End of Phase 2 Type B meeting and in preparation
for the Phase 3 study.
- 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, as well as
the primary UK site, Queen Mary University of London, for
enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m
tilmanocept imaging to histopathology of joints of patients with
active rheumatoid arthritis (“RA”).
- Opened the NAV3-35 trial to establish a normative database of
healthy controls for Tc99m tilmanocept imaging in rheumatoid
arthritis.
- 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 a notice of allowance from the United States Patent
and Trademark Office for the patent application: “Compounds and
methods for diagnosis and treatment of viral infections” (U.S.
Patent Application 15/729,635).
- Announced that the results from the Company’s preclinical
studies of its targeted cancer immunotherapeutic agent will be
presented as a poster at the New York Academy of Science’s (“NYAS”)
Frontiers in Cancer Immunotherapy Symposium 2021. The poster is
titled, “Targeted Delivery of Doxorubicin (DOX) to Tumor Associated
Macrophages (TAMs) Beneficially Alters the Tumor Immune
Microenvironment and Synergizes the Activity of Anti-CTLA4.”
- 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.
- Appointed Amit Bhalla to the Company’s Board of Directors. Mr.
Bhalla brings a wealth of financial experience to the board.
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 are completing the analysis of the full dataset from
the NAV3-31 Phase 2B trial as well as planning for the Phase 3
trial. We continue to prepare for initiation of this trial and have
opened up key sites for enrollment into the NAV3-32 Phase 2B trial
comparing tilmanocept imaging to synovial tissue biopsy samples of
RA patients. Concurrent with all of this, we continue to make
exciting progress in our therapeutics pipeline, some of which will
be presented this month at the NYAS conference, and we expect to
continue to advance these towards the clinic.”
Financial Results
- Total net revenues for the first quarter of 2021 were $124,000,
compared to $156,000 for the same period in 2020. The decrease was
primarily due to decreased grant revenue related to Small Business
Innovation Research grants from the National Institutes of Health
supporting Manocept™ development, offset by the partial recovery in
the first quarter of 2021 of debts previously written off in
2015.
- Research and development expenses for the first quarter of 2021
were $1.2 million, compared to $999,000 in the same period in 2020.
The increase was primarily due to net increases in drug project
expenses, including increased Manocept diagnostic and therapeutic
development costs and increased Tc99m development costs, offset by
decreased employee compensation.
- Selling, general and administrative expenses for the first
quarter of 2021 were $2.2 million, compared to $1.8 million in the
same period in 2020. The net increase was primarily due to
increased legal and professional services, insurance, investor
relations services, and employee compensation, offset by decreased
franchise taxes.
- Navidea’s net loss attributable to common stockholders for the
first quarter of 2021 was $3.0 million, or $0.11 per share,
compared to $2.7 million, or $0.13 per share, for the same period
in 2020.
- Navidea ended the first quarter of 2021 with $7.5 million in
cash and cash equivalents.
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:
Q1 2021 Earnings and Business Update
Conference Call
Date:
Tuesday, May 11, 2021
Time:
5:00 p.m. (EDT)
U.S. & Canada Dial-in:
877-407-0312
International Dial-in:
+1 201-389-0899
Conference ID:
13718969
Webcast Link:
https://webcasts.eqs.com/navidbioph20210511/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 March 31, December 31,
2021
2020
(unaudited) Assets: Cash and cash equivalents
$
7,507,319
$
2,670,495
Other current assets
1,320,720
3,857,833
Non-current assets
1,249,036
1,229,690
Total assets
$
10,077,075
$
7,758,018
Liabilities and stockholders' equity: Current liabilities
$
4,158,754
$
4,715,105
Deferred revenue, non-current
700,000
700,000
Other liabilities
209,439
296,006
Total liabilities
5,068,193
5,711,111
Navidea stockholders' equity
4,277,581
1,315,604
Noncontrolling interest
731,301
731,303
Total stockholders' equity
5,008,882
2,046,907
Total liabilities and stockholders' equity
$
10,077,075
$
7,758,018
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months
Ended March 31, March 31,
2021
2020
(unaudited) (unaudited) Revenue
$
123,737
$
156,272
Cost of revenue
-
609
Gross profit
123,737
155,663
Operating expenses: Research and development
1,222,754
999,269
Selling, general and administrative
2,230,745
1,827,754
Total operating expenses
3,453,499
2,827,023
Loss from operations
(3,329,762
)
(2,671,360
)
Other income (expense): Interest expense, net
(2,875
)
(2,372
)
Gain on extinguishment of debt
366,000
-
Other, net
(255
)
124
Net loss
(2,966,892
)
(2,673,608
)
Less (loss) income attributable to noncontrolling interest
(2
)
2
Net loss attributable to common stockholders
$
(2,966,890
)
$
(2,673,610
)
Loss attributable to common stockholders per common share
(basic and diluted)
$
(0.11
)
$
(0.13
)
Weighted average shares outstanding (basic and diluted)
28,066,296
20,203,636
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version on businesswire.com: https://www.businesswire.com/news/home/20210511006055/en/
Navidea Biopharmaceuticals, Inc. Jed Latkin Chief Executive
Officer 614-973-7490 jlatkin@navidea.com
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