OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease, to issued two letters to
stockholders from new OpGen CEO Oliver Schacht and Chairman of the
Board William Rhodes. Both letters can be found in full below:
Dear Stockholders,
As the newly appointed president and CEO of
OpGen I want to take a moment to formally introduce myself and
share the vision our new management team has for the company with
regards to our business outlook, product pipeline and growth
strategy for this year and beyond. This is an exciting time for
OpGen, and I very much look forward to working with the entire team
through the next phase of its growth.
For the past nine years I served as CEO of
Curetis and have a strong background in corporate finance and
molecular diagnostics, as demonstrated by my 13 years as CFO of
Epigenomics AG (Berlin, Germany) and the six years also as CEO of
Epigenomics Inc. (Seattle, USA). Our newly blended management team
here at OpGen has extensive experience in developing and
implementing commercial strategies and financing measures –
critical assets as the company moves forward. I expect seamless
operational continuity with Tim Dec, OpGen’s CFO who will continue
in his role, and Curetis’ Johannes Bacher, OpGen’s new COO, in
captaining the ship that is our newly combined company.
This business combination is centered on
achieving high growth while leveraging operational efficiencies and
maintaining financial discipline as we press forward toward our
primary vision – to help solve the looming AMR crisis while
preserving antibiotics as effective weapons through more advanced,
rapid diagnostic testing. Our state-of-the-art robotic
manufacturing facility in Germany, as well as our strong U.S. sales
and marketing team and dedicated European commercial partner
support team, will be key assets in our post-combination success.
OpGen, with Ares Genetics, has access to even more advanced
bioinformatics capabilities that can be leveraged to integrate the
company's AMR databases, data analytics and reporting platforms to
innovate next-generation sequencing-based solutions for infectious
disease diagnostics in the future. These synergies are undoubtedly
drivers of the core business and are expected to increase
stockholder value.
Our mission at OpGen is to develop, manufacture
and commercialize novel solutions for rapid, molecular diagnostics
of severe life-threatening infectious diseases in hospitalized
patients. Our company offers integrated solutions that cover unique
and differentiated diagnostics test panels, powerful AI-driven
bioinformatics and software tools that help find and track
multidrug-resistant microorganisms (MDROs). Our ability to do so
will depend on us achieving certain milestones in the short,
medium, and long term, as I’ll outline below.
We must first complete the post-combination
integration between the OpGen and Curetis and Ares Genetics
businesses across all international teams within the U.S., Germany
and Austria offices, which we are working on with full speed to
complete as soon as possible. From a product standpoint, our
near-term business rollout includes the anticipation of combining
Ares Genetics and Acuitas Lighthouse databases and bioinformatics
capabilities to bring a combined offering to customers, partners
and labs globally. A key milestone for the company will be the
expected near-term FDA clearance decision for our Acuitas AMR Gene
Panel (Isolates) diagnostic test. We are working actively with the
FDA to address any last remaining open items from the interactive
review process. While we anticipate the review process is nearing
completion, we still expect COVID-19 related delays to the second
interactive response review and final timing is hard to predict at
this point. As we work through that FDA process, we will also
evaluate and prioritize across the entire OpGen group portfolio of
R&D programs, platforms, and product development opportunities
to select those that we believe have biggest impact and stockholder
value creation potential in the near term as well as longer term
growth potential.
As we look beyond this year, we will seek to
consolidate the existing OpGen and Curetis diagnostic test menu on
fewer platforms and anticipate bringing the Unyvero A30 RQ platform
to market with strategic partners. The rollout and launch of the
Unyvero platform and pneumonia test pending China NMPA approval
will be a key milestone for the company. Additionally, we hope to
bring the combined OpGen portfolio of products to global markets in
Europe, Asia Pacific and other global markets through our strong
distribution network that we expect to continue to expand further
over time. We will also seek to raise additional capital for OpGen.
We will consider all instruments at our disposal in terms of
equity, debt, non-dilutive grant funding as well as partnering and
licensing models as a source of further non-dilutive funding with
the consistent goal of optimizing stockholder value.
In closing, I am confident that we will be able
to establish OpGen as an industry leader in the fight against AMR.
We anticipate this business combination will maximize value for our
stockholders through a broad and exciting product portfolio with
proprietary assets for developing and commercializing innovative,
data-driven solutions in infectious disease diagnostics. We
anticipate for these reasons our top-line revenue will continue to
grow in the years ahead as we use operational efficiencies and
synergies to reduce cash burn. Together, with your continued
support, we aim to create sustainable stockholder value and expand
our proprietary product portfolio capabilities through seeking
opportunities that present significant growth potential for the
company.
