OpGen Provides Business and Preliminary Financial Update
16 October 2018 - 8:35AM
OpGen, Inc. (NASDAQ: OPGN) today provided an update on its
commercial activities and clinical trials for its Acuitas® AMR Gene
Panel tests and the Acuitas Lighthouse® Software. Preliminary
unaudited results for the third quarter of 2018 were also reported.
OpGen continues to make commercial progress with the Acuitas AMR
Gene Panel and the Acuitas Lighthouse Software Research Use Only
(RUO) products. During the third quarter we were selected to
participate in a ground-breaking antimicrobial resistance
surveillance initiative across New York State. As part of the
collaboration, OpGen will receive a $1.5 million contract for the
12-month demonstration portion of the project, with the potential
for full implementation during the next four years, should certain
milestones be achieved by all parties involved. The demonstration
project revenue includes Acuitas AMR Gene Panel u5.47 (RUO) revenue
and use of the Acuitas Lighthouse Software. Revenue is expected to
be recognized during 2019. During the third quarter of 2018, the
Company sold its first Acuitas AMR Gene Panel u5.47 RUO tests. Ten
AMR Gene Panel (RUO) systems are in use in the field with both
current customers as well as prospective customers evaluating the
products for potential commercial use.
The Company’s 2017 contract with the Centers for Disease Control
and Prevention (CDC), to develop smartphone-based clinical decision
support solutions for antimicrobial stewardship (AMS) and infection
control in low- and middle-income countries, has progressed
successfully. The software is in use at three healthcare
institutions in Colombia as part of the final evaluation stage of
the contract, which has been extended into the fourth quarter of
2018 to allow for more extensive data collection and evaluation of
the system’s impact on antimicrobial stewardship and infection
control. Consequently, the final payment from the one-year award
that was originally anticipated to occur in the third quarter of
2018 is now anticipated to be recognized during the fourth quarter
of 2018.
The Company has commenced performance testing for its
Investigational Use Only (IUO) Acuitas AMR Gene Panel u5.47
(Isolates) test to support a 510(k) submission to the U.S. Food and
Drug Administration (FDA). Interactions with the FDA continue under
the Agency’s Q-Sub process to continue to clarify specific
requirements for clinical validation and clinical trials for the
Acuitas AMR Gene Panel Tests and the Acuitas Lighthouse Software.
The Company is targeting its first 510(k) submission for the end of
the fourth quarter of 2018 or in the first quarter of 2019. The
overall performance testing schedules at OpGen and at third-party
sites have been impacted by expanded FDA clinical validation
testing requirements and delays in sourcing scale-up quantities of
a key reagent for AMR Gene Panel test kits.
Total preliminary unaudited revenue for the third quarter of
2018 was approximately $550,000 compared with approximately
$750,000 in the third quarter of 2017. The decrease was due to a
decline in revenue from the Company’s legacy QuickFISH rapid
diagnostic testing products. In the third quarter of 2018 the
company anticipated a fourth payment under the CDC smartphone-based
clinical decision support solutions contract; this payment is now
expected in the fourth quarter of 2018. Total preliminary
unaudited revenue for the first nine months of 2018 was
approximately $2.2 million, compared with approximately $2.2
million for the first nine months of 2017. Cash as of September 30,
2018 was approximately $4.7 million.
“We achieved key milestones in the development of our Acuitas
AMR Gene Panel rapid testing and informatics business during the
quarter,” said Evan Jones, CEO, OpGen. “We were selected as a
partner by New York State to work collaboratively with the
Department of Health’s Wadsworth Center and ILÚM Health Solutions,
LLC, a wholly owned subsidiary of Merck’s Healthcare Services and
Solutions, to build a sustainable, flexible infectious diseases
reporting, tracking and surveillance tool for antimicrobial
resistance that can be applied across New York State. We also began
performance evaluations for the Acuitas AMR Gene Panel u5.47
Investigational Use Only (IUO) product to support FDA clearance of
the AMR Gene Panel u5.47 (Isolates) while beginning commercial
sales of the RUO product.”
About OpGen
OpGen, Inc. is harnessing the power of
informatics and genomic analysis to provide complete solutions for
patient, hospital, and network-wide infection prevention and
treatment. For more information, please visit www.opgen.com.
OpGen, Acuitas, Acuitas Lighthouse, and
QuickFISH are registered trademarks of OpGen, Inc.
The Acuitas AMR Gene Panel u5.47 (RUO) and the
Acuitas Lighthouse Software (RUO) are intended for Research Use
Only and are not for use in diagnostic procedures. The Acuitas
Lighthouse Software is not distributed commercially for antibiotic
resistance prediction and is not for use in diagnostic
procedures.
Forward-Looking Statements
This press release includes statements relating
to OpGen’s financial and business expectations. These statements
and other statements regarding OpGen’s future plans and goals
constitute "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, and are intended to qualify for
the safe harbor from liability established by the Private
Securities Litigation Reform Act of 1995. Such statements are
subject to risks and uncertainties that are often difficult to
predict, are beyond our control, and which may cause results to
differ materially from expectations. Factors that could cause our
results to differ materially from those described include, but are
not limited to, our ability to successfully, timely and
cost-effectively develop, seek and obtain regulatory clearance for
and commercialize our product and services offerings, our ability
to successfully complete the pilot portion of the NY State project,
the rate of adoption of our products and services by hospitals and
other healthcare providers, the effect on our business of existing
and new regulatory requirements, and other economic and competitive
factors. For a discussion of the most significant risks and
uncertainties associated with OpGen's business, please review our
filings with the Securities and Exchange Commission. You are
cautioned not to place undue reliance on these forward-looking
statements, which are based on our expectations as of the date of
this press release and speak only as of the date of this press
release. We undertake no obligation to publicly update or revise
any forward-looking statement, whether as a result of new
information, future events or otherwise.
OpGen Contact: Michael Farmer Vice President,
Marketing (240)
813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Investor Contacts: LHA Investor Relations Kim
Sutton Golodetz (212) 838-3777 kgolodetz@lhai.com or Bruce Voss
(310) 691-7100 bvoss@lhai.com
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