Conference Call to be held Thursday, May 12,
2022 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, 2022.
First 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 positive preliminary results from the Company’s
ongoing NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging
to histopathology of joints of patients with active RA. Two
non-overlapping classes that align with the fibroid and non-fibroid
histological pathotypes were identified, supporting the hypothesis
that these classes can be identified by Tc99m tilmanocept
imaging.
- Received regulatory approval for Lymphoaim in India.
- Filed two new provisional patent applications. Both are related
to new methods to maximize target-tissue uptake and reduce
off-target binding. These have important implications for pipeline
applications.
- Received Notices of Allowed Claims for patent applications in
the United States, Israel, Australia, and Japan.
- Closed on a $1.5 million bridge loan from the Company’s Vice
Chair of the Board of Directors, John K. Scott, Jr.
- Adopted a plan designed to protect the Company’s net operating
loss and tax credit carryforwards.
- Continued to work on financing for the Company. We have engaged
with multiple investment banks and options are being pursued.
- Settled litigation with Platinum-Montaur Life Sciences
LLC.
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. The NAV3-33 Phase 3 and NAV3-32 Phase 2b trials continue
to enroll. We are pleased with the preliminary positive results
from the NAV3-32 study that thus far support our hypothesis that we
can distinguish between fibroid and non-fibroid pathotypes of RA
with a single scan.” Dr. Rosol continued, “Concurrent with all of
this, we continue to make progress in our therapeutics pipeline,
and we expect to keep advancing these towards the clinic.”
Financial Results
- Total net revenues for the first quarter of 2022 were $0,
compared to $124,000 for the same period in 2021. The decrease was
primarily due to the 2021 partial recovery of debts previously
written off in 2015 coupled with recognition of license revenue
related to transitional sales in Europe in 2021.
- Research and development expenses for the first quarters of
both 2022 and 2021 were $1.2 million. Decreases in Manocept
diagnostic and Tc99m tilmanocept development costs and decreased
regulatory consulting expenses were offset by increased Manocept
therapeutic development costs, employee compensation including
fringe benefits and incentive-based awards, and recruiting
expenses.
- Selling, general and administrative expenses for the first
quarter of 2022 were $1.8 million, compared to $2.2 million in the
same period in 2021. Decreases in employee compensation including
fringe benefits and incentive-based awards, legal and professional
services, general office expenses, travel, franchise taxes and
investor relations costs were offset by increased director fees,
losses on the abandonment of certain intellectual property and
increased insurance costs.
- Navidea’s net loss attributable to common stockholders for the
first quarter of 2022 was $3.0 million, or $0.10 per share,
compared to $3.0 million, or $0.11 per share, for the same period
in 2021.
- Navidea ended the first quarter of 2022 with $1.2 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. Dr. Michael Rosol, Chief
Medical Officer, and Erika Eves, Vice President of Finance and
Administration, will host the call and webcast to discuss the
financial results and provide an update on recent developments and
clinical progress. Management will be available to answer questions
live immediately following the earnings announcement and prepared
remarks portion of the call.
To participate in the call and webcast, please refer to the
information below:
Event: First Quarter 2022 Earnings Conference
Call and Business Update
Date: Thursday, May 12, 2022
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 800-285-6670
International Dial-In: +1 713-481-1320
Conference ID: 512400
Webcast Link:
https://www.webcast-eqs.com/navidbioph20220512/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,
2022
2021
(unaudited) Assets: Cash and cash equivalents
$
1,217,114
$
4,230,865
Other current assets
1,106,276
1,152,420
Non-current assets
1,278,735
1,261,548
Total assets
$
3,602,125
$
6,644,833
Liabilities and stockholders' (deficit) equity: Current
liabilities
$
4,900,268
$
5,299,802
Deferred revenue, non-current
800,000
700,000
Other liabilities
11,299
20,288
Total liabilities
5,711,567
6,020,090
Total stockholders' deficit
(2,401,960
)
(106,556
)
Noncontrolling interest
292,518
731,299
Navidea stockholders' (deficit) equity
(2,109,442
)
624,743
Total liabilities and stockholders' (deficit) equity
$
3,602,125
$
6,644,833
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months
Ended March 31, March 31,
2022
2021
(unaudited) (unaudited) Revenue
$
-
$
123,737
Cost of revenue
-
-
Gross profit
-
123,737
Operating expenses: Research and development
1,169,254
1,222,754
Selling, general and administrative
1,810,029
2,230,745
Total operating expenses
2,979,283
3,453,499
Loss from operations
(2,979,283
)
(3,329,762
)
Other income (expense): Interest expense, net
(3,662
)
(2,875
)
Gain on extinguishment of debt
-
366,000
Other, net
(4,299
)
(255
)
Net loss
(2,987,244
)
(2,966,892
)
Loss attributable to noncontrolling interest
2
2
Loss attributable to common stockholders
$
(2,987,242
)
$
(2,966,890
)
Loss attributable to common stockholders per common share
(basic and diluted)
$
(0.10
)
$
(0.11
)
Weighted average shares outstanding (basic and diluted)
30,207,746
28,066,296
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version on businesswire.com: https://www.businesswire.com/news/home/20220512005389/en/
Investor Relations Contact Navidea Biopharmaceuticals,
Inc. Jeffrey Smith Vice President of Operations 614-822-2365
jsmith@navidea.com
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