Navidea Biopharmaceuticals Announces Third-Party Asset Valuation of Tc99m Tilmanocept for Indications in Rheumatoid Arthritis
December 13 2021 - 7:30AM
Business Wire
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB)
(“Navidea” or the “Company”), a company focused on the development
of precision immunodiagnostic agents and immunotherapeutics, today
announced the results of a third-party asset valuation of its
Rheumatoid Arthritis (“RA”) diagnostic product candidate.
The Company engaged the independent third-party valuation firm,
LifeSci Partners (LifeSci Advisors, LLC), to perform a U.S.-focused
market research valuation of its advanced pipeline product Tc99m
tilmanocept for prediction of treatment efficacy of anti-TNFα
therapy in RA. A summary of the valuation report and the
assumptions on which it is based is available on the Company’s
website, www.navidea.com.
The Company is advancing its program evaluating Tc99m
tilmanocept imaging, a radiopharmaceutical that selectively targets
the CD206 receptor expressed on activated macrophages, for
indications in RA. A previously completed Phase 2B study
demonstrated results in support of the hypotheses that Tc99m
tilmanocept imaging can provide robust, quantitative imaging in
healthy controls and in patients with active RA, and that this
imaging can provide an early indicator of treatment efficacy in
patients with active RA. The planned Phase 3 trial will evaluate
the ability of Tc99m tilmanocept imaging to serve as an early
predictor of treatment response in RA patients switching to an
anti-TNFα therapy.
The valuation report used cited research and assumptions
believed to conform to industry best practices. Under base-case
assumptions that are discussed in the report, peak U.S. sales could
reach $1 billion annually, and in the upside scenario peak annual
U.S. sales could reach $1.8 billion. Opportunities for added value
include possible indication expansion to other classes of RA
therapeutics, registration of Tc99m tilmanocept imaging as a
biomarker of activated macrophages in the joints of patients with
RA, and expansion into additional geographic areas.
Dr. Michael Rosol, Navidea’s Chief Medical Officer, said, “This
report provides a third-party assessment of the potential
commercial value of Tc99m tilmanocept in the U.S. market. We have
released this in the spirit of transparency, while also giving
investors a view into the company’s internal rigor in evaluating
investments in the product pipeline.” Dr. Rosol continued, “We
believe we are on the right path to bringing a valuable tool to
bear to meet a large unmet medical need in patients with RA.
Success would mean that we can provide rheumatologists and those
suffering with RA a noninvasive, quantifiable, early indicator of
whether or not an anti-TNFα treatment is working. This could bring
enormous benefit to these patients by assisting physicians in
putting them on the right course of treatment earlier than is
possible today.”
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 fact
that the valuation by LifeSci Partners of our Tc99m tilmanocept
pipeline product is subject to and based on numerous assumptions
about the commercial success of the product, expected associated
costs, and the outcome of various risks, including the outcome of
clinical trials, that could affect the timetable for revenues,
among other assumptions, that actual outcomes are likely to vary
from such assumptions, resulting in variations from the possible
results set forth in the valuation report; 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.
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Investor Relations Contact Navidea Biopharmaceuticals,
Inc. Jeffrey Smith Vice President of Operations 614-822-2365
jsmith@navidea.com
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