CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, is pleased to announce that it has signed two non-binding term sheets with an undisclosed biotechnology company to pursue the out-licensing of cannabinoid-COX-2 conjugate compounds for both pharmaceutical and non-pharmaceutical applicatio ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, today announced that, on March 5, 2024, the United States Patent and Trademark Office issued U.S. Patent No. 11,918,594, titled “Multi-Substituent Psilocybin Derivatives” and is further expected to issue, on March 19, 2024, U.S. Patent No ...

Biotech investors know that small companies can make massive moves on big headlines, and we’re seeing such a move in Enveric Biosciences (NASDAQ:ENVB) today. Shares of ENVB stock are up more than 120% in early afternoon trading today after the company put forward a press release highlighting plans to license three classes of its compounds.This little-known biotech stock is one that’s garnering attention around this deal as Enveric looks to out-license three classes of its compounds. The company currently ha ...

In a release issued under the same headline on August 24, 2023 by Diamond Equity Research LLC, please note that the Disclosures paragraph has been replaced and includes the correct amount paid upfront for sponsored research, disregard all previous press release Disclosures on this ticker. The corrected release follows: NEW YORK, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has released Update Note on Enveric ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, today announced the company has agreed to sell one of its cancer-related patent portfolios for an undisclosed amount. Enveric plans to continue to focus and invest in the development of its lead candidates EB-003, a first-in-class neuropl ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, today announced the discovery of multiple, promising novel compounds sourced using the company’s Psybrary™ platform and proprietary computational chemistry and artificial intelligence (AI) drug-discovery system (PsyAI™). The novel compoun ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended: September 30, 2023 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ___ to ___ Commission File Number 001-38286 ENVERIC BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) FORM 10-Q (Registrant's telephone number, includi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended: June 30, 2023 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ___ to ___ Commission File Number 001-38286 ENVERIC BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 95-4484725 | | --- | --- | | (S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended: March 31, 2023 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ___ to ___ Commission File Number 001-38286 ENVERIC BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporati ...

Part I [Business](index=6&type=section&id=Item%201.%20Business) Enveric Biosciences develops novel small-molecule therapeutics for mental health and palliative care, focusing on psychedelic pipeline assets - The company is a biotechnology firm developing novel small-molecule therapeutics for anxiety, depression, and addiction disorders, as well as palliative care products for cancer patients[24](index=24&type=chunk) - Following the amalgamation with MagicMed in September 2021, the company is developing the **Psybrary™**, a proprietary library of psychedelic derivatives, and uses a proprietary **PsyAI™** tool to screen molecules and accelerate development[32](index=32&type=chunk)[33](index=33&type=chunk) - In May 2022, the company announced plans to spin off its cannabinoid clinical development pipeline assets to its majority-owned subsidiary, Akos Biosciences, Inc., to focus solely on psychedelic-based treatments[34](index=34&type=chunk)[36](index=36&type=chunk) Product Candidate Pipeline | Product Candidates | Targeted Indications | Status | Expected Next Steps | | :--- | :--- | :--- | :--- | | **EVM-201 (lead candidate EB-373)** | Anxiety | Research & Development, Lead Optimization | In-vitro and in-vivo experimentation; Phase 1 trial expected Q4 2023 | | **EVM-301** | Mental health indication | Research & Development, Hit-to-Lead Generation | In-vitro experimentation | | **EV104: CBD + Celecoxib Conjugate** | Osteoarthritis | Research & Development, Lead Optimization | Synthesis of molecular conjugates | | **Cannabinoid-Infused Topical Product** | Oncology-related skincare conditions (e.g., radiodermatitis) | Research & Development/Discovery | IND submission; Exploratory Phase 1/2 trial | - The company owns full rights to **16 patent applications** related to psychedelics, including psilocybin derivatives, prodrugs of psilocin, and mescaline derivatives[40](index=40&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.Risk%20Factors) The company faces substantial risks including going concern doubts, dependence on early-stage product success, and regulatory hurdles - 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, 2022, due to recurring losses and the need for additional funds[135](index=135&type=chunk) - The company is dependent on the success of its product candidates, which are in early stages of development and may never receive regulatory approval or be successfully commercialized[137](index=137&type=chunk) - Psychedelic product candidates are subject to strict controlled substance laws (**Schedule I**), complicating research and adding