Company Will Host Conference Call at 5:00 p.m. (ET) on Monday, April
8, 2019
DUBLIN, Ohio–(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 that it
received feedback from the U.S Food and Drug Administration (“FDA”)
regarding the Company’s planned clinical studies that will evaluate
joint disease in patients with Rheumatoid Arthritis (“RA”) and monitor
patient response to therapy.
Clinical Studies in Rheumatoid Arthritis
The Company’s proposed RA studies were discussed with the FDA during an
in-person meeting, and through follow-up collaborative efforts. The FDA
has communicated that the first study, a Phase 2b trial, is aligned with
expectations for the studies and that they will continue to work with
Navidea as we progress into Phase 3 clinical trials. The Company is now
prepared to initiate this study, NAV3-31 (Evaluation of the Precision
and Sensitivity of Tilmanocept Uptake Value (“TUV”) on Tc99m Tilmanocept
Planar Imaging). This study will also provide confirmatory support
necessary to initiate Navidea’s Phase 3 study program which was also
presented to the FDA. The pivotal Phase 3 study program will assess
joint disease status and monitor patient response to therapy.
Dr. Michael Rosol, Chief Medical Officer of Navidea, said, “We are
delighted to have received the news from the FDA that we are progressing
in the right direction with our upcoming Phase 2b study. This study is
designed to enable us to establish objective, quantifiable Tc99m
tilmanocept imaging metrics of the joints of healthy subjects and
patients with active RA. The robust establishment of the range of TUVs
from healthy subjects and RA patients is a critical step to set us up
for the greater validation of our imaging readout as an early biomarker
of patient response to therapy, method for longitudinal monitoring of
treatment, and potentially for RA pathobiology subtype discrimination.
Our entire clinical team has been pushing hard in preparation and this
important trial is set to begin in the near future. We plan to proceed
with our timelines and will ensure we remain in line with FDA
requirements.”
Bonnie Abbruzzese, Navidea’s Senior Director of Clinical Development,
stated, “We have identified our clinical trial study centers and have
received Investigational Review Board approval for the NAV3-31 image
stability and outcome trial, which will generate data to guide the
development of the pivotal Phase 3 trial. Our investigators are eager to
begin enrolling into the NAV3-31 protocol and we expect to inject the
first subject this quarter.”
Bill Regan, Chief Compliance Officer of Navidea, said, “As we work
towards full development of the RA program it is extremely important to
work collaboratively with the FDA to ensure continued alignment with FDA
expectations in order to achieve the Navidea goal of a successful Phase
3 program to develop the premiere diagnostic agent for patients with RA.
Input from the FDA up to this point has been very beneficial and we look
forward to continued collaboration as we progress through the complete
development program.”
Jed Latkin, Navidea’s Chief Executive Officer, commented, “This is an
important step along the path to approval of our RA diagnostic product
candidate and represents Navidea’s continued dedication to the execution
of our goals and to enhance value for stockholders. We will continue to
work with the FDA as data from NAV3-31 becomes available. We will also
continue to be transparent with the market and give updates to our
stockholders and all interested parties, as appropriate.”
RA is a chronic disease affecting over 1.3 million Americans and as much
as one percent of the worldwide population.1 Tc99m
Tilmanocept may enable, for the first time, objective visualization and
direct quantification of RA disease activity and evaluation of
joint-specific inflammation. If the product is successfully developed,
Navidea would expect to play a major role in the management of RA
patients worldwide.
Reference
1. https://www.rheumatoidarthritis.org/ra/facts-and-statistics/
Receipt of NYSE American Deficiency Letter
Navidea also announced today that it received a notification (the “NYSE
Letter”) from the NYSE American LLC (the “NYSE American”) stating that
Navidea was not in compliance with Section 1003(a)(i) of the NYSE
American Company Guide, which requires an issuer to have stockholders’
equity of $2.0 million or more if it has reported losses from continuing
operations and/or net losses in two of its three most recent fiscal
years. The NYSE Letter noted that Navidea’s most recent Form 10-K
reported stockholders’ equity of $1.7 million as of December 31, 2018,
and that Navidea has reported losses from continuing operations and/or
net losses in its five most recent fiscal years ended December 31, 2018.
Navidea previously disclosed, among other things, that it received a
notification from the NYSE American stating that Navidea was not in
compliance with Section 1003(f)(v) of the NYSE American Company Guide,
which relates to the selling price per share of the Company’s
securities. The NYSE American staff initially granted Navidea a plan
period through February 14, 2019 to regain compliance with Section
1003(f)(v) by effecting a reverse stock split or otherwise demonstrating
sustained price improvement. In January 2019, the NYSE American granted
the Company an extension until March 31, 2019 to regain compliance with
Section 1003(f)(v) of the NYSE American’s continued listing standards,
and on March 22, 2019 Navidea announced that it was in discussions with
the NYSE American regarding the timing of a potential reverse stock
split later than March 31, 2019. The NYSE Letter advised that the
Company must provide the NYSE American with a plan to regain compliance
with the price standard by April 15, 2019 in order to be considered for
continued trading through its equity plan period end date of February
14, 2020, subject to periodic review of progress consistent with the
equity plan.
In August 2018, Navidea’s stockholders voted to approve a potential
amendment to the Company’s amended and restated certificate of
incorporation to effect a reverse split of the Company’s common stock,
as determined by the Board of Directors at its discretion, of a ratio of
not less than one-for-five and not more than one-for-twenty. In addition
to the goal to regain compliance of the listing standards, the Company
believes that if the reverse split is effected, a higher share price may
attract additional brokerage firms and institutional investors who
previously may have been prohibited from investing in shares of the
Company.
Navidea’s Common Stock will continue to be listed on the NYSE American
while it attempts to regain compliance with the listing standards noted,
subject to Navidea’s compliance with other continued listing
requirements.
Conference Call Details
Investors and the public are invited to dial-in to a conference call to
discuss these business updates 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: | FDA Feedback on Rheumatoid Arthritis Trials; Other Business Updates | ||||
| Date: | Monday, April 8, 2019 | ||||
| Time: | 5:00 pm (Eastern Time) | ||||
| U.S. & Canada Dial-in: | 877-407-0312 | ||||
| Conference ID: | 13689696 | ||||
| Webcast Link: |
The recorded conference call can be replayed and will be available for
90 days following the call, available on the investor relations page of
Navidea’s corporate website at www.navidea.com.
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. The development
activities of the Manocept immunotherapeutic platform are being
conducted by Navidea in conjunction with its subsidiary, Macrophage
Therapeutics, Inc. Navidea’s strategy is to deliver superior growth and
stockholder 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 release and any oral statements made with respect to the
information contained in this 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.
These forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including, among other things: any future
actions by Platinum-Montaur; general economic and business conditions,
both nationally and in our markets; our history of 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; our expectations and
estimates concerning future financial performance, financing plans and
the impact of competition; our ability to raise capital sufficient to
fund our development and commercialization programs; our ability to
implement our growth strategy; anticipated trends in our business;
advances in technologies; our ability to comply with the NYSE American
continued listing standards; our ability to maintain effective internal
control over financial reporting; 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 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.
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin, CEO, 614-973-7490
jlatkin@navidea.com