−Removed: Management’s discussion and analysis of financial condition and results of operations
−Removed: to the “Company,” “our,” “us,” or “we” in this section titled “Management’s
−Removed: Discussion and Analysis of Financial Condition and Results of Operations of Enveric” refer to Enveric Biosciences, Inc.
−Removed: The following
−Removed: discussion and analysis of our financial condition and results of operations should be read together with our financial statements and
−Removed: related notes appearing elsewhere in this Annual Report on Form 10-K.
−Removed: Some of the information contained in this discussion and analysis
−Removed: or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business
−Removed: and related financing, includes forward-looking statements involving risks and uncertainties and should be read together with the “Risk
−Removed: Factors” and the “Cautionary Statement Regarding Forward-Looking Statements” sections of this Annual Report on Form
−Removed: Such risks and uncertainties could cause actual results to differ materially from the results described in or implied by the forward-looking
−Removed: statements contained in the following discussion and analysis.
−Removed: are a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression,
−Removed: anxiety, addiction, and other psychiatric disorders.
−Removed: Leveraging our unique discovery and development platform, the Psybrary™, which
−Removed: houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric
−Removed: seeks to develop a robust intellectual property portfolio of novel drug candidates.
−Removed: lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment
−Removed: of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations
−Removed: in the patient.
−Removed: Enveric unveiled its EVM401 Series on February 25, 2025, which is intended to broaden Enveric’s pipeline with additional
−Removed: non-hallucinogenic molecules and strengthen its ability to target addiction and neuropsychiatric disorders for patients with limited
−Removed: Previously, Enveric was developing the EVM201 Series, and its drug candidate EB-002 (formerly EB-373), for the treatment of
−Removed: neuropsychiatric disorders.
−Removed: The EVM201 Series comprised next generation synthetic prodrugs of the active metabolite, psilocin.
−Removed: Enveric out-licensed the EVM201 Series program to MycoMedica Life Sciences, who will seek to develop, manufacture, and commercialize
−Removed: EB-002, in exchange for certain development and milestone payments to Enveric (discussed below).
−Removed: Neuroplastogens
−Removed: our amalgamation with MagicMed in September 2021, we have continued to pursue the development of MagicMed’s proprietary library,
−Removed: the Psybrary™, which we believe will help us to identify and develop the right drug candidates needed to address mental health
−Removed: challenges, including depression, anxiety, and addiction disorders.
−Removed: We synthesize novel phenylalkylamines and indolethylamines, using
−Removed: a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which currently includes 20 patent families
−Removed: with claims covering a million potential molecular structures, over one thousand of which we have so far synthesized in sufficient quantities
−Removed: to identify and hundreds of which we have screened for receptor binding and other relevant activities.
−Removed: Company developed certain intellectual property rights around the trademark PsyAI™ for potential use.
−Removed: On March 6, 2025, Enveric
−Removed: announced it is soliciting Requests-For Proposals (“RFPs”) for the license or sale of its PsyAI™ trademark portfolio
−Removed: as a means of maximizing value for an asset which is no longer strategic given the Company’s focus on drug development.
−Removed: portfolio of US and Canadian trademark assets is held by its subsidiary, Enveric Biosciences Canada, Inc.
−Removed: Enveric expects the period
−Removed: for RFPs to remain open until August 31, 2025, with a decision to follow within three (3) months thereafter.
−Removed: this stage, we have entered into several non-binding term sheets with strategic partners to out-license certain molecules from the Psybrary™.
−Removed: Going forward, in order to build a pipeline of product candidates, we intend to both continue to internally develop new drug candidates
−Removed: with associated intellectual property and to acquire, through in-licensing, additional intellectual property from pharmaceutical and
−Removed: biotechnology companies and research institutions.
−Removed: The in-licensed assets could include both research stage and clinical stage drug candidates.
−Removed: we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series.
−Removed: development status of the product is shown in the table below:
−Removed: health indication
−Removed: Psychedelic-inspired
−Removed: drug candidate
−Removed: effected a 1-for-15 reverse stock split on January 27, 2025, which began trading on a split-adjusted basis on January 29, 2025, pursuant
−Removed: to which every 15 shares of our issued and outstanding common stock were reclassified as one share of common stock.
−Removed: No fractional shares
−Removed: were issued as a result of the reverse stock split.