significant hurdles to potential commercialization[220](index=220&type=chunk)[224](index=224&type=chunk) - A **material weakness** in internal control over financial reporting was identified as of December 31, 2022, related to insufficient segregation of duties and lack of formalized control documentation[273](index=273&type=chunk)[274](index=274&type=chunk)[421](index=421&type=chunk) - The planned spin-off of the cannabinoid business into Akos Biosciences may not be completed successfully, potentially triggering a Put Right on Akos preferred stock by May 5, 2023, guaranteed by Enveric[310](index=310&type=chunk)[311](index=311&type=chunk)[312](index=312&type=chunk) - The company has a history of unprofitability, with an accumulated deficit of **$79.2 million**, and does not expect to be profitable in the foreseeable future[186](index=186&type=chunk) [Unresolved Staff Comments](index=59&type=section&id=Item%201B.Unresolved%20Staff%20Comments) The company reports no unresolved comments from the SEC staff [Properties](index=59&type=section&id=Item%202.%20Properties) The company's principal corporate office is in Naples, Florida, with a Canadian office and lab lease expiring in July 2023 - Principal corporate office is located in Naples, FL, under a month-to-month operating lease[316](index=316&type=chunk) - Canadian office is located in Calgary, Alberta, under an operating lease expiring in **July 2023**[316](index=316&type=chunk) [Legal Proceedings](index=59&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its financial position - The Company reports no pending litigation that would have a material adverse effect on its financial position, results of operations or cash flows[317](index=317&type=chunk) [Mine Safety Disclosures](index=59&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=60&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "ENVB"; it has never paid cash dividends and made no issuer equity purchases - Common stock is traded on the Nasdaq Capital Markets under the symbol **"ENVB"**[320](index=320&type=chunk) - The Company has never declared or paid cash dividends on its common stock and has no intention to do so in the foreseeable future[322](index=322&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=60&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of **$18.5 million** in 2022, a significant reduction from **$49.0 million** in 2021, with auditors expressing going concern doubts Results of Operations (Years Ended December 31) | | 2022 | 2021 | | :--- | :--- | :--- | | **Total operating expenses** | $27,415,106 | $64,623,420 | | General and administrative | $11,605,761 | $20,499,052 | | Research and development | $8,027,773 | $4,788,807 | | Impairment of intangible assets and goodwill | $7,453,662 | $38,678,918 | | **Loss from operations** | ($27,415,106) | ($64,623,420) | | **Net loss** | ($18,471,333) | ($48,976,896) | | **Net loss per share - basic and diluted** | ($13.00) | ($103.69) | - The company has incurred losses since inception, with an accumulated deficit of **$79.2 million** as of December 31, 2022, raising substantial doubt about its ability to continue as a going concern[383](index=383&type=chunk) - Management believes its current cash of **$17.7 million** (as of Dec 31, 2022) is sufficient to fund operations through **December 31, 2023**, but not for a full year, requiring additional capital[384](index=384&type=chunk)[581](index=581&type=chunk) - General and administrative expenses decreased by **43%** in 2022, primarily due to a **$10.2 million** reduction in stock-based compensation[374](index=374&type=chunk) - Research and development expenses increased by **68%** in 2022 to **$8.0 million**, driven by a full year of psychedelic product development activities[375](index=375&type=chunk) - The company recorded an impairment of intangible assets and goodwill of approximately **$7.5 million** in 2022 and **$38.7 million** in 2021, primarily due to a sustained decline in its stock price[362](index=362&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=74&type=section&id=Item%207A.Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) Not applicable [Financial Statements and Supplementary Data](index=74&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2022 and 2021, including balance sheets, statements of operations, and cash flows - The auditor's report from Marcum LLP for 2022 includes an explanatory paragraph expressing substantial doubt about the Company's ability to continue as a **going concern**[542](index=542&type=chunk) - Critical Audit Matters for the 2022 audit included impairment of long-lived assets and accounting for redeemable non-controlling interest and derivative liability related to the Akos spin-off[548](index=548&type=chunk) Consolidated Balance Sheet Highlights (As of December 31) | | 2022 | 2021 | | :--- | :--- | :--- | | **Total Assets** | **$19,552,925** | **$26,719,133** | | Cash | $17,723,884 | $17,355,999 | | Intangible assets, net | $379,686 | $6,923,928 | | Goodwill | $0 | $1,587,634 | | **Total Liabilities** | **$3,995,973** | **$4,413,213** | | **Total Shareholders' Equity** | **$14,671,924** | **$22,305,920** | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=74&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) None reported [Controls and Procedures](index=74&type=section&id=Item%209A.Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of December 31, 2022, due to material weaknesses in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **not effective** as of December 31, 2022[413](index=413&type=chunk) - **Material weaknesses** were identified in internal controls, including insufficient segregation of duties and lack of formalized control policies and procedures[417](index=417&type=chunk)[421](index=421&type=chunk) - Remediation efforts include engaging third-party experts to design internal controls, implementing new software, and using experts for independent supervision of accounting and financial reporting[422](index=422&type=chunk) [Other Information](index=75&type=section&id=Item%209B.Other%20Information) None reported [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=75&type=section&id=Item%209C.Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) Not applicable Part III [Directors, Executive Officers and Corporate Governance](index=76&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details the company's executive officers and seven-member Board of Directors, including key executives, board independence, and committee structures Executive Officers and Directors | Name | Position(s) | | :--- | :--- | | Joseph Tucker, Ph.D. | Chief Executive Officer and Director | | Avani Kanubaddi | President and Chief Operating Officer | | Dr. Bob Dagher | Chief Medical Officer | | Peter Facchini, Ph.D. | Chief Innovation Officer | | Kevin Coveney | Chief Financial Officer | | Michael Webb | Chair of the Board of Directors | | George Kegler | Director and Chair of the Audit Committee | | Dr. Douglas Lind | Director and Chair of the Nominating and Corporate Governance Committee | | Dr. Marcus Schabacker | Director | | Frank Pasqualone | Director and Chair of the Compensation Committee | | Bevin O'Neil | Director | - The Board has determined that **six of its seven members** are independent directors as defined by Nasdaq Listing Rules[449](index=449&type=chunk) - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, with all committee members being independent directors[451](index=451&type=chunk)[452](index=452&type=chunk) [Executive Compensation](index=83&type=section&id=Item%2011.%20Executive%20Compensation) This section details executive compensation for 2021 and 2022, including salaries, bonuses, and stock awards, along with severance provisions and amendments to the Long-Term Incentive Plan Summary Compensation Table (2022) | Name and Principal Position | Salary | Bonus | Stock Awards | Total | | :--- | :--- | :--- | :--- | :--- | | Joseph Tucker, CEO | $361,667 | $464,270 | $0 | $825,937 | | Avani Kanubaddi, President & COO | $335,833 | $209,138 | $755,626 | $1,300,597 | | Dr. Peter Facchini, CIO | $221,750 | $110,625 | $0 | $332,375 | - Employment agreements for the CEO, COO, and CIO include severance provisions for **12 months of base salary** upon termination without cause[467](index=467&type=chunk)[473](index=473&type=chunk)[480](index=480&type=chunk) - The 2020 Long-Term Incentive Plan was amended to increase the share reserve and add an **"evergreen" provision**, tying available shares to **15% of outstanding common stock**[491](index=491&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=94&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 30, 2023, directors and executive officers as a group beneficially owned **78,060 shares**, representing **3.8%** of outstanding common stock - As of March 30, 2023, all directors and executive officers as a group beneficially owned **78,060 shares** of common stock, representing **3.8%** of the outstanding shares[516](index=516&type=chunk) - No individual director or named executive officer beneficially owned more than **5%** of the company's common stock[516](index=516&type=chunk) [Certain Relationships and Related Transactions and Director Independence](index=95&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%20and%20Director%20Independence) The company entered a consulting agreement with former Executive Chairman David Johnson, providing a monthly fee of **$23,833** and a **$286,000** termination fee - On **January 1, 2023**, the Company entered into a consulting agreement with David Johnson, the former Executive Chairman[518](index=518&type=chunk) - Mr. Johnson will earn **$23,833 per month** for consulting services, with the agreement terminating upon the earlier of its terms or the Akos spin-off[518](index=518&type=chunk) [Principal Accountant Fees and Services](index=95&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The company's principal accountant is Marcum LLP, with total fees of **$286,095** in 2022 and **$235,110** in 2021, all pre-approved by the Audit Committee Accountant Fees | Fee Type | 2022 | 2021 | | :--- | :--- | :--- | | Audit fees | $286,095 | $170,025 | | Tax fees | $0 | $10,000 | | Audit-related fees | $0 | $5,150 | | All other fees | $0 | $49,935 | | **Total** | **$286,095** | **$235,110** | - In **September 2022**, Marcum LLP acquired certain assets of Friedman LLP, becoming the Company's auditor[519](index=519&type=chunk) - The Audit Committee's policy is to pre-approve all audit and non-audit services provided by the independent registered public accounting firm[524](index=524&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=96&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists documents filed as part of the Form 10-K, including financial statements and a detailed index of exhibits, with no financial statement schedules filed [Form 10–K Summary](index=97&type=section&id=Item%2016.%20Form%2010%E2%80%93K%20Summary) Not applicable