Conference Call to be held Wednesday, August
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 second quarter and
year-to-date for the period ended June 30, 2021.
“The Company is prepared and looking forward to our meeting with
the U.S. Food and Drug Administration (“FDA”) on September 1,” said
Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “We remain
laser focused on a positive meeting and a successful launch to the
NAV3-33 trial. Navidea is also extremely excited to now have a full
7-member board with the appointments of Amit Bhalla, Alex Cappello
and John K. Scott, Jr. to the board.”
Second Quarter 2021 Highlights and Subsequent Events
- Scheduled an End-of-Phase 2 Type B meeting with the FDA to
discuss its ongoing program in Rheumatoid Arthritis (“RA”) and
advancement to the pivotal Phase 3 trial. The meeting will take
place on September 1, 2021, via conference call.
- Achieved study closeout in the Company’s NAV3-31 Phase 2b
study.
- Opened the first U.S. site, Northwestern University, as well as
the primary U.K. 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 RA. A second U.S. site, Attune Health Research, will be
opened on August 13, 2021.
- Enrolled over 115 subjects in the Company’s NAV3-35 Phase 2b
study, “Development of a Normative Database for Rheumatoid
Arthritis (RA) Imaging with Tc99m Tilmanocept.” Expected total
enrollment for this two-arm trial will be 135 participants.
- Completed 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.
- Announced the granting of a National Institutes of Health
(“NIH”) award to the University of California San Diego School of
Medicine for the proposal entitled, “Renal Molecular Imaging of
Mesangial Cell Function with Tc-99m-Tilmanocept.” The award
(Project Number: 1R01DK127201-01), from the National Institute of
Diabetes and Digestive and Kidney Diseases of the NIH, was granted
to Co-Principal Investigators UC San Diego faculty Carl Hoh, MD and
David Vera, PhD, of the Department of Radiology, and Charles
Ginsberg, MD, MAS, of the Department of Medicine, Division of
Nephrology.
- Results from the Company’s preclinical studies of its targeted
cancer immunotherapeutic agent were 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.”
- Announced that the U.S. Patent and Trademark Office (“USPTO”)
issued to Navidea U.S. patent 11,007,272, entitled “Compounds and
Methods for Diagnosis and Treatment of Viral Infections,” with
protection to October 7, 2037.
- Converted the provisional patent application “Synthesis of
Uniformly Defined Molecular Weight Mannosylated Dextrans and
Derivatives Thereof” to an A1 application on July 9, 2021.
- Appointed Amit Bhalla to the Company’s Board of Directors. Mr.
Bhalla brings a wealth of financial experience and over 20 years of
pharmaceutical experience to the board.
- Appointed John K. Scott, Jr. and Alex Cappello to the Board of
Directors. Mr. Scott is the Company’s largest shareholder and Mr.
Cappello brings over 30 years of banking and public board
experience to the Company.
- Announced that on June 23, 2021, Vice Chancellor Joseph Slights
of the Court of Chancery of the State of Delaware (the “Court”)
ruled in favor of Navidea’s wholly-owned subsidiary, Macrophage
Therapeutics, Inc. (“MT”) and against its former CEO, Dr. Michael
Goldberg, finding that Dr. Goldberg breached his fiduciary duties
to MT. In addition, the Court denied Dr. Goldberg’s motion to hold
MT’s directors and CEO in contempt, denied Dr. Goldberg’s motion to
dismiss the lawsuit against him, and granted MT’s motion to dismiss
Dr. Goldberg’s petition to remove MT’s board members.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said,
“The clinical research team continues to work diligently to advance
the technology in key disease areas, with an emphasis on our RA
program. We are preparing for our September discussion with the FDA
over the results of the completed NAV3-31 Phase 2b trial as well as
our proposed plan for the Phase 3 study. We continue to prepare for
initiation of the Phase 3 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, and we expect to continue to advance
these towards the clinic.”
Financial Results
- Total net revenues for the second quarter of 2021 were
$261,000, compared to $271,000 for the same period in 2020. Total
net revenues for the first six months of 2021 were $385,000,
compared to $427,000 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 receipt of
reimbursement from Cardinal Health 414, LLC of certain research and
development (“R&D”) costs and the partial recovery of debts
previously written off in 2015.
