Enveric Biosciences Says It Needs More Money To Get Past 2023

After the market closed on Monday, Enveric Biosciences, Inc. (NASDAQ: ENVB)  reported financial results for the fourth quarter and year ended December 31, 2022. Enveric does not have the revenue to report at this time.

The company reported a comprehensive net loss of $19.3 million for the year 2022, including $2.4 million in net non-cash expenses, with a basic and diluted loss per share of $13.00, as compared to a comprehensive net loss of $48.8 million with basic and diluted loss per share of $103.69 per share for 2021. The net cash used in operations for 2022, was $17.1 million consisting of an $18.5 million net loss, adjusted by a net of $1.5 million in non-cash expenses and changes in asset and liability balances of $0.2 million. The company lost $27 million in its 2022 operations.

Running Out of Cash

As of December 31, 2022, the company had cash and cash equivalents of $17.7 million and working capital of $14.4 million. It has an accumulated deficit of $79 million. Enveric also reported in its annual filing that the company is a going concern unless it can raise more capital. The company said it has enough cash to make it to the end of 2023, but not beyond that. The filing stated, “If we are not able to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our consolidated financial statements and/or seek protection under federal bankruptcy law, and it is likely that holders of our common stock and holders of securities convertible into our common stock will lose all of their investment.”

Recently the company announced that it had entered into an agreement with Avance Clinical, an Australia-based contract research organization (CRO) with US operations, for its planned Phase 1 clinical trial of EB-373, the company’s lead candidate targeting the treatment of anxiety disorders. EB-373, is a New Chemical Entity (NCE), designed as a next-generation proprietary psilocin prodrug and developed leveraging its Psybrary drug discovery platform to target anxiety disorders. The Phase 1 clinical trial is expected to initiate in the fourth quarter of 2023.

“Enveric is a transformed company; 2022 was a year of considerable accomplishments, and we are now poised for an active, productive and exciting 2023 as we strive to bring a new approach to solving the mental health challenges that face our society,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “In early 2023, we announced the establishment of our Australia-based subsidiary, Enveric Therapeutics Pty. Ltd, and we are rapidly preparing to initiate the planned Phase 1 trial of EB-373. Additionally, we are pleased to be working with Avance Clinical and are eager to benefit from the CRO’s proven expertise and experience managing early-stage clinical programs in Australia.”

Dr. Tucker continued: “Conducting the initial development of EB-373 in Australia enables us to leverage key clinical, regulatory and financial opportunities that the Australian government and the Therapeutic Goods Administration (TGA) have implemented to empower biotechnology companies to execute robust yet highly efficient clinical studies, particularly those advancing psychedelic-derived compounds. We now look forward to expeditiously advancing the Phase 1 clinical trial of EB-373 towards a potential topline data readout by early 2024. Our Australian subsidiary also gives Enveric an operational foothold in Australia, which we see as an ideal location to advance the development of additional future pipeline candidates generated from our EVM201 and EVM301 Series.”

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