Item 1.01. Entry into a Material Definitive Agreement.
On
The CRADA, now co-signed by BARDA, provides the Company with access to
manufacturing capacity reserved by BARDA for fill-finish product to accelerate
the drug product manufacturing of lenzilumab. The initial agreement, originally
signed in
The foregoing summary of the CRADA does not purport to be complete and is
qualified in its entirety by reference to the full text of the CRADA, which will
be filed with the
A copy of the Company's press release relating to the CRADA is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 8.01. Other Events.
As previously disclosed, the Company has been continuing to advance its efforts
to submit an application for EUA for lenzilumab, with potential product launch
subject to EUA being granted as early as the second quarter of 2021, in the
event data from the Phase 3 clinical trial are favorable. The Company currently
anticipates that top-line data from the trial will be available in the first
quarter of 2021. To support the potential launch of lenzilumab under an EUA, the
Company has entered into agreements with several organizations for clinical
trial services, contract manufacturing services and commercialization services.
The agreements currently in effect commit the Company to spend approximately
The Company is working with its existing contract manufacturing organizations and with additional contract manufacturing organizations to bolster its ability to supply lenzilumab in the event of receipt of EUA. Most of these manufacturing agreements, like the ones currently in place, are expected to require payment of upfront fees upon execution and further payments against performance of the manufacturing services to be provided, often over a lengthy performance period. Given the competitive environment, it is not possible for the Company to estimate the aggregate amount of these potential future payments or the timing in which they may be made. If the COVID-19 clinical study is successful and an EUA is granted in the second quarter of 2021, the Company expects to be able to satisfy the bulk of the cash requirements associated with its manufacturing commitments from revenues from the commercial sale of lenzilumab, supplemented as necessary with proceeds from the sale of our equity securities; the incurrence of debt; upfront and milestone payments from licensees; and government funding or financial support, if offered.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements.
Forward-looking statements reflect management's current knowledge, assumptions,
judgment and expectations regarding future performance or events. Although
management believes that the expectations reflected in such statements are
reasonable, they give no assurance that such expectations will prove to be
correct and you should be aware that actual events or results may differ
materially from those contained in the forward-looking statements. Words such as
"will," "expect," "intend," "plan," "potential," "possible," "goals,"
"accelerate," "continue," and similar expressions identify forward-looking
statements, including, without limitation, statements regarding
All forward-looking statements are expressly qualified in their entirety by this
cautionary notice. You should not place undue reliance on any forward-looking
statements, which speak only as of the date of this filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
Exhibit No. Exhibit Description
99.1 Press release, dated
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