Item 1.01. Entry into a Material Definitive Agreement.
On
The Company made certain customary representations, warranties and covenants
concerning the Company and the registration statement in the Underwriting
Agreement and also agreed to indemnify the Underwriters against certain
liabilities, including liabilities under the Securities Act of 1933, as amended
(the "Securities Act"). The Offering was made pursuant to the Company's
effective shelf registration statement on Form S-3ASR (File No. 333-238182),
including the prospectus dated
The foregoing description of certain terms of the Underwriting Agreement and the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Underwriting Agreement, which is attached as Exhibit 1.1 hereto and is incorporated by reference herein. A copy of the opinion of Mourant Ozannes, relating to the legality of the ordinary shares underlying the ADSs being sold by the Selling Shareholders, is filed as Exhibit 5.1 hereto and is incorporated by reference herein.
As previously disclosed, on
On
The foregoing description of the terms of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 8.01. Other Events
On
In connection with the Offering, the Company included the following risk factor
in the prospectus supplement, which also supplements the risk factors described
under "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for
the year ended
Risks Related to Clinical Development and Regulatory Approval of Our Drugs and Drug Candidates
Preliminary data and results from an interim analysis from our clinical trials may be updated as more patient data become available and are subject to audit and verification procedures that could result in material changes in the data. The interim results of our clinical trials may not be predictive of future results. These data may or may not be sufficient to support regulatory submissions or approvals.
From time to time, we may publish or receive preliminary or interim analysis data from our clinical trials, such as the interim analysis data that we recently reported from the RATIONALE 303 trial of our anti- PD-1 antibody tislelizumab in non-small cell lung cancer. Clinical data may change over time from the preliminary and interim data from our clinical trials when more patient data become available. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data as of the time we publish or receive preliminary or interim data. Preliminary or interim data from our clinical trials are not necessarily predictive of final results. Interim and preliminary data remain subject to audit and verification procedures that may result in additional data being materially different from the preliminary or interim data we previously published or received. As a result, preliminary and interim data should be viewed with caution until the data are more mature and/or until final data are available. Material adverse changes in subsequent data compared to the preliminary or interim data could significantly harm our business prospects. Moreover, preliminary and interim data are subject to the risk that one or more of the clinical outcomes may materially change as more patient data become available when patients mature on study, patient enrolment continues, or as other ongoing or future clinical trials with a drug candidate further develop. The results of clinical trials may not be predictive of future results.
Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of interim or preliminary data differently or request additional data from us, any of which could have a material adverse effect on the value of the particular program, the approval or commercialization prospects of the particular drug candidate or drug and our business in general.
In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is typically only the results from the primary analysis and key secondary analyses, which are only a portion of the extensive information generated from the study or clinical trial, and such disclosure may not include all information that investors may consider material. Any information we determine not to disclose may ultimately be or become significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, drug candidate or our business. If the interim or preliminary data that we report are not supported by subsequent data, or if others, including regulatory authorities, disagree with the conclusions that we have reached with respect to such interim or preliminary data, our ability to obtain approval for, and commercialize, the drug candidate supported by the data may be harmed, which could have a material adverse effect on our business, operating
results, prospects or financial condition.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 1.1* Underwriting Agreement, dated as ofDecember 1, 2020 , by and among the Company, the Selling Shareholders andGoldman Sachs & Co. LLC , as the representative of the several underwriters listed on Schedule I thereto 5.1 Opinion of Mourant Ozannes Amendment No. 1 to Registration Rights Agreement, dated December 10.1 1, 2020, between the Company and the Investors 23.1 Consent of Mourant Ozannes (included in Exhibit 5.1) 99.1 Press release announcing the launch of the Offering, datedDecember 1, 2020 99.2 Press release announcing the pricing of the Offering, datedDecember 1, 2020 The cover page from this Current Report on Form 8-K, formatted in 104 Inline XBRL * Non-material schedules and exhibits have been omitted pursuant to Item 1.01 of Form 8-K. The Registrant hereby undertakes to furnish supplementally copies of any of the omitted schedules and exhibits upon request by theSEC . Forward Looking Statements
This Current Report on Form 8-K and certain of the materials furnished or filed herewith contain forward-looking information about the Company within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein and therein which do not describe historical facts, including, among others, statements regarding the expected timing for the closing of the Offering; the Company's expectations with respect to the Selling Shareholders granting the underwriters a 30-day option to purchase additional ADSs or the underwriters' exercise of the same; and those statements in the materials furnished herewith that are designated as "forward-looking statements" are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others, (1) the possibility that the
closing conditions set forth in the Underwriting Agreement will not be met and
that the parties will be unable to consummate the proposed transaction on the
anticipated terms or at all; (2) that the cost of the transaction to the Company
will be more than planned; (3) that the Company, the Selling Shareholders or the
Underwriters will fail to fully perform their respective obligations under the
Underwriting Agreement; and (4) other risks identified in the Company's
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