−Removed: Any fractional shares that were to otherwise have resulted from the reverse stock
−Removed: split were rounded up to the next whole number.
−Removed: The reverse stock split had no impact on the par value of our common stock or the authorized
−Removed: number of shares of our common stock.
−Removed: Bid Price Deficiency
−Removed: May 16, 2024, the Company received a letter from Nasdaq notifying the Company that for the prior 30 consecutive business days the bid
−Removed: price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on Nasdaq pursuant
−Removed: to Nasdaq Listing Rule 5550(a)(2) (“Bid Price Rule”).
−Removed: The deficiency letter did not result in the immediate delisting of
−Removed: the Company’s common stock from Nasdaq.
−Removed: In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial
−Removed: period of 180 calendar days, until November 12, 2024, to regain compliance with the Bid Price Rule.
−Removed: On November 20, 2024, Nasdaq issued
−Removed: a delisting notice, indicating that the Company did not satisfy the Bid Price Rule by the compliance date and that unless the Company
−Removed: requested an appeal of this determination before Nasdaq’s listing qualifications panel, our common stock would be scheduled for
−Removed: delisting from Nasdaq and trading suspended.
−Removed: We appealed the determination before Nasdaq’s listing qualifications panel and on
−Removed: December 30, 2024, the Company received an extension until May 19, 2025, to regain compliance with Bid Price Rule.
−Removed: On March 4, 2025,
−Removed: the Company received notice from the Nasdaq Office of General Counsel that the Company regained
−Removed: compliance with the Bid Price Rule.
−Removed: Agreement with MycoMedica Life Sciences
−Removed: November 7, 2024, Enveric executed a licensing agreement with MycoMedica Life Sciences, PBC (“MycoMedica”), out-licensing
−Removed: the Company’s EVM201 program, including drug candidate EB-002.
−Removed: Pursuant to the terms of licensing agreement, MycoMedica will seek
−Removed: to develop, manufacture, and commercialize EB-002, formerly EB-373, a synthetic prodrug of the active metabolite psilocin, for the treatment
−Removed: of neuropsychiatric disorders such as depression.
−Removed: MycoMedica received an exclusive, global license to the formulations, drugs, method
−Removed: of use, and medical devices developed by Enveric to utilize the compound.
−Removed: MycoMedica assumed the responsibility for all future preclinical,
−Removed: clinical, and commercial development on a royalty-bearing basis for all human and animal pharmaceutical applications.
−Removed: As part of the
−Removed: license agreement, Enveric received a modest upfront payment of $20,000 (recorded as other income), and if certain conditions are met,
−Removed: will receive development and sales milestones potentially totaling up to $62 million, plus tiered single digit royalties on all future
−Removed: MycoMedica has the option during the license term to buyout its milestone and royalty payment obligations at a predetermined amount
−Removed: depending upon the stage of product development and commercialization at the time of the buyout.
−Removed: Further, MycoMedica has the right to
−Removed: purchase the licensed patents at a nominal amount upon a change of control of Enveric, although doing so does not relieve MycoMedica
−Removed: of any of its payment obligations.
−Removed: No royalties have been received to date.
−Removed: Agreement with Aries Science and Technology
−Removed: July 10, 2024, Akos Biosciences, Inc., a Delaware corporation (“Akos”), wholly-owned subsidiary of Enveric, entered into
−Removed: an exclusive license agreement with Aries Science and Technology, LLC (“Aries”) pursuant to which Akos granted Aries a license
−Removed: of Akos’s patented radiation dermatitis topical product.
−Removed: The license allows Aries to use the patented formulation to develop pharmaceutical
−Removed: or non-pharmaceutical products for treating radiation dermatitis suitable for administration to humans or animals.
−Removed: The license is exclusive
−Removed: (subject to certain exceptions contained in the Agreement), worldwide, royalty-bearing, and includes the right to sublicense.
−Removed: will be eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties on future sales, if all conditions
−Removed: Aries has the option during the license term, to purchase the rights to each licensed product (on a licensed product-by-licensed
−Removed: product basis) in the form of an exclusive (as to the applicable licensed product), fully paid, transferable right and license to the
−Removed: licensed product.
−Removed: No royalties have been received to date.
