On April 3, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and provided financial results for the fourth quarter and year ended December 31, 2022 (Press release, Enveric Biosciences, APR 3, 2023, View Source [SID1234629744]).
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"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."
Dr. Tucker concluded: "2023 will be a year of substantial progress for Enveric, with acceleration of the pipeline milestones to enable us to rapidly grow into a leading, innovative CNS company. Mental health treatments have seen little innovation for decades; stigmatization has abetted a global epidemic in depression and anxiety, which continued to worsen as a result of the COVID-19 pandemic. At Enveric, we believe it’s time for bold innovation and investment to conquer the monumental challenge of tackling mental health disorders."
FOURTH QUARTER AND RECENT PROGRAM UPDATES
A Pipeline Targeting Unmet Needs in Mental Health
● EB-373 nominated as lead development candidate from EVM201 Series targeting the treatment of anxiety disorders
● Phase 1 clinical trial for EB-373 planned to initiate in the fourth quarter of 2023. The trial will be conducted in Australia via Enveric’s newly established subsidiary, Enveric Therapeutics.
○ Avance Clinical identified as CRO to conduct Phase 1 trial
● Enveric continues to advance its EVM301 Series targeting mood, anxiety and addiction disorders with unmet needs.
○ Enveric expects to identify optimal molecular candidates to advance into in vitro and in vivo testing by the third quarter of 2023
Dr. Tucker explained: "With EVM201 Series, we are seeking to address a major gap in innovation with rationally designed, next generation molecules that are prodrugs of the active psychedelic metabolite, psilocin. Through our advanced discovery platform, we’ve been able to design products with altered metabolic and pharmacokinetic properties with the goal of achieving improved risk/benefit profiles. Meanwhile, our EVM301 Series aims at minimizing or eliminating the hallucinatory effect, to enable administration without the compulsory presence of a healthcare professional to observe dosing. We believe this could offer a significant commercial opportunity, as current treatment standards with psychedelics necessitate costly, prolonged sessions with health care providers in attendance."
Positioned Financially and Operationally to be a Leading Developer of Novel Small-Molecule Therapeutics for the Treatment of Anxiety, Depression and Addiction Disorders
● Raised approximately $10 million in gross proceeds via public offering in February 2022
● An additional $8 million gross aggregate proceeds raised with registered direct and private placement offerings, which closed July 2022
● Anticipated spin-off of Akos Biosciences, Inc. (formerly Acanna Therapeutics, Inc.) announced
● Kevin Coveney named as Chief Financial Officer and Lynn Gallant as Vice President, Clinical Operations
Dr. Tucker commented: "The aggressive pace of pipeline developments that we expect in 2023 has been made possible by the execution of several key structural and business development transactions in 2022. This includes our February 2022 public offering, the planned spin-off of our cannabinoid clinical development pipeline assets, which we announced in May, and our registered direct and private placement offerings, which closed July 26, 2022."
FOURTH QUARTER AND YEAR END 2022 FINANCIAL RESULTS
Comprehensive net loss was $19.3 million for the year ended December 31, 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 the year ended December 31, 2021.
Net cash used in operations for the year ended December 31, 2022, was $17.1 million consisting of a $18.5M 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.
As of December 31, 2022, the Company had cash and cash equivalents of $17.7 million and working capital of $14.4 million.