ADDED
In addition, statements that we believe and similar statements reflect our beliefs and opinions on the relevant subject.
These risks include, but are not limited to, the following: We are substantially dependent on the success of our lead product candidate, PGN-EDODM1.
If we are unable to complete development of, obtain approval for and commercialize PGN-EDODM1 in a timely manner or at all, our business will be harmed.
We have incurred significant losses since our inception, have no products approved for sale and we expect to incur losses for the foreseeable future.
We have never generated revenue from product sales and may never achieve or maintain profitability.
If we are unable to raise substantial additional funding when needed, we could be forced to delay, scale back or discontinue our product development programs or future commercialization efforts.
We are early in our development efforts, having conducted only two Phase 1 and three Phase 2 clinical trials since our inception and as a result it will be years before we commercialize a product candidate, if ever.
If we are unable to advance our remaining clinical stage product candidate through clinical trials, obtain marketing approval and ultimately commercialize it, or experience significant delays in doing so, our business will be materially harmed.
Drug development is a lengthy and expensive process, and preclinical and clinical testing is uncertain as to the outcome.
We may encounter substantial delays in the commencement, enrollment or completion of our clinical trials and may never advance to clinical trials, or we may fail to demonstrate safety and effectiveness to the satisfaction of applicable regulatory authorities, which could prevent us from advancing or commercializing our product candidates on a timely basis, if at all.
REMOVED
In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject.
These risks include, but are not limited to, the following: We have incurred significant losses since our inception, have no products approved for sale and we expect to incur losses for the foreseeable future.
If we are unable to raise capital when needed, we could be forced to delay, scale back, or discontinue our product development programs or future commercialization efforts.
We have only completed a Phase 1 clinical trial and initiated Phase 2 clinical trials for our first product candidate, as well as initiated an additional Phase 1 clinical trial and more recently, a Phase 2 clinical trial of a second product candidate, and as a result it will be years before we commercialize a product candidate, if ever.
If we are unable to advance our product candidates through preclinical studies and clinical trials, obtain marketing approval and ultimately commercialize them, or experience significant delays in doing so, our business will be materially harmed.
Our business is highly dependent on the clinical advancement of our programs and modalities and is especially dependent on the success of our lead product candidates, PGN-EDO51 and PGN-EDODM1.
Delay or failure to advance programs or modalities, including PGN-EDO51 and PGN-EDODM1, including as a result of a clinical hold or other regulatory action, could adversely impact our business.
Preclinical and clinical development involves a lengthy and expensive process with an uncertain outcome, and the results of preclinical and clinical studies, including studies of PGN-EDO51, PGN-EDODM1 and other research candidates, are not necessarily predictive of the results of later preclinical studies and any clinical trials of our product candidates.
Our product candidates may not have favorable results in clinical trials, if any, or receive regulatory approval on a timely basis, if at all.
Substantial delays in the commencement, enrollment or completion of our clinical trials and advancement of our clinical trials, including as a result of clinical hold or other regulatory action, or failure to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities could prevent us from commercializing product candidates we determine to develop on a timely basis, if at all.