Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced
medical products, today announced financial results for its second
quarter of fiscal year 2021, which ended November 30, 2020.
The Company reported second quarter worldwide
revenue of $1.373 million as compared to $1.596 million for
the same period in the previous year. The decrease in sales during
the quarter was primarily due lower sales in Asia. However, sales
in Asia have substantially increased in the first half of the third
fiscal quarter. Net loss was $1.485 million for the second fiscal
quarter compared to a net loss of $0.485 million for the same
period in the previous fiscal year. The increase in net loss was
primarily due to higher research and development expense, largely
related to the development of several COVID-19 tests, and higher
general and administrative expenses, mainly due to increases in
legal fees, reserves and personnel/consulting costs. Cash and cash
equivalents were $5.684 million, and current assets were $11.947
million, at the end of the second fiscal quarter.
The Company announced that the U.S. Food and
Drug Administration (“FDA”) is now actively reviewing the Company’s
Emergency Use Authorization (“EUA”) application for its COVID-19
IgG ELISA Test along with the Company’s professional use and
at-home Whole Blood Collection Card system. If EUA clearance is
granted, it would be the first for an in-home blood sample
collection system combined with an ELISA test kit. This collection
system offers the simplicity of a finger-prick blood sample which
can be easily collected in multiple settings such as homes,
schools, workplace, community care and healthcare settings, and
have these samples sent back to a lab to be run on the Company’s
highly accurate ELISA test. In clinical studies, the finger-prick
blood collected samples demonstrated 100% specificity for detecting
IgG antibodies to the spike protein of SARS-CoV-2 and 0%
cross-reactivity with many common diseases. The Company’s COVID-19
IgG ELISA test uses modified trimeric spike protein from the
SARS-CoV-2 virus, which is known to be the target of neutralizing
antibodies that prevent the virus from entering cells.1
The Company also recently announced that it has
received a CE mark for its new antigen rapid test. The Company has
already received its first large European orders and plans to ship
the first part of these orders in the coming weeks. The Company
will now begin marketing this product broadly in Europe and other
regions outside of the U.S. Biomerica’s new COVID-19 Antigen Rapid
Test is highly portable, affordable and provides results in
approximately 15 minutes with no equipment required to perform or
read the test. This test can be performed by doctors, nurses,
school nurses, medical assistants, and trained medical specialists.
In independent testing at clinics in three different countries
outside of the U.S., the Biomerica COVID-19 Rapid Antigen Test
demonstrated an overall performance of 94.7% positive agreement
(sensitivity) and 99.7% negative agreement (specificity) as
compared to lab-based molecular PCR tests. A simple nasal swab is
used to collect specimens from people suspected of having an active
infection. Patient samples should be tested immediately and should
not be diluted or used with viral transport media or frozen
specimens.
Also, as previously announced, the Company is
nearing completion of patient enrollment in the endpoint clinical
trial for its InFoods® Irritable Bowel Syndrome (“IBS”)
diagnostic-guided therapy (“DGT”). This double-blinded, randomized,
controlled clinical trial is validating the Biomerica InFoods® IBS
test to manage the debilitating pain and suffering of patients
diagnosed with IBS. Utilizing an antibody guided blood test, the
InFoods® IBS product identifies patient-specific foods that may
alleviate IBS symptoms when eliminated from the patient’s diet.
Mayo Clinic, Beth Israel Deaconess Medical Center, Inc., a Harvard
Medical School Teaching Hospital, Houston Methodist, University of
Texas Health Science Center at Houston, and the University of
Michigan are participating in this study. Biomerica expects to
complete patient enrollment at these centers by the end of April,
2021, and to have summary analysis results from the clinical trial
by the end of July, 2021.