−Removed: Distribution Agreement
−Removed: September 1, 2023, the Company entered into a Distribution Agreement (“Distribution Agreement”), with Canaccord Genuity,
−Removed: LLC (“Canaccord”), pursuant to which the Company may offer and sell from time to time, through Canaccord as sales agent and/or
−Removed: principal, shares of common stock of the Company having an aggregate offering price of up to $10.0 million.
−Removed: Due to the offering limitations
−Removed: applicable to the Company and in accordance with the terms of the Distribution Agreement, the Company may offer common stock having an
−Removed: aggregate gross sales price of up to $2,392,514 pursuant to the prospectus supplement dated September 1, 2023.
−Removed: Subject to the terms and
−Removed: conditions of the Distribution Agreement, Canaccord may sell the common stock by any method permitted by law deemed to be an “at-the-market
−Removed: The Company will pay Canaccord a commission equal to 3.0% of the gross sales price of the common stock sold through
−Removed: Canaccord under the Distribution Agreement and has also agreed to reimburse Canaccord for certain expenses.
−Removed: The Company may also sell
−Removed: common stock to Canaccord as principal for Canaccord’s own account at a price agreed upon at the time of sale.
−Removed: Any sale of common
−Removed: stock to Canaccord as principal would be pursuant to the terms of a separate terms agreement between the Company and Canaccord.
−Removed: the year ended December 31, 2024, the Company issued 111,200 shares of common stock for gross proceeds of $2,392,502 under the Distribution
−Removed: Agreement, and charged offering costs of $583,713 to additional paid in capital on the consolidated balance sheet.
−Removed: As of December 31,
−Removed: 2024 and 2023, there were deferred offering costs related to the Distribution Agreement of $0 and $171,944, respectively.
−Removed: does not anticipate issuing further securities pursuant to the Distribution Agreement.
−Removed: Park Equity Line
−Removed: November 3, 2023, the Company entered into a Purchase Agreement (the “Lincoln Park Purchase Agreement”) and a registration
−Removed: rights agreement (the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”),
−Removed: pursuant to which Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock subject to certain limitations
−Removed: and satisfaction of the conditions set forth in the Lincoln Park Purchase Agreement.
−Removed: the terms and subject to the conditions of the Lincoln Park Purchase Agreement, the Company has the right, but not the obligation, to
−Removed: sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the “Purchase
−Removed: However, such sales of Common Stock by the Company, if any, will be subject to important limitations set forth in the
−Removed: Lincoln Park Purchase Agreement, including limitations on number of shares that may be sold.
−Removed: Sales may occur from time to time, at the
−Removed: Company’s sole discretion, over the 24-month period commencing on the date that the conditions to Lincoln Park’s purchase
−Removed: obligation set forth in the Lincoln Park Purchase Agreement are satisfied, including that a registration statement on Form S-1 covering
−Removed: the resale of the shares of the Company’s Common Stock that have been and may be issued to Lincoln Park under the Lincoln Park
−Removed: Purchase Agreement, which the Company has filed with the SEC pursuant to the Registration Rights Agreement, is declared effective by
−Removed: the SEC and a final prospectus relating thereto is filed with the SEC.
−Removed: As required under the Lincoln Park Purchase Agreement, the Company
−Removed: registered a resale of 76,032 shares of our common stock, plus the 9,294 commitment shares, by Lincoln Park on a registration statement
−Removed: on Form S-1 dated November 8, 2023, which was declared effective by the SEC on December 5, 2023.
−Removed: As of July 30, 2024, there were no remaining
−Removed: shares available to be issued in connection with this registration statement.
−Removed: On September 4, 2024, the Company filed a new registration
−Removed: statement on Form S-1, which was declared effective by the SEC on September 11, 2024.
−Removed: The new Form S-1 registered an additional 326,667
−Removed: shares of common stock that are available to be issued to Lincoln Park in connection with the Lincoln Park Purchase Agreement.
−Removed: the year ended December 31, 2024, the Company had issued 159,366 shares of common stock, through the Lincoln Park Purchase Agreement
−Removed: for gross cash proceeds of $1,083,709.
−Removed: As of December 31, 2024 there were 243,334 remaining shares available to be issued in connection
−Removed: with this amended registration statement.