Yours sincerely, Oliver Schacht, PhD CEO, OpGen, Inc.
Dear Stockholders,
In this exciting time for OpGen, I am honored to
have been elected as the Chairman of the Board of the Directors of
OpGen following the completion of its business combination
transaction with Curetis. After five years as Chairman of the
Supervisory Board for Curetis and a 14-year career at Becton
Dickinson and Company (BD, 1998-2012), where I held several senior
leadership positions, I am delighted to be chairing this
distinguished Board of Directors and anticipate significant,
value-creating opportunities for the company. OpGen has been
developing industry leading, AI-powered diagnostics and data-driven
solutions serving hospitals and patients successfully for many
years. This is a particularly dynamic time for our enterprise as we
integrate the two businesses and push to further diversify our
product portfolio.
Our newly constituted Board consists of six
members representing expertise from both companies; there are
currently four members named by Curetis and two from the
pre-combination Board of OpGen. Changes to the Board include Evan
Jones, formally OpGen chairman and CEO to join as a non executive
director who will help with the transition. Don Elsey will continue
as chair of the audit committee joined by Mario Crovetto and Prabha
Fernandes, former Supervisory Board directors of Curetis. Thus, the
reconstituted Board of Directors consists of myself, Mr. Schacht,
Mr. Jones. Mr. Crovetto, Dr. Fernandes, and Don Elsey. These
individuals bring a strong understanding of the diagnostic and AMR
space as well as significant finance, healthcare, marketing and
business development expertise. I look forward to working with such
a diverse and talented group of individuals as we lead the company
towards value-creating opportunities.
Since the beginning, the cornerstone of success
of our pre-combination businesses has been the shared vision and
mission to develop, manufacture and commercialize proprietary
solutions for rapid, molecular diagnostics of severe
life-threatening infectious diseases. Following completion of our
combination, our fundamental business now offers a much broader,
diversified portfolio of products, platforms and bioinformatic
solutions. Not only do our business outlooks and industry goals
mirror one another, but our combined management and executive teams
complement each other as one new combined team.
As we embark on integrating our businesses,
teams and products over the coming months, the pace and success of
our pipeline rollout will largely be determined by the successful
execution of our integration strategies. Additionally, a key driver
of the Curetis’ core business will be OpGen’s existing Nasdaq
listing and thereby access to U.S. capital markets. This
opportunity provides access to a much broader and deeper pool of
capital within the U.S. market, ultimately giving the company a
larger platform to drive business and pipeline growth.
We are excited about the prospects for the
company, as we expect to be able to achieve more sustainable growth
combined than as separate entities. We anticipate multiple FDA
clearance opportunities and we strive to integrate our premier
bioinformatics solutions and databases. We will deploy our PCR
platforms such as Unyvero and Acuitas as well as our ARESdb and
Lighthouse knowledgebase and offer services and strategic
partnering opportunities for our next generation sequencing and
AI-powered prediction algorithms. Ultimately, the prospect of
having the ability to control our own destiny and steer our
proprietary platforms is exciting. This offers partnering,
commercial and financing opportunities that will likely provide
stockholders with attractive entry and exit opportunities.
In conclusion, on behalf of the Board, I thank
you for your unwavering support of the new OpGen. We remain
committed to our mission and to the hospitals and communities that
we serve. 2020 will be an exciting year as we continue to build the
business and deliver on our commitment to premier AI-powered
solutions to the AMR crisis.
Yours sincerely, William E. Rhodes Chairman of the Board, OpGen,
Inc. Board of Directors
About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we
are developing and commercializing molecular microbiology solutions
helping to guide clinicians with more rapid and actionable
information about life threatening infections to improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs. OpGen’s product
portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas
Lighthouse, and the ARES Technology Platform including ARESdb,
using NGS technology and AI-powered bioinformatics solutions for
antibiotic response prediction.
For more information, please visit
www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
the integration of OpGen with its acquired subsidiaries, Curetis
GmbH and Ares Genetics GmbH, the current business and strategic
initiatives of OpGen and general market conditions. 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, the rate of adoption of our
products and services by hospitals and other healthcare providers,
the realization of expected benefits of our business combination
transaction with Curetis GmbH, the success of our commercialization
efforts, the impact of COVID-19 on the Company’s operations,
financial results, and commercialization efforts as well as on
capital markets and general economic conditions, 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: Oliver Schacht President and CEO
InvestorRelations@opgen.com
OpGen Press Contact: Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact: Joe Green Edison
Group jgreen@edisongroup.com
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