Item 2.05 Costs Associated with Exit or Disposal Activities.
On
Should the Company proceed with the proposal, the Company expects to reduce
annual operating expenses in 2022 by approximately
A copy of the press release announcing the proposed consolidation plan is provided as Exhibit 99.1 of this Current Report, and is incorporated into this Item 2.05 by reference.
Statements contained under this Item 2.05, including Exhibit 99.1, regarding
matters that are not historical facts are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. Because
such statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such forward-looking
statements. These forward-looking statements include, but are not limited to,
express or implied statements regarding the therapeutic potential of gavo-cel
and the Company's emerging solid tumor pipeline, expectations regarding
increased demand for the Company's product candidate trials, the proposed
consolidation of manufacturing in the US and closure of the manufacturing suite
in
Any forward-looking statements are based on management's current expectations of
future events and are subject to a number of risks and uncertainties that could
cause actual results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. Risks that contribute to the
uncertain nature of the forward-looking statements include, without limitation:
uncertainties inherent in clinical studies and in the availability and timing of
data from ongoing clinical studies; whether interim results from a clinical
trial will be predictive of the final results of a trial; the possibility that
positive results from preclinical studies and correlative studies may not
necessarily be predictive of the results of the Company's planned clinical
trials; whether results from preclinical studies or earlier clinical studies
will be predictive of the results of future trials; the expected timing of
submissions for regulatory approval or review by governmental authorities,
including review under accelerated approval processes; orphan drug designation
eligibility; regulatory approvals to conduct trials or to market products; the
Company's ability to maintain sufficient manufacturing capabilities to support
its research, development and commercialization efforts, including the Company's
ability to secure additional manufacturing facilities; whether the Company's
cash resources will be sufficient to fund the Company foreseeable and
unforeseeable operating expenses and capital expenditure requirements, the
impact of the COVID-19 pandemic on the Company's ongoing operations; and other
risks set forth under the caption "Risk Factors" in the Company's most recent
Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its
other filings with the
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press release datedNovember 1, 2021 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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