Full Press Release Details
ENDRA Life Sciences Reports First Quarter 2021 Financial Results
and Provides Business Update
Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, Mich. (May 17, 2021) ENDRA Life Sciences
(NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound
today reported financial results for the three months ended March
31, 2021 and provided a business update. Highlights of the first
quarter of 2021 and recent weeks include the
Began screening patients for real-world
clinical validation of TAEUS at Rocky Vista University College of Osteopathic
Medicine. All clinical evaluation sites will compare the
liver fat measurements of the TAEUS system to the gold standard
Partnered with Hepion
Pharmaceuticals, a clinical-stage company focused on AI-driven
therapeutic drug development for the treatment of nonalcoholic
steatohepatitis ( 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. 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
Added two sales representatives
to the commercial team in
Europe in anticipation of COVID-19-related restrictions
being lifted, bringing the ENDRA EU team to four.
Strengthened balance sheet via exercise
of warrants and proceeds from existing ATM facility. Cash and cash
equivalents as of March 31, 2021 were $16.8 million.
Strengthened TAEUS intellectual
property protection with issuance of additional U.S. patents.
Since the beginning of the year, four
U.S. patents have been issued to further protect the
Company's proprietary TAEUS technology. ENDRA's intellectual property portfolio
continues to grow and currently stands at 85 global assets, defined as patents issued, filed,
licensed or in preparation.
"We continue to advance commercialization
initiatives by driving awareness of our TAEUS system and expanding
our European sales team. In
April, ENDRA presented at the American Institute of
Ultrasound in Medicine's Annual Integrative Ultrasound
Meeting, highlighting the features and
benefits of the TAEUS system. We have several more industry conferences planned through the balance
of the year to exhibit TAEUS and expand our database of potential
customers. stated Francois Michelon, Chairman and Chief
Executive Officer of ENDRA. As we await a decision from the
U.S. FDA regarding our 510(k) application, we remain confident in
our submission and look forward to a favorable outcome. In the
interim, and unrelated to our application, we continue to support our domestic
clinical evaluation partners to assess and monitor chronic liver
Renaud Maloberti, Chief Commercial Officer, commented, "Although
the environment continues to be challenging in many European
countries as COVID-19 vaccines have not been administered as
quickly as in the U.S., our growing commercial team is
cultivating existing
clinician contacts and positioned to
develop new ones to establish a strong foundation of leads when
in-person meetings and product demonstrations resume. In addition,
this commercialization effort includes working closely with our
partner, GE Healthcare, to leverage their extensive base of
ultrasound customers. The teams' initial focus is to increase
local interest for ENDRA's technology among radiologists
while also targeting clinicians in hepatology, endocrinology and
primary care which represent a significant market opportunity for
First Quarter 2021 Financial Results
Operating expenses decreased to $2.6 million in the first quarter of 2021 from
$3.1 million in the same period
in 2020. The decrease was
primarily due to reduced spending for outsourced product
development and investor relations and legal fees.
Net loss in the first quarter of 2021 was
$2.3 million, or $0.06
per share, compared with a net loss of
$3.3 million, or $0.29
per share, in the first quarter of
Cash and cash equivalents were $16.8
million as of March 31,
In the first quarter of 2021, ENDRA received
exercise notices for 3.6 million warrants resulting in additional cash
proceeds of $2.8 million, and
sold approximately 3.9 million
shares through its ATM facility for gross proceeds of $9.8
Protection Program loan in the amount of $308,600 received during
2020 has been forgiven in full by the Small Business Administration
and was treated as Other Income' per GAAP
Conference Call and Webcast
Management will host a conference call and webcast today at 4:30
p.m. Eastern time to discuss these results, provide an update on
recent corporate developments and answer questions.
U.S./Canada: 888-506-0062
International: 973-528-0011
Replay Dial-in Numbers
U.S./Canada: 877-481-4010
International: 919-882-2331
Replay Passcode: 40908
The telephone replay will be available through 4:30 p.m. Eastern