−Removed: The Company engaged in a best efforts public offering in the first quarter of 2025 (described
−Removed: below), which restricts the use of the Lincoln Park Equity Line for a period of one year from February 3, 2025.
−Removed: the purchase price per share to be paid by Lincoln Park for the shares of Common Stock that the Company may elect to sell to Lincoln
−Removed: Park under the Lincoln Park Purchase Agreement, if any, will fluctuate based on the market prices of the Company’s Common Stock
−Removed: at the time the Company elects to sell shares to Lincoln Park pursuant to the Lincoln Park Purchase Agreement, if any, it is not possible
−Removed: for us to predict the number of shares of Common Stock that the Company will sell to Lincoln Park the purchase price per share that Lincoln
−Removed: Park will pay for shares purchased from us or the aggregate gross proceeds that the Company will receive from those purchases by Lincoln
−Removed: Direct Offerings
−Removed: March and May 2024, the Company entered into a series of common stock purchase agreements (the “Purchase Agreements”) for
−Removed: the issuance in a registered direct offering of an aggregate of 45,780 shares of the Company’s common stock to certain institutional
−Removed: The issuance was made in exchange for the permanent and irrevocable waiver of the variable rate transaction limitation contained
−Removed: in certain inducement offer letters, dated December 28, 2023, between the Company and the institutional investors with respect to any
−Removed: existing or future agreement by the Company to effect any issuance of shares.
−Removed: The Company did not receive any net proceeds in connection
−Removed: with the offering.
−Removed: The offering was made to obtain a waiver of the variable rate transaction limitation as described above and further
−Removed: described in the Purchase Agreements so the Company could utilize its equity line of credit with Lincoln Park, and enter into any future
−Removed: agreements that involve a variable rate transaction and issue such shares thereunder.
−Removed: The fair value of the shares issued for consideration
−Removed: of waiving the variable rate transaction limitation was $322,453 and was charged to additional paid in capital, as it is direct and incremental
−Removed: to the Distribution Agreement, on the unaudited condensed consolidated balance sheet as an offering cost related to the Distribution
−Removed: The fair value of the shares issued for consideration of waiving the variable rate transaction limitation was $448,840 and
−Removed: was recorded as deferred offering costs, as direct and incremental to the Purchase Agreement, within prepaid expenses and other current
−Removed: assets on the unaudited condensed consolidated balance sheet related to the Purchase Agreement.
−Removed: 2025 Offering
−Removed: January 30, 2025, the Company commenced a best efforts public offering (the “Offering”) of an aggregate of (i) 1,229,330
−Removed: shares (the “Shares”) of common stock of the Company, (ii) 437,336 pre-funded warrants (the “Pre-Funded Warrants”)
−Removed: to purchase 437,336 shares of common stock (the “Pre-Funded Warrant Shares”), (iii) 1,666,666 Series A warrants (the “Series
−Removed: A Warrants”) to purchase 1,666,666 shares of common stock (the “Series A Warrant Shares”), and (iv) 1,666,666 Series
−Removed: B warrants (the “Series B Warrants,” and together with the Series A Warrants, the “Warrants”) to purchase 1,666,666
−Removed: shares of common stock (the “Series B Warrant Shares”).
−Removed: Each Share or Pre-Funded Warrant was sold together with one Series
−Removed: A Warrant to purchase one share of common stock and one Series B Warrant to purchase one share of common stock.
−Removed: The offering price for
−Removed: each Share and accompanying Warrants was $3.00, and the offering price for each Pre-Funded Warrant and accompanying Warrants was $2.9999.
−Removed: The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full.
−Removed: Each Warrant has an exercise price of $3.00 per share and will be exercisable immediately upon issuance (“Initial Exercise Date”).
−Removed: The Series A Warrants expire on the five-year anniversary of the Initial Exercise Date.
−Removed: The Series B Warrants expire on the 18-month
−Removed: anniversary of the Initial Exercise Date.
−Removed: Offering closed on February 3, 2025.
−Removed: The net proceeds of the Offering, after deducting the fees and expenses of the Placement Agent (as
−Removed: defined below) and other offering expenses payable by the Company, but excluding the net proceeds, if any, from the exercise of the Warrants,
−Removed: is approximately $4.2 million.
−Removed: The Company intends to use the net proceeds from the Offering for working capital, EB-003 development,
−Removed: and general corporate purposes.
