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Interview
conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – June
11, 2012
CEOCFO:
Mr. Klingmann, would you give us an overview and focus of Omnia Molecular?
Mr.
Klingmann:
Omnia designs and develops novel antibiotics. We are targeting
healthcare-acquired infections in the clinic- those which are difficult to
treat with existing antibiotics due to the evolution of resistance.
In the USA,
hospital-acquired infections result in 8 million additional hospital days
and nearly 90,000 deaths per year. These infections also often require the
surgical removal of infected tissue and amputations. In addition to the
immeasurable toll in terms of pain and suffering of the patients, the direct
costs to the U.S. healthcare system have been estimated to lie between $21B
to $34B per year.
We develop antibiotics using
our proprietary molecular biology platform to guide the design of small
molecules that selectively inhibit the protein synthesis of the pathogen.
Our business model is to
collaborate with pharma companies in the pre-clinical stage and to
out-license the resulting candidates at preclinical proof-of-concept.
CEOCFO: Would you please explain your
technology and what is different about it?
Mr.
Klingmann:
The traditional approach to antibiotic development has been to screen
a large chemical library against a pathogen target. Even with a hit rate
well below 1%, high-throughput screening will deliver relatively large
number of hits. Then begins the time-consuming task of differentiating, for
each hit, between selectivity and general toxicity. Sometimes, you have to
first confirm or even characterize the actual compounds themselves, because
your library probably contains mixtures. This is especially true of natural
compound libraries. Assuming you understand the chemistry, you will need to
investigate the mechanism of action in order to optimize the compounds. So-
its a very costly and time consuming process with a poor success rate, which
is reflected by the fact that there have been few novel antibiotics
approved.
In contrast, are using our
biotech platform to design small molecular entities against a known target
and mechanism of action. We use the multi- parametric information delivered
by our biotech platform to optimize the activity of these molecules. It is
this systematic, iterave process of optimization that allows us to
accelerate the preclinical phase of development. The platform allows us to
assay in human cells, so we are therefore are able to gain
structure-activity knowledge on a range of important parameters such as
ability to cross membranes, stability in the cytoplasm, and most
importantly, selectivity for the bacterial target. Our platform therefore
delivers indicators of human safety and efficacy from the very beginning of
pre-clinical development.
Omnia´s platform combined
with our target-focused design-based approach therefore allows us to
significantly reduce pre-clinical development time and deliver pre-clinical
candidates in a more systematic and predictable manner.
CEOCFO:
Would you tell us about your current projects?
Mr. Klingmann: Most recently, we signed
collaboration with the Open Lab of Glaxo Smithkline, to apply our technology
towards the effort of combating multi-drug resistant tuberculosis. We are
working with known inhibitors from the GSK library. In the spirit of the
Open Lab lead compounds resulting from the project will be available for
other partners to develop them further and into clinic.
Our main project is our
in-house program to develop inhibitors against the “ESKAPE” pathogens. These
are the bacteria responsible for the majority of the health care associated
infections.
We have filed a patent this
year to protect the chemical space of this program and intend to conclude a
co-development deal with a pharma industry partner on the strength of
pre-clinical efficacy data, which in the case of anti-biotics, is highly
predictive of success in the clinic.
I should also mention- it is a bit preliminary, but we also have a promising
early-stage anti-fungal project, which began as a European grant program. We
have some good results, some good hits and are in a confidential discussions
with a major pharmaceutical company right now on how best to take this
program further.
CEOCEO: What part of your process is
patented?
Mr.
Klingmann:
We have patented our molecular biology platform and methodology. This
platform enables us to test inhibitors of the pathogenic target within human
cells. There are, of course, also many trade secrets within the company in
terms of being able to create, sustain, and manipulate these cells. Our
target is an enzyme responsible for translating the genome of the pathogen.
There is just a great deal of knowledge necessary to be able to work in this
space and we are fortunate that the founder of Omnia is one of the world’s
experts on this family of enzymes.
CEOCFO: Development is always expensive;
is Omnia Molecular funded well enough to continue on until you get the
desired results?
Mr.
Klingmann:
We have a business model which allows us to generate grant and partnering
income which reduces the amount of dilutive capital that we need to raise.
We successfully closed an initial funding round in 2010 and we intend to
raise another round later this year to finance the development of our ESKAPE
program to proof-of-concept.
CEOCFO:
What do you see ahead and how do you internationalize the business?
Mr.
Klingmann:
That is part of our challenge right now. Although we have roots in the USA,
Omnia is based in Spain and we are a bit off-the-radar because of it. But we
are quite fortunate to have access to world-class facilities and expertise
in the Barcelona Biocluster. We enjoy a highly competitive cost base for our
molecular biology and animal facilities compared to the Boston or the San
Francisco Bay clusters.
The disadvantage has been
that venture capital and also some of the major pharmas do not typically
look to Spain for their biotech deal making. We have therefore been very
active in going out to them and we have been quite successful in doing that.
We are, however, also exploring how to best re-establish our presence in the
USA in the context of our fundraising efforts and access to NIAID grants.
CEOCFO:
Is the medical community paying attention and are people that should know
about Omnia, aware?
Mr.
Klingmann:
Within the European context, there has been a great deal of concern about
the emergence of multi-resistance. Spain and the other Mediterranean
countries have been particularly affected in the clinical setting. This has
resulted in the creation of a number of European grant programs in which we
are involved. So yes, the European community is aware of Omnia and we have
been quite successful with these grant projects.
The public financial
situation in Spain, however, is not as strong as the financing situation in
the US. There is simply no European equivalent to the National Institutes of
Health in terms of the sheer volume of grants in the area of infectious
disease through the NIAID.
CEOCFO: Why should investors consider
Omnia today and what sets you apart?
Mr.
Klingmann:
We operate to serve a large unmet medical need, in a market that has
expanded each time a new antibiotic has been introduced to the clinic.
Products such as Cubicin are approaching $1B in annual sales. Pharmaceutical
companies are attracted by the commercial opportunity and recognize their
obligation to meet the medical need, but most no longer have an anti-infectives
pipeline. That fact drives co-development and partnering opportunities for
companies such as Omnia. The recent Rib-X deal is a good example. Last year,
the company signed a pre-clinical co-development deal with Sanofi with a $19
million upfront, $86 million in development and regulatory milestones on a
per product basis and total deal value potentially worth $772 million. We
believe that Omnia has the potential to attract a comparable level of
interest in our ESKAPE program at pre-clinical proof-of-concept stage
thereby providing investors with a substantial return on their investment
within a predictable time-frame.
CEOCFO: What should people take away
from reading about Omnia?
Mr. Klingmann:
Omnia Molecular leverages its proprietary biotech platform to design and
develop novel anti-infectives targeted at difficult-to-treat infections.
Omnia’s competitive advantage is to shorten the pre-clinical phase of
anti-biotic development and reduce risk for the clinical phase. Recent deals
in this space have demonstrated the potential for a significant return to
investors at the end of the pre-clinical stage. Omnia has the technology,
people and programs in place to secure and manage such co-development
alliances.
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