Full Press Release Details
ENDRA Life Sciences Reports 2020 Fourth Quarter and Full Year
Financial Results, Provides Business Update
Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, Mich. (March 25, 2021) ENDRA Life Sciences
(NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound
today reported financial results for the three and twelve months
ended December 31, 2020 and provided a business update. Highlights
of the fourth quarter of 2020 and recent weeks include the
Partnered with Hepion
Pharmaceuticals, Inc. (NASDAQ: HEPA), a clinical-stage
biopharmaceutical company focused on AI-driven therapeutic drug
development for the treatment of NASH and liver disease.
signed a collaboration agreement with Hepion to incorporate TAEUS
as an add-on technology to support Hepion's patient screening and
biomarker measurement during its upcoming Phase 2b study of
Secured a new clinical study
partnership with Inselspital University Hospital in Bern,
Switzerland. This is the third
clinical research partnership for ENDRA in Europe and the sixth
globally. The data from the Inselspital Bern study, along with
other ongoing or to-be-initiated studies, will be used to bolster
clinical evidence and further establish the clinical utility of the
TAEUS device for assessing Non-Alcoholic Fatty Liver Disease
Began screening patients for
real-world clinical validation. The first patient in a clinical study by an ENDRA
clinical research partner took place at Rocky Vista University
College of Osteopathic Medicine ( RVUCOM ). The TAEUS
system was installed at RVUCOM's Ivins, Utah location in
November 2020 with the first patient of a targeted 200, scanned
Strengthened TAEUS intellectual
property protection with issuance of two additional U.S. and one Chinese
intellectual property portfolio continues to grow and currently
stands at 82 global assets,
defined as patents issued, filed, licensed or in
Extended collaboration
agreement with GE Healthcare for two additional years.
GE Healthcare will continue to support
ENDRA's commercialization activities for its TAEUS technology for
use in a fatty liver application by, among other things,
facilitating introductions to GE Healthcare clinical ultrasound
customers worldwide.
Strengthened balance sheet with receipt of
$18.5 million from the sale of common
stock. As previously announced
on December 18, 2020, the Company sold 7.9 million shares of common
stock for gross proceeds of $5.5 million. Subsequent to the year
end, the Company has raised an additional $10.1 million from its
at-the-market ( ATM ) offering via the sale of 3.9
million shares at a weighted average cost of $2.58 per share, and
$2.9 million from the cash exercise of approximately 3.6 million
Executed first distribution
agreement for TAEUS. Quang Phat
Technology Science Equipment Co. Ltd, signed an exclusive
distribution agreement for the initial sale of up to 40 TAEUS liver
systems in Vietnam. Sales are expected to begin as soon as TAEUS
receives U.S. Food and Drug Administration (FDA) clearance and
local regulatory approvals.
"Despite the challenges related to COVID-19 we faced throughout
most of 2020, I am delighted with the progress the ENDRA team made
to advance our commercialization strategy for the TAEUS system. We
finished the year strong and are doing everything within our
control to prepare for success when the healthcare system resumes
services at pre-pandemic levels. This includes actively
communicating with the FDA regarding our 510(k) submission in
preparation for the potential clearance to begin commercialization
in the U.S., stated Francois Michelon, Chairman and Chief
Executive Officer of ENDRA. At the same time, we remain
focused on gathering additional data to bolster TAEUS'
clinical utility to assess and monitor chronic liver conditions.
While unrelated to our FDA application, we believe these
independent evaluations will assist our future commercialization
efforts by documenting TAEUS' clinical and economic value
Renaud Maloberti, Chief Commercial Officer, added, "As we
experience an improving environment with the easing of restrictions
as COVID-19 cases decrease globally, our clinical study partners
are enthusiastic to move forward with their TAEUS evaluations, a
key part of our launch strategy. In parallel, we are building our
European sales team, members of which are collaborating with GE
Healthcare and engaging with clinicians via Zoom. We believe ENDRA
is poised to begin reporting commercial sales in 2021 as we address
this significant market opportunity with a differentiated product
and compelling benefits to physicians, patients and healthcare
Fourth Quarter 2020 Financial Results
Operating expenses decreased to $2.3 million in the fourth quarter of 2020, down
from $3.1 million in the same period in 2019. The
decrease was primarily due to expenses
related to the development of TAEUS as the product was
substantially completed and ready for sale.
Net loss in the fourth quarter of 2020 was
($0.10) per share, compared
with a net loss of $4.8 million
in the fourth quarter of 2019.
Full Year 2020 Financial Results
Operating expenses increased to $11.5
million in 2020, up from $10.8
million in 2019. The increase
in general and administration expenses and sales and marketing, was
partially offset by decreased spending in research and
Net loss in 2020 was $11.7 million, or ($0.63) per share, compared with a net
loss of $13.3 million, or