−Removed: are a pre-revenue biotech company that has to date, not generated any revenues.
−Removed: During the year ended December 31, 2024, we raised approximately
−Removed: $8.0 million from the sales of Common Stock and warrants.
−Removed: These amounts were the primary source of funds upon which our operations were
−Removed: financed during the year ended December 31, 2024.
−Removed: and Development Expenses
−Removed: and development expenses consist primarily of costs incurred for the research and development of our preclinical product candidates,
−Removed: and include, without limitation:
−Removed: employee-related
−Removed: expenses, including salaries, benefits and share-based compensation expense;
−Removed: incurred under agreements with contract research organizations, contract manufacturing organizations, and consultants and other entities
−Removed: engaged to support our product research and development activities;
−Removed: cost of acquiring, developing and manufacturing materials and lab supplies used in research and development activities;
−Removed: equipment, depreciation and other expenses, which include, without limitation direct and allocated expenses for rent, maintenance
−Removed: of our facilities and equipment, insurance and other supplies;
−Removed: associated with preclinical activities and regulatory operations, including, without limitation, patent related costs;
−Removed: and professional fees associated with research and development activities.
−Removed: expense research and development costs to operations as incurred.
+Added: Management’s discussion
+Added: and analysis of financial condition and results of operations
+Added: References to the “Company”,
+Added: “Enveric,” “our,” “us,” or “we” in this section titled “Management’s Discussion
+Added: and Analysis of Financial Condition and Results of Operations of Enveric” refer to Enveric Biosciences, Inc.
+Added: The following discussion
+Added: and analysis of our financial condition and results of operations should be read together with our financial statements and related notes
+Added: appearing elsewhere in this Annual Report.
+Added: Some of the information contained in this discussion and analysis or set forth elsewhere in
+Added: this Annual Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking
+Added: statements involving risks and uncertainties and should be read together with the “Risk Factors” and the “Cautionary
+Added: Statement Regarding Forward-Looking Statements” sections of this Annual Report.
+Added: Such risks and uncertainties could cause actual
+Added: results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion
+Added: and analysis.
+Added: Business Overview
+Added: We are a biotechnology company
+Added: focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological
+Added: By leveraging a differentiated drug discovery platform and a growing library of patent protected chemical structures, we are
+Added: advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects.
+Added: Our lead candidate, EB-003,
+Added: is the first known compound designed to selectively engage both 5-HT 2A and 5-HT 1B receptors with the potential to
+Added: deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.
+Added: Our lead program, the EVM301
+Added: Series, and our lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment of difficult-to-address
+Added: mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient.
+Added: is a novel derivative of DMT.
+Added: It is currently advancing through preclinical studies with the aim of initiating first-in-human studies
+Added: to assess safety and tolerability including non-hallucinogenic properties, followed by clinical trials targeting the treatment of depression
+Added: or other neuropsychiatric disorders.
+Added: We intend to assemble a team
+Added: of clinical experts and principal investigators with experience across multiple mental health and central nervous system indications to
+Added: be responsible for the management, monitoring, and integrity of the clinical research.
+Added: We plan to submit filings including IND applications
+Added: and, eventually, NDAs to seek approval with the FDA and with responsible regulatory agencies in other jurisdictions, in connection with
+Added: our product candidates.
+Added: The selection, timing, duration, and design of any prospective studies are subject to regulatory filings, approval
+Added: and finalization of commercial plans.
+Added: Our EB-003 program has completed short-term dose-range finding toxicology studies and is now ready
+Added: to advance into IND-enabling, GLP compliant safety pharmacology, ADMET and longer-term toxicology studies.
+Added: We unveiled the EVM401 Series
+Added: on February 25, 2025, which is intended to broaden its pipeline with additional non-hallucinogenic molecules and strengthen our ability
+Added: to target addiction and neuropsychiatric disorders for patients with limited options.
+Added: While we intend to pursue development of the EVM401
+Added: Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series.
+Added: Recent Developments
+Added: At the Market Offering
+Added: On April 9, 2025, we entered
+Added: into an At the Market Offering Agreement (“ATM Agreement”), with H.C.
+Added: Wainwright & Co., LLC, acting as sales agent.
+Added: of December 31, 2025, we had issued 110,242 shares under the ATM Agreement for net cash proceeds of $1,636,799.
