Item 8.01. Other Events.
On
Under the collaboration and license agreement with Novartis, Aduro is continuing to enroll the Phase 2 clinical trial of ADU-S100 in combination with KEYTRUDA® (pembrolizumab), an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), with interim data to be presented in the second half of 2020. Aduro is also preparing to initiate a clinical trial of ADU-S100 as an intravesical monotherapy for non-muscle invasive bladder cancer (NMIBC) in the second half of 2020. The HNSCC and NMIBC studies are being solely funded by Aduro. Under the terms of the collaboration and license agreement between Novartis and Aduro, if Novartis opts out of funding an early stage clinical trial and the product progresses into a pivotal clinical trial, then both Aduro and Novartis would be required to fund and participate in the pivotal clinical trial, and Novartis may have certain reimbursement obligations for prior development expenses for the early stage clinical trial.
The collaboration and license agreement between Novartis and Aduro otherwise
remains in effect, and both parties continue to jointly pursue
Special Note on Forward-Looking Statements
This current report on Form 8-K ("Current Report") contains forward-looking
statements for purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include statements
regarding our intentions or current expectations concerning, among other things,
the potential for our therapies, the progress of our clinical programs,
including the timing of initiation of clinical trials and the timing for
presentation of clinical data, and funding for future development activities. In
some cases, you can identify these statements by forward-looking words such as
"may," "will," "continue," "anticipate," "intend," "could," "project," "expect"
or the negative or plural of these words or similar expressions. Forward-looking
statements are not guarantees of future performance and are subject to risks and
uncertainties that could cause actual results and events to differ materially
from those anticipated, including, but not limited to, early or preliminary
clinical trial results may not be predictive of future results, our history of
net operating losses and uncertainty regarding our ability to achieve
profitability, our ability to develop and commercialize our product candidates,
our ability to use and expand our technologies to build a pipeline of product
candidates, our ability to obtain and maintain regulatory approval of our
product candidates, our ability to operate in a competitive industry and compete
successfully against competitors that have greater resources than we do, our
reliance on third parties, and our ability to obtain and adequately protect
intellectual property rights for our product candidates. We discuss many of
these risks in greater detail under the heading "Risk Factors" contained in our
quarterly report on Form 10-Q for the quarter ended
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