Item 7.01 - Regulation FD Disclosure.
In
On
Based on the Interim Analysis, the combination of Vicineum and durvalumab has been generally well-tolerated with no new safety signals emerging (no Grade 4 or 5 treatment-related adverse events) and has a similar safety profile compared to both agents used individually. The Interim Analysis also indicated a 3-month complete response rate of 42% (5/12) and a 12-month complete response rate of 17% (2/12).
The information furnished in this Item 7.01, including the presentation attached as Exhibit 99.1, shall not be deemed to be "filed" for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of such section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, statements regarding the belief that Vicineum works via a
dual mechanism of action that kills cancer cells, the safety, efficacy and
tolerability of the combination of Vicineum and durvalumab based on the NCI's
Interim Analysis, which are based on the Company's current expectations and
inherently involve significant risks and uncertainties. The Company's actual
results and the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of these risks and uncertainties,
including the risk that the hypothesis regarding Vicineum's dual mechanism of
action may fail after further investigation, the risk that the Interim Analysis
may not be predictive of the success of later clinical trials, the Interim
Analysis does not necessarily predict final results, clinical data and analyses
are often susceptible to varying interpretations, the clinical trial process may
fail to demonstrate that the combination of Vicineum and durvalumab is both safe
and effective for their intended uses, the combination of Vicineum and
durvalumab for the treatment of BCG-unresponsive NMIBC may cause undesirable
side effects and serious adverse events or have other properties that could
delay or halt clinical trials, among other risks and uncertainties. A further
description of the risks and uncertainties relating to the business of the
Company is contained in the Company's most recent annual report on Form 10-K and
the Company's quarterly reports on Form 10-Q, as well as any amendments thereto
reflected in subsequent filings with the
Item 9.01 - Financial Statements and Exhibits. (d) Exhibits.
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Exhibit No. Description 99.1 NCI Presentation Made at the 2021American Urological Association Conference onSeptember 10, 2021 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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