+Added: On February 6, 2026, we
+Added: filed a prospectus supplement so that we may additionally issue and sell our common stock having an aggregate sales proceeds of up to
+Added: $1,346,000 from time to time pursuant to the ATM Agreement.
+Added: On February 19, 2026, the Company issued 497,200 shares of our common stock
+Added: for net cash proceeds of $1,303,415.
+Added: Registered Direct Offering and Concurrent
+Added: Private Placement
+Added: On January 27, 2026, we entered
+Added: into a securities purchase agreement with certain institutional investors, pursuant to which we agreed to issue and sell to the investors
+Added: in a registered direct offering (the “Registered Direct Offering”), an aggregate of 328,802 shares (the “RD Shares”)
+Added: of our common stock at a price of $4.41 per share for gross proceeds of approximately $1.5 million before the deduction of placement agent
+Added: fees and offering expenses.
+Added: The closing of the Registered Direct Offering occurred on January 28, 2026.
+Added: In the concurrent private
+Added: placement we also agreed to issue and sell to the Investors the Series G Warrants to purchase up to an aggregate of 328,802 shares of
+Added: common stock and the Series H Warrants purchase up to an aggregate of 328,802 shares of common stock, each at an exercise price of $4.16
+Added: We issued H.C.
+Added: & Co., LLC, as placement agent, warrants to purchase up to 23,016 shares of common stock with an exercise price of $5.5125 per share.
+Added: We also incurred legal and other offering-related fees in connection with this offering.
+Added: December 2025 Inducement Warrant Transaction
+Added: On December 11, 2025, we entered
+Added: into warrant exercise inducement offer letters (the “December Inducement Letters”) with certain institutional investors that
+Added: held certain outstanding warrants to purchase up to an aggregate of 426,390 shares originally issued in February 2025 and September 2025,
+Added: having exercise prices of $36.00 and $10.98 per share, respectively (collectively, the “December Existing Warrants”).
+Added: Pursuant to the December Inducement
+Added: Letters, the investors agreed to exercise for cash their December Existing Warrants at a reduced exercise price of $7.05 per share and
+Added: pay a purchase price of $0.125 per share in consideration for our agreement to issue in a private placement (x) new Series E Common Stock
+Added: Purchase Warrants to purchase up to 426,390 shares of common stock and (y) new Series F Common Stock Purchase Warrants to purchase up
+Added: to 426,390 shares of common stock.
+Added: We received aggregate gross proceeds of approximately $3.1 million from the exercise of the December
+Added: Existing Warrants by the investors and payment of the purchase price of $0.125 per share, before deducting placement agent fees and other
+Added: offering expenses payable by us.
+Added: The closing of the transactions occurred on December 12, 2025.
+Added: We issued H.C.
+Added: & Co., LLC, as placement agent, warrants to purchase up to 29,847 shares of common stock with an exercise price of $9.125 per share.
+Added: We also incurred legal and other offering-related fees in connection with this warrant inducement transaction.
+Added: Nasdaq Compliance on Minimum Bid Price Deficiency
+Added: By way of background, on October
+Added: 22, 2025, we received written notice from the Listing Qualifications Department of Nasdaq notifying the Company that, because the closing
+Added: price of our common stock had fallen below $1.00 per share for 30 consecutive trading days, we were no longer in compliance with the requirement
+Added: for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2).
+Added: On November 12, 2025, we received a letter from the Nasdaq Listing
+Added: Qualifications Department of Nasdaq notifying us that we regained compliance with the minimum bid price requirement set forth in in Nasdaq
+Added: Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market.
+Added: October 2025 Reverse Stock Split
+Added: On October 23, 2025, we effected
+Added: a 1-for-12 reverse stock split (the “October 2025 Reverse Stock Split”), which began trading on a split-adjusted basis on
+Added: October 28, 2025, pursuant to which every 12 shares of our issued and outstanding shares of common stock were reclassified as one share
+Added: of common stock.
+Added: The October 2025 Reverse Stock Split had no impact on the par value of our common stock or the authorized number of shares
+Added: of common stock.
+Added: Unless otherwise indicated, all share and per share information prior to the October 2025 Reverse Stock Split date of
+Added: October 28, 2025 in this Annual Report are retroactively adjusted to reflect the October 2025 Reverse Stock Split.
+Added: Nasdaq Compliance on Stockholders’ Equity
+Added: On October 23, 2025, we notified
+Added: Nasdaq that we believed we had regained compliance with the stockholders’ equity requirements set forth in Nasdaq Listing Rule 5550(b)(1)
+Added: for continued listing on The Nasdaq Capital Market.
+Added: On October 24, 2025, we received a letter from Nasdaq determining that we regained
+Added: conditional compliance subject to evidencing compliance upon filing our next periodic report.
+Added: As detailed in our Quarterly Report for
+Added: the quarter ended September 30, 2025, filed with the SEC on November 14, 2025, we reported stockholders’ equity in excess of the
+Added: required $2.5 million and, as a result, regained compliance with the stockholders’ equity requirement.
+Added: On August 26, 2025, we had
+Added: received a deficiency letter from the Listing Qualifications Department of Nasdaq notifying the Company that it was not in compliance
+Added: with the minimum stockholders’ equity requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(b)(1).
+Added: September 2025 Inducement Warrant Transaction
+Added: On September 17, 2025, we
+Added: entered into warrant exercise inducement offer letters (the “September Inducement Letters”) with certain holders of our Series
+Added: A Warrants and Series B Warrants originally issued in February 2025 (the “September Existing Warrants”), which closed on September
+Added: Pursuant to the September Inducement Letters, the holders agreed to exercise for cash their September Existing Warrants to purchase
+Added: 202,083 shares of our common sock, in the aggregate, at a reduced exercise price of $10.98 per share (from an original exercise price
+Added: of $36.00 per share), in exchange for our agreement to issue new warrants Series C Warrants and Series D Warrants to purchase up to 404,166
+Added: shares of the our common stock under each series, each at an exercise price of $10.98 per share.
+Added: We received aggregate gross
+Added: proceeds of $2,218,873 from the exercise of the Existing Warrants.
+Added: We issued H.C.
+Added: Wainwright & Co., LLC, as placement agent warrants
+Added: to purchase up to 14,146 shares of common stock with an exercise price of $13.7256 per share.
+Added: The grant date fair value of these placement
+Added: agent warrants was estimated to be $90,000 on September 18, 2025 and was charged to additional paid-in capital as issuance costs.
+Added: incurred legal and other offering-related fees of $334,659, which were similarly charged to additional paid-in capital.
+Added: January 2025 Public Offering
+Added: On January 30, 2025, we commenced
+Added: a best efforts public offering (the “Public Offering”) of an aggregate of (i) 102,444 shares of common stock, (ii) 36,444
+Added: pre-funded warrants to purchase 36,444 shares of common stock , (iii) 138,889 Series A warrants to purchase 138,889 shares of common stock,
+Added: and (iv) 138,889 Series B warrants to purchase 138,889 shares of common stock.
+Added: Each share of common stock or pre-funded warrant was sold
+Added: together with one Series A Warrant to purchase one share of common stock and one Series B Warrant to purchase one share of common stock.
+Added: The offering price for each share and accompanying Series A and Series B Warrants was $36.00, and the offering price for each re-funded
+Added: warrant and accompanying warrants was $35.9988.
+Added: The pre-funded warrants have an exercise price of $0.0012 per share, are exercisable immediately
+Added: and expire when exercised in full.
+Added: Each warrant has an exercise price of $36.00 per share and are exercisable immediately upon issuance.
+Added: The Series A Warrants expire five years after issuance.
+Added: The Series B Warrants expire 18-months after issuance.
+Added: The Public Offering closed
+Added: on February 3, 2025.
+Added: The net proceeds of the Public Offering, after deducting the fees and expenses of the H.C.
+Added: Wainwright & Co.,
+Added: LLC, as placement agent, and other offering expenses payable by us, but excluding the net proceeds, if any, from the exercise of the warrants,
+Added: was approximately $4.2 million.
+Added: Financial Overview
+Added: We are a pre-revenue biotech
+Added: company that has to date, not generated any revenues.
+Added: During the year ended December 31, 2025, we raised approximately $10.5 million from
+Added: the sales of our common stock and warrants to purchase our common stock.
+Added: These amounts were the primary source of funds upon which our
+Added: operations were financed during the year ended December 31, 2025.
