We currently have no products approved
for sale and have invested a significant portion of our efforts and financial resources in the development of crenezumab, anti-Tau
antibody, ACI-24 for AD and DS, ACI-35, Morphomer Tau and Tau-PET Imaging tracer, all of which are in clinical development. Our
ability to generate product revenues, which we do not expect will occur for at least the next several years, if ever, will depend
heavily on successful clinical development, obtaining regulatory approval and eventual commercialization of these product candidates.
In this regard, we rely heavily on our collaboration partners for clinical development of certain of our product candidates, and
they may choose to discontinue the clinical development process in certain cases. For example, in January 2019, Roche, the parent
of our collaboration partner, discontinued the CREAD 1 and CREAD 2 Phase III studies of crenezumab in people with prodromal to
mild sporadic Alzheimer’s disease (AD). The decision came after an interim analysis conducted by the Independent Data Monitoring
Committee, or IDMC. The IDMC analysis indicated that crenezumab was unlikely to meet its primary endpoint of change from baseline
in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. However, the Phase 2 development of crenezumab continues in a preventive
trial of cognitively healthy individuals in Colombia with a risk of developing AD. In addition, we currently generate no revenues
from sales of any drugs or diagnostics, and we may never be able to develop or commercialize a marketable drug or diagnostic. The
success of our current and future product candidates will depend on several factors, including the following:
||completing clinical studies that demonstrate the efficacy, safety and clinical utility of our product candidates;|
||receiving marketing approvals from applicable regulatory authorities;|
||establishing commercial manufacturing capabilities;|
||launching commercial sales, marketing and distribution operations;|
||acceptance of our product candidates by patients, the medical community and third-party payors;|
||a continued acceptable safety profile following approval;|
||competing effectively with other therapies or diagnostic approaches; and|
||qualifying for, obtaining, maintaining, enforcing and defending our intellectual property rights and claims and not infringing on third parties’ intellectual property rights.|
If we or our collaboration partners do
not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to
successfully commercialize our current or future product candidates, which would materially adversely affect our business, financial
condition and results of operations.
Results of early clinical studies may not be
predictive of future study results.
Positive or timely results from preclinical
or early stage studies do not ensure positive or timely results in late stage clinical studies or product approval by the U.S.
Food and Drug Administration, or the FDA, the European Medicines Agency, or the EMA, or comparable foreign regulatory authorities.
Products that show positive preclinical or early clinical results may not show sufficient safety or efficacy in later stage clinical
studies and therefore may fail to obtain regulatory approvals. In addition, preclinical and clinical data are often susceptible
to varying interpretations and analyses. Many companies that believed their product candidates performed satisfactorily in preclinical
and clinical studies have nonetheless failed to obtain marketing approval for the product candidates. The FDA, the EMA and comparable
foreign regulatory authorities have substantial discretion in the approval process and in determining when or whether regulatory
approval will be obtained for any of our product candidates. Even if we believe the data collected from clinical studies of our
product candidates are promising, such data may not be sufficient to support approval by the FDA, the EMA or any other regulatory
In some instances, there can be significant
variability in safety and/or efficacy results between different studies of the same product candidate due to numerous factors,
including changes in study procedures set forth in protocols, differences in the size and type of the patient populations, adherence
to the dosing regimen and other study protocols and the rate of dropout among clinical study participants. In the case of our later
stage clinical product candidates, results may differ in general on the basis of the larger number of clinical study sites and
additional countries and languages involved in these clinical studies.