Enveric Biosciences Trims Losses, Eyes Key Drug Approval For Difficult-To-Treat Mental Health Disorders

Psychedelics biotech company Enveric Biosciences ENVB provided a corporate update and reported financial results for the third quarter ended Sept. 30, 2024.

"The third quarter of 2024 was highlighted by important progress in the development of EB-003, our neuroplastogenic molecule that is designed to address difficult-to-treat mental health disorders without inducing the hallucinogenic effect common to N,N-Dimethyltryptamine (DMT) and related analogs," stated Joseph Tucker, Ph.D., director and CEO of Enveric. "Among the key achievements, data confirmed that EB-003 has the potential to be delivered via oral administration and penetrate the brain at levels expected to elicit the desired therapeutic effect. Additionally, preclinical safety and pharmacology studies confirmed that EB-003 targets desired serotonergic receptors while minimizing potentially harmful, off-target interactions common to serotonin-like drug compounds. These are clear differentiators for EB-003, which we believe will add to its value potential."

Tucker says that "drug technologies that minimize or eliminate the hallucinogenic effect in molecules targeting the 5-HT2A receptor have the potential to become the gold standard in one or more neuropsychiatric indications." The company plans to submit an EB-003 Investigational New Drug (IND) application to the U.S. Food and Drug Administration in the second half of 2025.

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Q3 Financial Highlights

Net loss attributable to stockholders was $2.1 million, including $500,000 in net non-cash expense, with a basic and diluted loss per share of $0.24, as compared to a net loss of $2.8 million, including $0.2 million in net non-cash income, with a basic and diluted loss per share of $1.30 for the quarter ended Sept. 30, 2023.

Total operating expenses amounted to $2.08 million, compared to $3.45 million in the same period last year.

At the end of the reporting period on Sept. 30, 2024, Enveric had cash-on-hand of $3.1 million, and accumulated deficit of $102.92 million.

In the quarterly report filed with the SEC, Enveric noted that "further losses are anticipated in the development of its business. Being a research and development company, since inception, the company has not yet generated revenue and the company has incurred continuing losses from its operations. The company's operations have been funded principally through the issuance of equity. These factors raise substantial doubt about the company's ability to continue as a going concern for a period of one year from the issuance of these unaudited condensed consolidated financial statements."

To continue as a going concern, Enveric needs to raise additional capital.

The company had cash-on-hand of $3.1 million for the quarter ended September 30, 2024.

Corporate, Product and Business Development Highlights

• Confirmed oral bioavailability and significant brain exposure in preclinical studies of EB-003, supporting expedited development with IND filing and first patient dosed expected in 2025
• Announced positive results from preclinical safety and pharmacology studies of EB-003, confirming the drug's selective activity with desired serotonergic neuroreceptors and ability to minimize potential adverse cardiovascular and CNS events
• Presented foundational research involving EB-003 at the 7th Neuropsychiatric Drug Summit and the European Behavioral Pharmacology Society Biennial Workshop
• Strengthened intellectual property estate for EVM301 portfolio and announced the issuance of five additional U.S. patents
• Executed licensing agreement with Aries Science & Technology to clinically develop and market Enveric's patented product for radiation dermatitis

Price Action

Enveric Biosciences shares closed Friday market session 8.06% lower at 37 cents per share.

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