Enveric Biosciences, Inc.

Enveric Biosciences, Inc. is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. The company operates in the biotechnology and pharmaceutical industries, which are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products. The psychedelic-inspired medicine industry is a new and emerging industry with ambiguous existing regulations and uncertainty as to future regulations. The company's lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT 2A and 5-HT 1B receptors with the potential to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.

The company faces potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions. Competitors include large and well-established companies that have greater commercial expertise, as well as small or early-stage companies that may prove to be competitors, particularly through collaborative arrangements with large and established companies. The company believes its scientific knowledge, technology, and development experience provide it with competitive advantages, and its success depends on its ability to protect its intellectual property and achieve and maintain key partnerships aimed at the development, licensing and marketing of psychedelic-inspired medicines without infringing on the proprietary rights of others.

The company is a pre-revenue biotech company that has to date not generated any revenues. Research and development activities are central to its business model, and it utilizes a combination of internal and external efforts to advance product development from early-stage work to future clinical trial manufacturing and clinical trial support. The company intends to focus on the development of novel and viable psychedelic-inspired drug candidates for mental illnesses and unmet medical needs, and partner with pharmaceutical and other drug development and biotechnology companies in developing and commercializing psychedelic-inspired medicines for diverse psychological and neuropsychiatric indications, which will be fundamentally composed of the psychedelic-inspired drug candidates contained in the Psybrary.

The company's lead program is the EVM301 Series, and its lead drug candidate, EB-003, is intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient. EB-003 is a novel derivative of N,N-Dimethyltryptamine (DMT) and is currently advancing through preclinical studies with the aim of initiating first-in-human studies to assess safety and tolerability including non-hallucinogenic properties, followed by clinical trials targeting the treatment of depression or other neuropsychiatric disorders. The EB-003 program has completed short-term dose-range finding toxicology studies and is now ready to advance into IND-enabling, GLP compliant safety pharmacology, ADMET and longer-term toxicology studies.

The company unveiled an EVM401 Series on February 25, 2025, which is intended to broaden its pipeline with additional non-hallucinogenic molecules and strengthen its ability to target addiction and neuropsychiatric disorders for patients with limited options. While the company intends to pursue development of the EVM401 Series, its primary focus is to develop its lead asset EB-003 in the EVM301 Series. The company owns rights to 19 active patent families related to compounds that are phenylalkylamine and indolethylamine derivatives, represented by a total of 24 issued United States patents and 59 pending United States and non-United States patent applications for treatment of mental disorders. The Psybrary currently includes 20 patent families with claims covering a million potential molecular structures, over one thousand of which have been synthesized in sufficient quantities to identify and hundreds of which have been screened for receptor binding and other relevant activities. The company licensed out its EVM201 portfolio to MycoMedica Life Sciences, PBC on November 7, 2024.

On January 30, 2025, the company commenced a best efforts public offering of an aggregate of 102,444 shares of common stock, 36,444 pre-funded warrants, 138,889 Series A warrants, and 138,889 Series B warrants, with net proceeds of approximately $4.2 million ¹. On April 9, 2025, the company entered into an At the Market Offering Agreement, and as of December 31, 2025, had issued 110,242 shares under the ATM Agreement for net cash proceeds of $1,636,799 ². On September 17, 2025, the company entered into warrant exercise inducement offer letters with certain holders of Series A Warrants and Series B Warrants, receiving aggregate gross proceeds of $2,218,873 ³ from the exercise of Existing Warrants. On December 11, 2025, the company entered into warrant exercise inducement offer letters with certain institutional investors, receiving aggregate gross proceeds of approximately $3.1 million ⁴ from the exercise of December Existing Warrants. The company effected a 1-for-12 reverse stock split on October 23, 2025.

For the year ended December 31, 2025, the company reported a net loss of $8,771,987 ⁵, compared to a net loss of $9,574,987 ⁶ for the year ended December 31, 2024. Total operating expenses were $8,774,448 ⁷ for 2025, compared to $9,632,266 ⁸ for 2024. The company had an accumulated deficit of $114,846,492 ⁹ as of December 31, 2025, and cash of $4,677,491 ¹⁰ with working capital of $4,018,307 ¹¹. Net cash used in operating activities was $8,141,543 ¹² for the year ended December 31, 2025. The company raised approximately $10.5 million ¹³ from the sales of its common stock and warrants during the year ended December 31, 2025.

The company's management has not provided specific quantitative revenue, margin, or EPS guidance for the upcoming period in the filing.

The primary growth vector is the advancement of the lead drug candidate EB-003 through preclinical studies with the aim of initiating first-in-human studies to assess safety and tolerability including non-hallucinogenic properties, followed by clinical trials targeting the treatment of depression or other neuropsychiatric disorders. The company intends to assemble a team of clinical experts and principal investigators with experience across multiple mental health and central nervous system indications to be responsible for the management, monitoring, and integrity of the clinical research. The company plans to submit filings including IND applications and, eventually, NDAs to seek approval with the FDA and with responsible regulatory agencies in other jurisdictions in connection with its product candidates.