- R&D expenses for the second quarter of 2021 were $1.5
million, compared to $1.3 million in the same period in 2020.
R&D expenses for the first six months of 2021 were $2.7
million, compared to $2.3 million 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. The net increase in research and development
expenses also included increased regulatory consulting expenses
offset by decreased employee compensation including incentive-based
awards.
- Selling, general and administrative (“SG&A”) expenses for
the second quarter of 2021 were $1.4 million, compared to $1.3
million in the same period in 2020. SG&A expenses for the first
six months of 2021 were $3.7 million, compared to $3.2 million in
the same period in 2020. The net increase was primarily due
increased consulting services related to preparing for European
distribution of Tc99m tilmanocept, increased employee compensation
including incentive-based awards, increased insurance cost,
increased director fees related to additional board members,
increased general office expenses, increased travel costs and
increased European license fees, offset by decreased legal and
professional services and decreased investor relations costs.
- Navidea’s net loss attributable to common stockholders for the
second quarter of 2021 was $2.7 million, or $0.09 per share,
compared to $2.4 million, or $0.11 per share, for the same period
in 2020. Navidea’s net loss attributable to common stockholders for
the first six months of 2021 was $5.6 million, or $0.20 per share,
compared to $5.1 million, or $0.24 per share, for the same period
in 2020.
- Navidea ended the second quarter of 2021 with $7.1 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: Second Quarter 2021 Earnings
Conference Call and Business Update
Date: Wednesday, August 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: 13721827
Webcast Link:
https://webcast-eqs.com/navidbioph20210811/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 June 30,
December 31,
2021
2020
(unaudited) Assets: Cash and cash equivalents
$
7,114,103
$
2,670,495
Other current assets
2,929,307
3,857,833
Non-current assets
1,237,900
1,229,690
Total assets
$
11,281,310
$
7,758,018
Liabilities and stockholders' equity: Current
liabilities
$
4,024,669
$
4,715,105
Deferred revenue, non-current
700,000
700,000
Other liabilities
120,471
296,006
Total liabilities
4,845,140
5,711,111
Navidea stockholders' equity
5,704,870
1,315,604
Noncontrolling interest
731,300
731,303
Total stockholders' equity
6,436,170
2,046,907
Total liabilities and stockholders' equity
$
11,281,310
$
7,758,018
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS Three Months
Ended Six Months Ended June 30, June 30, June 30, June 30,
2021
2020
2021
2020
(unaudited) (unaudited) (unaudited) (unaudited)
Revenue
$
261,046
$
271,101
$
384,783
$
427,373
Cost of revenue
-
357
-
966
Gross profit
261,046
270,744
384,783
426,407
Operating expenses: Research and development
1,498,056
1,281,779
2,720,810
2,281,048
Selling, general and administrative
1,432,610
1,329,591
3,663,355
3,157,345
Total operating expenses
2,930,666
2,611,370
6,384,165
5,438,393
Loss from operations
(2,669,620
)
(2,340,626
)
(5,999,382
)
(5,011,986
)
Other income (expense): Interest income (expense), net
1,266
15,343
(1,609
)
12,971
Gain on extinguishment of debt
-
-
366,000
-
Other, net
(5,686
)
(336
)
(5,941
)
(212
)
Net loss
(2,674,040
)
(2,325,619
)
(5,640,932
)
(4,999,227
)
Loss (income) attributable to noncontrolling interest
1
1
3
(1
)
Deemed dividend on Series C Preferred Stock beneficial conversion
feature
-
(77,778
)
-
(77,778
)
Net loss attributable to common stockholders
$
(2,674,039
)
$
(2,403,396
)
$
(5,640,929
)
$
(5,077,006
)
Loss attributable to common stockholders per common
share (basic and diluted)
$
(0.09
)
$
(0.11
)
$
(0.20
)
$
(0.24
)
Weighted average shares outstanding (basic and diluted)
29,117,832
22,759,393
28,531,660
21,481,514
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210811005774/en/
Navidea Biopharmaceuticals, Inc. Jed Latkin Chief Executive
Officer 614-973-7490 jlatkin@navidea.com
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