Enveric Biosciences, Inc. annual report, FY2020

Enveric Biosciences, Inc. — FY 2020 Form 10-K

Reporting period: Fiscal year ended December 31, 2020. The filing is an annual report, not a standalone fourth-quarter report. The company was formerly AMERI Holdings, Inc.; on December 30, 2020, it completed the acquisition of Jay Pharma, changed its name to Enveric Biosciences, and spun off AMERI’s former operating businesses. The transaction was accounted for as a reverse acquisition, with Jay Pharma treated as the accounting acquirer. Accordingly, historical financial statements principally reflect Jay Pharma.

Business and financial overview

Enveric is an early-development-stage biosciences company pursuing cannabinoid-based prescription therapies for cancer supportive care and hard-to-treat cancers. Its disclosed pipeline was at research and discovery stage, including a topical candidate for oncology-related skin conditions and a proposed CBD-based combination program for recurrent or progressive glioblastoma. The company reported no product revenue in the results presented.

MetricFY 2020 / Dec. 31, 2020FY 2019 / Dec. 31, 2019
RevenueNone reportedNone reported
General and administrative expense$5.44 million$2.30 million
Research and development expense$174,083None reported
Operating loss$5.62 million$2.30 million
Net loss$6.86 million$2.41 million
Net loss per share, basic and diluted$1.19$0.46
Net cash used in operating activities$3.89 million$647,860
Cash and cash equivalents$1.58 million$43,714
Working capital$1.60 millionNot stated in the filing excerpt
Total liabilities$681,250$1.92 million
Notes and convertible notes payableNone$740,336 net of discounts

Margins are not meaningful given the absence of reported revenue. Total assets were $4.10 million at year-end, including $1.82 million of net intangible assets; shareholders’ equity was $3.42 million. The company recorded $1.98 million of stock-based compensation and $802,109 of warrant-inducement expense. Operating expenses increased 145% year over year, mainly from higher stock compensation, legal and professional fees, and R&D spending.

Changes, liquidity, and financing

  • Net loss increased from $2.41 million to $6.86 million; operating cash use rose from $648,000 to $3.89 million. Interest expense increased to $445,250 from $81,823, reflecting 2020 borrowing activity, while the company ended 2020 with no notes payable after debt conversions, repayments, and transaction-related exchanges.
  • FY 2020 financing activities provided $5.53 million, versus $560,000 in 2019. Year-end cash was $1.58 million; the filing reported $1.60 million working capital and an accumulated deficit of $11.76 million.
  • After year-end, Enveric completed registered direct offerings in January and February 2021 for gross proceeds of approximately $10.0 million and $12.8 million, respectively. It reported approximately $22.9 million cash on hand as of March 30, 2021, and management said this funding was sufficient for at least one year from issuance of the financial statements. Management also expects additional financing will be needed to execute its development plans over several years.
  • Financing involved substantial potential dilution, including new common shares and warrants. Alpha received, among other securities, five-year warrants for 1,791,923 shares at $0.01 per share, subject to beneficial-ownership limits. Verify all outstanding and exercisable securities when assessing the fully diluted share count.

Outlook, risks, and unusual items

  • No specific revenue, earnings, or clinical-development guidance was provided. Management’s stated strategy is to advance supportive-care and combination-therapy candidates through research, regulatory review, and prospective clinical studies. The proposed GBM protocol remained under hospital IRB review; the company was awaiting primary approval from Israel’s Ministry of Health. Product candidates had not received FDA approval.
  • The February 2021 PureForm agreement made PureForm the exclusive synthetic-CBD supplier for specified development programs, subject to agreement terms and an initial minimum order. A March 2021 Diverse Biotech license added five therapeutic candidates and required a $675,000 upfront payment plus royalties.
  • Key risks include early-stage drug-development and clinical-trial failure, FDA and foreign regulatory uncertainty, cannabinoid-related legal and public-perception risks, COVID-19 disruption, competition, dependence on future financing, and possible dilution. Trials planned outside the United States may not provide data acceptable to the FDA.
  • Management concluded that internal control over financial reporting and disclosure controls were ineffective at December 31, 2020 because of a material weakness in segregation of duties; remediation was in progress. The auditor issued an unqualified opinion on the financial statements but was not engaged to audit internal controls.
  • A stockholder demand challenged the approval process for the December 2020 1-for-4 reverse split. The company disputed the claim but planned to seek ratification at a special meeting scheduled for May 14, 2021. The filing also disclosed a post-year-end auditor change and the delisting of the legacy AMRHW warrants; the common stock continued trading as ENVB.
  • Other notable accounting items include $1.90 million of shares issued for skincare assets and $169,655 of foreign-exchange loss. The auditor identified valuation of the private-company shares issued for intangible assets as a critical audit matter.

Investor verification priorities

  • Confirm the current cash balance, expected cash burn, and realistic funding runway, distinguishing year-end cash from proceeds raised after year-end.
  • Reconcile the fully diluted share count, including Series B preferred stock, warrants, options, offering securities, and beneficial-ownership blockers.
  • Check the status and design of planned studies, required regulatory and ethics approvals, supply arrangements, and any evidence of clinical progress since the filing.
  • Review remediation of the segregation-of-duties material weakness and subsequent auditor or control-related disclosures.
  • Verify the outcome of the reverse-split ratification process and any resulting legal, listing, or capital-structure consequences.