Aspira Women’s Health Announces Preliminary Second Quarter 2024 OvaSuite Product Volume and Highlights
2024年7月11日 - 9:00PM
Aspira Women’s Health Inc. (“Aspira” or the “Company”) (Nasdaq:
AWH), a bio-analytical based women’s health company focused on the
development of gynecologic disease diagnostic tools, today
announced preliminary second quarter 2024 OvaSuite product volume
and highlights.
Preliminary Second Quarter 2024 Product Volume and
Highlights
- The number of OvaWatch tests
performed during the second quarter ended June 30, 2024, was 1,307,
an increase of 48%, compared to the 884 tests in the same period
last year, and an increase of 24% to the 1,052 tests
sequentially.
- The number of OvaSuite tests
performed during the second quarter ended June 30, 2024, was 6,471,
an increase of 3% compared to the 6,289 tests in the same period
last year, and an increase of 11% to the 5,829 tests in the first
quarter.
- The Company was notified that it has
been selected as a finalist for an ARPA-H grant to support further
development of its protein + microRNA blood test for endometriosis.
Announcement of the final grant award recipients is anticipated in
the second half of 2024.
- The Company has completed a
comprehensive analysis of its biobank and has identified up to
70,000 serum, plasma, and whole blood samples that are available
for secondary research. The Company is exploring opportunities to
create non-dilutive sources of cash through related
collaborations.
“Our OvaSuite product volume, and in particular our OvaWatch
volume, has grown each month since the beginning of the year,
demonstrating that the commercial changes we made last year are
having a positive impact,” said Nicole Sandford, Chief Executive
Officer of Aspira. “The data showing OvaWatch’s clinical
effectiveness is resonating with physicians and payers alike. We
believe that OvaWatch, which at this early stage already represents
20% of total volume, will be a key component of Aspira’s future
growth. The release of the periodic monitoring feature in May
radically increased the size of the test’s addressable market to
between 2 and 4 million tests a year. Armed with a mature and
effective sales force and strong clinical data, the momentum is
clearly building.”
Ms. Sandford added, “We continue to be laser focused on cash
management. Earlier this week, we announced the closing of an
at-the-market private placement with gross proceeds of nearly $1.9
million with many of our largest shareholders and company insiders
demonstrating their support of the Company. As mentioned in our
June update, we anticipate providing a downward revision of our
cash use for operations guidance at the time of our quarterly
earnings report.”
Dr. Sandra Milligan, President of Aspira, said, “We are honored
to have been selected from the hundreds of applicants as one of the
finalists in the ARPA-H grant process and look forward to sharing
our market-leading science and development process. In the
meantime, we continue to explore additional grants and other
non-dilutive sources of funding including academic collaborations.
We believe that our extensive biobank and available samples
position us as an ideal strategic partner for others innovating in
women’s health.”
“With respect to our in-development pipeline, we continue to
progress in the design and development of our molecular tests,” Dr.
Milligan added. “We are pleased with the performance of the digital
droplet PCR platform, a crucial component of a commercially viable
test, and plan to provide a more detailed update on our quarterly
earnings call next month.”
In addition to these second-quarter highlights, the Company
recently completed a $1.9 million private placement equity
financing with broad participation from certain existing
shareholders and company insiders. Net proceeds from the offering
will support Aspira’s ongoing commercial activities as well as
general corporate purposes and working capital.
About Aspira Women’s Health Inc.Aspira Women’s
Health Inc. is dedicated to the discovery, development, and
commercialization of noninvasive, AI-powered tests to aid in the
diagnosis of gynecologic diseases.
OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM.
Together, they provide the only comprehensive portfolio of blood
tests to aid in the detection of ovarian cancer for the 1.2+
million American women diagnosed with an adnexal mass each year.
OvaWatch provides a negative predictive value of 99% and is used to
assess ovarian cancer risk for women where initial clinical
assessment indicates the mass is indeterminate or benign, and thus
surgery may be premature or unnecessary. Ova1Plus is a reflex
process of two FDA-cleared tests, Ova1® and Overa®, to assess the
risk of ovarian malignancy in women planned for surgery.
Our in-development test pipeline is designed to expand our
ovarian cancer portfolio and addresses the tremendous need for
noninvasive diagnostics for endometriosis, a debilitating disease
that impacts millions of women worldwide. In ovarian cancer, our
OvaMDxSM risk assessment is designed to combine microRNA and
protein biomarkers with patient data to further enhance the
sensitivity and specificity of our current tests. In endometriosis,
EndoCheckSM is the first-ever noninvasive test designed to identify
endometriomas, one of the most commonly occurring forms of
endometriosis. The EndoMDxSM test is designed to combine microRNA
and protein biomarkers with patient data to identify all
endometriosis.
Forward-Looking StatementsThis press release
contains forward-looking statements, as defined in the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements involve a number of risks and uncertainties. Such
forward-looking statements include statements regarding, among
other things, the timing and completion of any products in the
pipeline development and other statements that are predictive in
nature. Actual results could differ materially from those discussed
due to known and unknown risks, uncertainties, and other factors.
These forward-looking statements generally can be identified by the
use of words such as “designed to,” “expect,” “plan,” “anticipate,”
“could,” “may,” “intend,” “will,” “continue,” “future,” other words
of similar meaning and the use of future dates. Forward-looking
statements in this press release and other factors that may cause
such differences include the satisfaction of customary closing
conditions related to the offering and the expected timing of the
closing of the offering. These and additional risks and
uncertainties are described more fully in the company’s filings
with the SEC, including those factors identified as “Risk Factors”
in our most recent Annual Report on Form 10-K, for the fiscal year
ended December 31, 2023, and subsequent Quarterly Reports on Form
10-Q. If any of these risks materialize or our assumptions prove
incorrect, actual results could differ materially from the results
implied by these forward-looking statements. There may be
additional risks that Aspira presently does not know, or that
Aspira currently believes are immaterial, that could also cause
actual results to differ from those contained in the
forward-looking statements. In addition, forward-looking statements
reflect Aspira’s expectations, plans, or forecasts of future events
and views as of the date of this press release. Subsequent events
and developments may cause the Company’s assessments to change.
However, while Aspira may elect to update these forward-looking
statements at some point in the future, Aspira expressly disclaims
any obligation to do so, except as required by law. These
forward-looking statements should not be relied upon as
representing Aspira’s assessments of any date after the date of
this press release. Accordingly, undue reliance should not be
placed upon the forward-looking statements.
Investor Relations Contact: Nicole
Sandford Chief Executive
Officer Investors@aspirawh.com
Photos accompanying this announcement are available
at:https://www.globenewswire.com/NewsRoom/AttachmentNg/839c39d0-429f-436e-aaff-beed552ac624
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Aspira Womans Health (NASDAQ:AWH)
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