A second growth vector is the EVM401 Series, unveiled on February 25, 2025, which is intended to broaden the company's pipeline with additional non-hallucinogenic molecules and strengthen its ability to target addiction and neuropsychiatric disorders for patients with limited options. While the company intends to pursue development of the EVM401 Series, its primary focus is to develop its lead asset EB-003 in the EVM301 Series. The company also intends to both continue to internally develop new drug candidates with associated intellectual property and to acquire, through in-licensing, additional intellectual property from pharmaceutical and biotechnology companies and research institutions.

The company's stock-based compensation costs were approximately $0.8 million ¹⁴ and $1.6 million ¹⁵ for the years ended December 31, 2025 and 2024, respectively. General and administrative expenses decreased to $5,792,573 ¹⁶ for the year ended December 31, 2025 from $6,453,505 ¹⁷ for the year ended December 31, 2024, a decrease of $660,932 ¹⁸, or 10% ¹⁹. Research and development expense for the year ended December 31, 2025 was $2,781,017 ²⁰ as compared to $2,841,272 ²¹ for the year ended December 31, 2024 with a decrease of $60,255 ²², or approximately 2% ²³.

The company has consolidated its employee base to save capital and focus on development of its lead candidate EB-003. As of the date of the Annual Report, the company employs five full-time employees and one part-time employee. The company also works with scientific advisors, consultants and service providers, mainly through academic institutions and contract research organizations. The company's principal corporate office is located at 245 First Street, Riverview II, 18th Floor, Cambridge, MA 02142 and is held under a month-to-month operating lease.

The company's operations have been funded principally through the issuance of debt and equity. During the year ended December 31, 2025, the company raised approximately $10.5 million ²⁴ from the sales of its common stock and warrants to purchase its common stock. Net cash provided by financing activities was $10,579,507 ²⁵ during the year ended December 31, 2025, which consisted of $4,698,241 ²⁶ in net proceeds from the exercise and inducement of warrants, $4,244,467 ²⁷ in net proceeds from the exercise of Common Stock and warrants, net of offering costs, and $1,636,799 ²⁸ in net proceeds from Common Stock sold for cash pursuant to the ATM Agreement, net of offering costs. On January 27, 2026, the company engaged in a registered direct offering and concurrent private placement, which locked-up its ability to engage in variable-rate transactions for a period of one year following January 27, 2026, subject to limited exceptions.

The company's independent registered public accounting firm issued a report dated March 27, 2026 in connection with the audit of the consolidated financial statements as of December 31, 2025, which included an explanatory paragraph describing the existence of conditions that raise substantial doubt about the company's ability to continue as a going concern including its recurring losses, cash used in operations, and need to raise additional funds to meet its obligations and sustain its operations. The company's current cash on hand is insufficient to satisfy its operating cash needs for the 12 months following the filing of the Annual Report. These conditions raise substantial doubt regarding the company's ability to continue as a going concern for a period of one year after the date the financial statements are issued.

The company's ability to continue as a going concern is dependent upon its ability to obtain substantial additional funding in connection with its continuing operations. Adequate additional financing may not be available to the company in the necessary timeframe, in the amounts it requires, on terms that are acceptable to it, or at all. If the company is unable to raise additional capital, its business, prospectus, financial condition and results of operations will be materially and adversely affected and it may be unable to continue as a going concern. The company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.

The company's independent registered public accounting firm has expressed substantial doubt about its ability to continue as a going concern as of December 31, 2025, due to recurring losses, cash used in operations, and the need to raise additional funds. As of December 31, 2025, the company had an accumulated deficit of $114,846,492 ²⁹ and operating cash outflows of $8,141,543 ³⁰ for the year then ended. The company is dependent on the success of its prospective product candidates, which are in early stages of development, and there can be no assurances that any such prospects will reach a particular stage in development, receive regulatory approval or be successfully commercialized. The company has never been profitable, has no products approved for commercial sale, and to date has not generated any revenue. The psychedelic-inspired drug candidates the company is developing may be subject to controlled substance laws and regulations in the United States and other countries, and failure to comply with these laws and regulations may adversely affect the results of its business operations and its financial condition. The company's common stock could be delisted from The Nasdaq Capital Market if it fails to comply with continued listing standards.

Management's message emphasizes the company's focus on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. Key themes include the advancement of the lead candidate EB-003, which is the first known compound designed to selectively engage both 5-HT 2A and 5-HT 1B receptors, and the unveiling of the EVM401 Series to broaden the pipeline. Strategic priorities emphasized for the period ahead include advancing EB-003 through preclinical studies with the aim of initiating first-in-human studies, submitting filings including IND applications and eventually NDAs to seek approval with the FDA, and continuing to internally develop new drug candidates while also acquiring additional intellectual property through in-licensing. Management also highlights the intention to use net proceeds from offerings for product development, working capital, and general corporate purposes.