Enveric Biosciences Optimistic On Q4 And Full-Year Results: 'Psychedelic-Inspired' Meds For Future Growth

Nasdaq-listed psychedelics biotech Enveric Biosciences ENVB shared its financial results for the fourth quarter of 2023 and the fiscal year ended December 31, 2023, results showing:

• Cash in hand of $2,287,977 by December 31, 2023, as compared to the $17,723,884 held by December 31, 2022. 
• Yearly R&D expenses of $7.3 million, vs. the $8 million spent in 2022.
• Yearly general administrative (G&A) expenses of $8.9 million, vs. the $11.6 million spent in 2022. 
• Total yearly operating expenses of $16.4 million, vs. the $27.4 million spent in 2022.
• Yearly net cash used in operations totaled $14.1 million, vs. $17.1 million in 2022. 
• Quarterly net loss of $3.44 million (or $1.46 loss per share), vs. a net loss of $8.80 million (or $4.89 loss per share) for the comparative quarter of 2022.
• Yearly net loss of $17.3 million, vs. $18.5 million in 2022.
• On December 28, 2023, Enveric completed a warrant inducement transaction with two investors, repricing and exercising existing warrants and issuing new ones for gross cash proceeds of around $4.5 million (received by February 2024.)

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Pipeline Progression And Management Comments

In its pursuit of developing novel small molecules that induce neuroplasticity as potential alternative treatments for depression, anxiety and addiction disorders, the company is advancing two drug candidates: lead program, EB-003, a third-generation psychedelic-inspired New Chemical Entity (NCE) targeting difficult-to-treat mental health conditions; and EB-002 (formerly EB-373,) a second-generation psilocin prodrug targeting anxiety. 

While both EB-003 and EB-002 are at the pre-clinical development stage, the "expected next steps" for the former is filing a regulatory application to begin a first-in-human clinical trial in Australia and, for the latter, an Investigational New Drug (IND) application in the U.S. 

During the fiscal year, Enveric progressed preclinical development of EB-002 through toxicology and safety studies and selected EB-003 as the lead drug candidate from its next-generation EVM301 series, a period's highlight according to CEO Joseph Tucker.

"We believe EB-003 is a groundbreaking neuroplastogen drug candidate that offers the potential to treat severe mental health disorders without the hallucinogenic effect typically associated with psychedelic-based molecules," said Tucker, adding that widespread market acceptance of psychedelic-inspired drugs will ultimately be determined by the ability to administer such medications in an outpatient setting. 

"We believe minimizing the hallucinatory effect will be key to seizing this opportunity and was critical in our decision to select EB-003 as our lead product candidate of the EVM301 series. We now look forward to advancing preclinical activities in early 2024 in support of filing an IND for EB-003 as we seek to introduce a new treatment paradigm for depression and anxiety disorders," he concluded.

Also during 2023, the team reported discovering and characterizing over 1,000 synthesized psychedelic-inspired compounds, reportedly owing to "the acceleration" of the company's AI-backed platform directed to specific applications in mental health disorders management. Accordingly, Enveric further strengthened its IP portfolio, with ten new U.S.-issued patents.

As for expanded business development in 2023 and 2024, Enveric signed three non-binding term sheets toward the out-license of three classes of compounds for potential revenue of $200 million, pursuant to future development and sales milestone payments and execution fees.

The company also signed two non-binding term sheets for out-licensing cannabinoid conjugate compounds for pharmaceutical and non-pharmaceutical applications for treating joint diseases. This potential revenue could amount to $61 million.

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