allem Optimismus den James Noble verbreitet um den zukünftigen Eignern (Kapitalgebern) Adaptimmune schmackhaft zu machen, sollte man sich die Liste der Risiken zuerst näher betrachten. (aus dem Wertpapierprospekt Adaptimmune)
"Risks Associated With Our Business
Our business is subject to a number of risks of which you should be aware of before making an
investment decision. These risks are discussed more fully in the ‘‘Risk Factors’’ section of this
prospectus immediately following this prospectus summary. These risks include the following:
• We are a clinical-stage biopharmaceutical company with no commercial products and have
incurred net losses since our inception. We expect to continue to incur losses for the
foreseeable future and may never achieve or maintain profitability.
• We do not have adequate funding to complete development of our TCR therapeutic
candidates and may be unable to access additional capital on reasonable terms, or at all, to
complete development and commercialization of our TCR therapeutic candidates.
• T-cell therapy represents a novel approach to cancer treatment that creates significant
challenges for us including those related to regulatory and manufacturing processes.
• Our T-cell therapy is a type of cell therapy that uses gene therapy technology which creates
significant challenges in terms of the further development, regulatory approval,
administration and manufacture of our TCR therapeutic candidates.
• We are subject to a complex regulatory regime that is subject to change and may fail to
obtain regulatory approval for any of our TCR therapeutic candidates.
• We may not be able to submit INDs to commence additional clinical trials on the timelines
we expect, and even if we are able to, the FDA may not permit us to proceed with the
clinical trials at all or in the timeframes we expect.
• Our business is highly dependent on our NY-ESO TCR therapeutic candidate, which will
require significant additional clinical testing before we can seek regulatory approval and
potentially achieve commercial sales.
• We also depend on the success of our MAGE A-10 TCR therapeutic candidate, which is still
in preclinical development and may eventually prove unsuitable for patient treatment.
• Our TCR therapeutic candidates may have undesirable side effects, including neutropenia,
which is an abnormally low level of neutrophils, a type of white blood cell, Cytokine-Release
Syndrome, which is a set of symptoms resulting from activation of immune cells, including
5
fever, nausea, chills, hypotension, tachycardia and dyspnea, and even death, or have other
properties that could halt their clinical development, prevent their regulatory approval, limit
their commercial potential, or result in significant negative consequences.
• Our clinical trials may fail to demonstrate adequately the safety and efficacy of any of our
TCR therapeutic candidates, which would prevent or delay regulatory approval and
commercialization.
• Our TCR therapeutic candidates may not gain market acceptance, in which case we may not
be able to generate product revenues.
• We may not be able to obtain adequate protection for the intellectual property covering our
TCR therapeutic candidates or develop and commercialize these product candidates without
infringing on the intellectual property rights of third parties.
• We rely heavily on GSK for our NY-ESO TCR therapeutic candidate clinical program.
• We have a shared development history with Immunocore Limited, or Immunocore, and share
ownership of certain core intellectual property rights with Immunocore. If we fail to maintain
our relationship with Immunocore, we could lose important target identification resources
that could result in delays in our ability to identify new TCR therapeutic candidates or
compromise the sharing of our underlying core intellectual property.
• We rely on contract manufacturers and contract research organizations over which we have
limited control.
• We expect to face intense competition, often from companies with greater resources and
experience than we have. In addition, Immunocore also develops affinity-enhanced TCRs.
There is a risk that both companies could develop products or therapies that target the same
peptide and compete directly with each other.
• Our future growth and ability to compete depend on retaining our key personnel and
recruiting additional qualified personnel."
interessant der Hinweis auf Immunocore.
wie würde wohl die Risikoliste bei einem IPO der Medigene Immuntherapies aussehen (zB. Verträge mit Trianta)?
Fazit: es gibt auch im Biotechsektor keine (Milch) Quoten mehr und die Kuh kann gemolken werden...naja
|
Thread abonnieren