“We have worked to differentiate our COVID-19
products from the competition by focusing on proprietary methods of
sample collection. For example, by using our simple finger-prick
blood collection device we can enable a simple collection of a
blood sample virtually anywhere (at home, at the office, or
virtually any other location). At the same time, we are now
launching our point of care 15-minute antigen test. Most
importantly, we are very excited about nearing completion of
patient enrollment in our endpoint clinical trial for its InFoods®
IBS diagnostic-guided therapy. While we are proud to be helping
with the current global pandemic, it is important to note that our
primary long-term focus continues to be on validation and
commercialization of products based on our patented InFoods®
technology platform. We continue to believe our InFoods products
could revolutionize the way people are diagnosed and treated for a
variety of gastrointestinal diseases, while offering Biomerica
sizable revenue opportunities,” stated Zackary Irani, CEO of
Biomerica.
About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical
technology company that develops, patents, manufactures and markets
advanced diagnostic and therapeutic products used at the point of
care (in home and in physicians' offices) and in hospital/clinical
laboratories for detection and/or treatment of medical conditions
and diseases. The Company's products are designed to enhance the
health and well-being of people, while reducing total healthcare
costs. Biomerica’s primarily focus is on gastrointestinal and
inflammatory diseases where the Company has multiple diagnostic and
therapeutic products in development.
About InFoods® The Biomerica
InFoods® IBS product is designed to allow physicians to identify
patient-specific foods (e.g., eggs, broccoli, wheat, potatoes,
corn, etc.), that when removed from the diet, may alleviate or
improve an individual's IBS symptoms including, but not limited to,
constipation, diarrhea, bloating, pain and indigestion. This
patented, diagnostic-guided therapy is designed to allow for a
patient-specific, guided dietary regimen to improve IBS outcomes.
The point-of-care product is being developed to allow physicians to
perform the test in-office using a finger stick blood sample while
a clinical lab version of the product is expected to be the first
for which the Company will seek regulatory approval. A billable CPT
code that can be used by both clinical labs and physicians' offices
is already available for InFoods® diagnostic products. Since the
InFoods® product is a diagnostic-guided therapy, and not a drug, it
has no drug type side effects. An estimated 45 million people in
America currently suffer from IBS making it a leading cause for
patient doctor visits.
The Private Securities Litigation Reform Act of
1995 provides a "safe harbor" for forward-looking statements.
Certain information included in this press release (as well as
information included in oral statements or other written statements
made or to be made by Biomerica) contains statements that are
forward-looking, such as statements relating to the efficacy of the
Company’s COVID-19 tests, FDA clearance, EUA clearance, the
rapidity of testing results, uniqueness of a product, accuracy of
products, pricing of the Company’s test kits, demand for
international orders, availability of the Company’s COVID-19 test
kits, and patent protection on the test technology. Such
forward-looking information involves important risks and
uncertainties that could significantly affect anticipated results
in the future, including, without limitation: results of studies
testing the efficacy of the Company’s COVID-19 tests; regulatory
approvals necessary prior to commercialization of the Company’s
COVID-19 tests; availability of the Company’s COVID-19 test kits;
capacity, resource and other constraints on our suppliers;
dependence on our third party manufacturers; dependence on
international shipping carriers; governmental import/export
regulations; demand for our various COVID-19 tests; competition
from other similar products and from competitors that have
significantly more financial and other resources available to them;
governmental virus control regulations that make it difficult or
impossible for the company to maintain current operations;
regulations and the Company’s ability to obtain patent protection
on any aspects of its rapid test technology. Accordingly, such
results may differ materially from those expressed in any
forward-looking statements made by or on behalf of Biomerica.
Additionally, potential risks and uncertainties include, among
others, fluctuations in the Company's operating results due to its
business model and expansion plans, downturns in international and
or national economies, the Company's ability to raise additional
capital, the competitive environment in which the Company will be
competing, and the Company's dependence on strategic relationships.
The Company is under no obligation to update any forward-looking
statements after the date of this release.
1. medRxiv preprint doi:
https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun20
Corporate Contact: Company Spokeperson
949-645-2111
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