On March 26, 2024 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, reported a corporate update and provided financial results for the fourth quarter of 2023 and fiscal year ended December 31, 2023 (Press release, Enveric Biosciences, MAR 26, 2024, View Source [SID1234641445]).
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"The fourth quarter of 2023 and early 2024 was a significant period for Enveric, highlighted by the selection of EB-003 as our lead development candidate. 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 Joseph Tucker, Ph.D., Director and CEO of Enveric. "Based on numerous discussions with large pharmaceutical companies, mental health professionals, and leading researchers, we believe it is evident 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."
Dr. Tucker continued, "The decision to designate EB-003 as our lead candidate was the culmination of an extensive design and evaluation process. This effort included the creation of more than one thousand compounds around which we have built a substantial intellectual property estate, increasing the attractiveness of these molecules for further development. Already in 2024, we have seen returns on this strategy in the form of out-licensing agreements as partners recognize the value of our innovative compounds that are protected with strong intellectual property and have the potential to exapand therapeutic options for patients with depression and anxiety. We will attempt to pursue additional out-licensing and partnership opportunities throughout the year as we continue to advance discussions with multiple possible partner companies."
Dr. Tucker concluded, "During the fourth quarter, we also continued to progress IND-enabling preclinical work for EB-002, completing important repeat-dose toxicology studies, genotoxicity studies, as well as cardiac, respiratory markers, and CNS safety pharmacology studies. We expect to finalize all preclinical activities for EB-002 soon, making the asset Phase 1 ready in 2024."
FOURTH QUARTER AND YEAR END UPDATES
Pipeline Advances and Highlight
Selected EB-003 as lead drug candidate from the Company’s next-generation EVM301 Series based on the molecule’s pharmacological properties and it’s potential to be a first-in-class treatment that addresses difficult-to-treat mental health disorders.
Presented two posters at the 6th Neuropsychiatric Drug Development Summit and two posters at the Canadian Chemical Engineering Conference (CSChE 2023) providing an update on the Company’s near-term selection EB-003 and highlighting key preclinical examinations of EB-002, a novel prodrug of psilocin.
Published cover article in the Journal of Medicinal Chemistry, a peer-reviewed journal published by the American Chemical Society, describing the development EB-002.
Progressed preclinical development of psilocin prodrug, EB-002, with GLP-toxicology and safety pharmacology studies, repeat dose toxicology studies, as well as cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies.
Expanded Business Development and Out-Licensing Opportunities in 2023 and 2024
Signed three non-binding term sheets with an undisclosed biotechnology company to pursue the out-licensing of three classes of compounds; future development and sales milestone payments and execution fees for the three licenses could total up to $200 million.
Signed two non-binding term sheets with a second undisclosed biotechnology company to pursue the out-licensing of cannabinoid conjugate compounds for pharmaceutical and non-pharmaceutical applications for the treatement of joint diseases; future development and sales milestone payments and execution fees for the two licenses could total up to $61 million.
Surpassed one thousand synthesized compounds discovered and characterized in our PsybraryTM portfolio of novel psychedelic-inspired molecules, following the acceleration of our AI-backed platform tailored for specific applications in the management of mental health disorders.
Continued to strengthen our intellectual property portfolio, receiving ten patent issuances from the United States Patent and Trademark Office.
FOURTH QUARTER AND FISCAL YEAR ENDED 2023 FINANCIAL RESULTS
Net loss attributable to stockholders was $3.44 million for the fourth quarter ended December 31, 2023, including $1.48 million in net non-cash expense, with a basic and diluted loss per share of $1.46, as compared to a net loss of $8.80 million, including $4.48 million in net non-cash expense, with a basic and diluted loss per share of $4.89 for the quarter ended December 31, 2022.
On December 28, 2023, the Company completed a warrant inducement transaction with two investors in which existing warrants were repriced and exercised and new warrants were issued to the investors. The cash proceeds from that transaction were received on January 4, 2024. Subsequently, on February 29, 2024, approximately 90% of the new warrants were also exercised. The gross proceeds to the Company from the two warrant exercises totaled approximately $4.5 million.