Intellipharmaceutics International Inc. (IPCI)

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Toronto, Ontario, March 4, 2019 Intellipharmaceutics International Inc. (Nasdaq and TSX:IPCI) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that it has resubmitted its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for its Oxycodone ER product candidate.

The Company's NDA for an abuse-deterrent version of Oxycodone ER was initially accepted for filing by the FDA in February 2017. Intellipharmaceutics resubmitted the NDA in response to a Complete Response Letter (“CRL”) received from the FDA, which provided certain recommendations and requests for information. The FDA granted us an extension to February 28, 2019 to resubmit our NDA under section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act and the Company has now met this deadline.

There can be no assurance that Intellipharmaceutics will not be required to conduct further studies for Oxycodone ER, that the FDA will approve any of the Company's requested abuse-deterrent label claims or that the FDA will ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.







Over the past three fiscal years and up to February 28, 2019, we have raised approximately $36,095,962 in gross proceeds from the issuance of equity and convertible debt securities.




On January 28, 2019, we announced that we had received notice from the Nasdaq Panel extending the continued listing of our common shares until March 7, 2019, subject to certain conditions, while we work to regain compliance with Nasdaq’s requirements. Following the March 7, 2019 deadline, the Nasdaq Panel will determine whether a further extension period is warranted in the event we have not regained compliance. However, there can be no assurance that the Nasdaq Panel will grant such an extension. Moreover, there can be no assurance that we will be able to regain compliance with Nasdaq's requirements or, if we do, that we will be able to maintain compliance with all applicable requirements for continued listing on Nasdaq over the long term. The Nasdaq Panel's determination requires us to promptly notify Nasdaq of any significant events that occur during the extension period that may affect our compliance with Nasdaq requirements.

There is no assurance that the Company will be able to regain compliance with Nasdaq ’ s listing requirements, or if it does, that the Company will be able to maintain compliance with Nasdaq ’ s listing requirements. If we are unable to maintain compliance with Nasdaq ’ s continued listing requirements, our common shares may no longer be listed on Nasdaq or another U.S. national securities exchange and the liquidity and market price of our common shares may be adversely affected. If our common shares are delisted from Nasdaq, they may trade in the U.S. on the over-the-counter market, which is a less liquid market. In such case, our shareholders ’ ability to trade, or obtain quotations of the market value of, our common shares would be severely limited because of lower trading volumes and transaction delays. These factors could contribute to lower prices and larger spreads in the bid and ask prices for our securities. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities.