Item 1.01 - Entry into a Material Definitive Agreement.
On
The amendment to the Agreement extends the
AD Pharma may terminate the Amended Agreement at any time. Additionally, if the NDA for LTX-03 is not accepted by the FDA by the NDA Acceptance Date, AD Pharma may terminate the Amended Agreement and take ownership of the intellectual property rights of LTX-03 from the Company. Should AD Pharma choose not to exercise this option to terminate the Amended Agreement and the NDA for LTX-03 is subsequently accepted by the FDA, such option to terminate the Amended Agreement expires.
The inclusion of a description of the Amended Agreement with AD Pharma under Item 1.01 of this Current Report on Form 8-K shall not be deemed an acknowledgment that the Amended Agreement is a material agreement not made, or deemed not to be made, in the ordinary course of our business.
Item 1.01 - Entry into a Material Definitive Agreement.
On
The funding provided by AD Pharma will be used for operations over the course of
the next month. There can be no assurance we will be successful in receiving
additional financing. In the absence of the receipt of additional financing by
end of
The inclusion of a description of the Note under Item 1.01 of this Current Report on Form 8-K shall not be deemed an acknowledgement that the Note is a material agreement not made, or deemed not to be made, in the ordinary course of our business.
At
Item 2.01 - Completion of Acquisition or Disposition of Assets
The contents of Item 1.01 are incorporated herein by reference.
2
Item 2.03 - Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant
The contents of Item 1.01 are incorporated herein by reference.
Forward-Looking Statements
Statements in this Current Report constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements.
Forward-looking statements may include, but are not limited to:
· our ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITx and IMPEDE technologies; · whether we will receive FDA acceptance for an NDA for LTX-03 by the target date, currentlyJune 30, 2023 ;
· whether our licensees will terminate the license prior to commercialization;
· the expected results of clinical studies relating to LTX-03 or any successor product candidate, the date by which such studies will complete and the results will be available and whether any product candidate will ultimately receive FDA approval; · the ability of LTX-03 single tablets to achieve bioequivalence or to demonstrate efficacy in a clinical study; · whether our licensing partners will develop any additional products and utilize Acura for such development; · whether LIMITx will retard the release of opioid active ingredients as dose levels increase; · whether the extent to which products formulated with the LIMITx technology mitigate respiratory depression risk will be determined sufficient by the FDA; · our and our licensee's ability to successfully launch and commercialize our products and technologies; · our and our licensee's ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies; · the market acceptance of, timing of commercial launch and competitive environment for any of our products; · our ability to develop and enter into additional license agreements for our product candidates using our technologies; · the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties; · the ability of our patents to protect our products from generic competition and our ability to protect and enforce our patent rights in any paragraph IV patent infringement litigation; · the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support an NDA and FDA approval of our product candidates;
· changes in regulatory requirements;
· adverse safety findings relating to our commercialized products or product
candidates in development;
· whether or when we are able to obtain FDA approval of labeling for our
product candidates for the proposed indications and whether we will be able
to promote the features of our technologies; and
· whether our product candidates will ultimately perform as intended in
commercial settings.
In some cases, you can identify forward- looking statements by terms such as
"may," "will", "should," "could," "would," "expects," "plans," "anticipates,"
"believes," "estimates," "indicates", "projects," "predicts," "potential" and
similar expressions intended to identify forward-looking statements. These
statements reflect our current views with respect to future events and are based
on assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these forward-looking
statements. We discuss many of these risks in greater detail in our filings with
the
Item 9.01 - Financial Statements and Exhibits
Exhibit Number Description
99.1 Amendment #4 datedNovember 10, 2022 to License, Development and Commercialization Agreement withAbuse Deterrent Pharma, LLC 99.2 Amended Consolidated and Restated Secured Promissory Note datedNovember 10, 2022 assigned toAbuse Deterrent Pharma, LLC 99.3 Amendment #5 datedDecember 15, 2022 to License, Development and Commercialization Agreement withAbuse Deterrent Pharma, LLC 104 Cover Page Interactive Data File (embedded as Inline XBRL document) 3
© Edgar Online, source