+Added: Research and Development Expenses
+Added: Research and development expenses
+Added: consist primarily of costs incurred for the research and development of our preclinical product candidates, and include, without limitation:
+Added: ● employee-related expenses, including salaries, benefits and share-based compensation expense;
+Added: ● expenses incurred under agreements with contract research organizations, contract manufacturing organizations,
+Added: and consultants and other entities engaged to support our product research and development activities;
+Added: ● the cost of acquiring, developing and manufacturing materials and lab supplies used in research and development
+Added: ● facility, equipment, depreciation and other expenses, which include, without limitation direct and allocated
+Added: expenses for rent, maintenance of our facilities and equipment, insurance and other supplies;
+Added: ● costs associated with preclinical activities and regulatory operations, including, without limitation,
+Added: patent related costs;
+Added: ● consulting and professional fees associated with research and development activities.
+Added: We expense research and development
+Added: costs to operations as incurred.
Research and development activities are central to our business model.
−Removed: We utilize a combination of internal and external efforts to advance product development from early-stage work to future clinical trial
−Removed: manufacturing and clinical trial support.
−Removed: External efforts include work with consultants and increasingly substantial work at CROs and
−Removed: We support an internal research and development team in Calgary, Alberta, Canada.
−Removed: To move these programs forward along our development
−Removed: timelines, a large portion (approximately 75%) of our staff are research and development employees.
−Removed: In January 2024, the Company reduced
−Removed: its discovery team in Calgary and was primarily focused on the development of EB-002 and EB-003 pipeline assets (until we out-licensed
−Removed: EB-002 to MycoMedica Lifesciences in November of 2024).
−Removed: Because of the numerous risks and uncertainties associated with product development,
−Removed: however, we cannot determine with certainty the duration and completion costs of these or other current or future preclinical studies
−Removed: and clinical trials.
−Removed: The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety
−Removed: of factors, including the uncertainties of future clinical and preclinical studies, uncertainties in clinical trial enrollment rates
−Removed: and significant and changing government regulation.
−Removed: In addition, the probability of success for each product candidate will depend on
−Removed: numerous factors, including competition, manufacturing capability and commercial viability.
−Removed: and Administrative Expenses
−Removed: and administrative expenses consist principally of salaries, benefits and related costs such as stock-based compensation for personnel
−Removed: and consultants in executive, finance, business development, corporate communications and human resource functions, facility costs not
−Removed: otherwise included in research and development expenses, accounting and audit costs, tax compliance costs, SEC compliance costs, investor
−Removed: relation costs, training and conference costs, insurance costs and legal fees.
−Removed: significant portion of our operating expenses is related to stock-based compensation costs.
−Removed: Stock-based compensation costs were approximately
−Removed: $1.6 million and $2.2 million for the years ended December 31, 2024 and 2023, respectively.
−Removed: compensation consists of restricted stock units (“RSU”), restricted stock awards (“RSA”) and options to purchase
−Removed: shares of the Company’s common stock.
−Removed: The Company follows Accounting Standards Codification (“ASC”) 718, Compensation
−Removed: - Stock Compensation, which addresses the accounting for stock-based payment transactions, requiring such transactions to be accounted
−Removed: for using the fair value method.
−Removed: The fair value of RSU or RSA awards is determined by the closing price per share of the Company’s
−Removed: common stock on the date of the award.
−Removed: The Company uses the Black-Scholes option pricing model to determine the grant date fair value
−Removed: of options issued.
−Removed: and RSU’s may contain vesting conditions that include, without limitation, any or all of the following:
−Removed: immediate vesting, vesting
−Removed: over a defined time period, vesting based on specific volume weighted average price levels being achieved by the Company’s common
−Removed: stock as publicly traded within specified measurement periods, and vesting based on the achievement of specific performance milestones.
+Added: We utilize a combination of internal
+Added: and external efforts to advance product development from early-stage work to future clinical trial manufacturing and clinical trial support.
+Added: External efforts include work with consultants and increasingly substantial work at CROs and CMOs.
+Added: We support an internal research and
+Added: development team in Calgary, Alberta, Canada.
+Added: To move these programs forward along our development timelines, a large portion (approximately
+Added: 75%) of our staff are research and development employees.
+Added: In January 2024, the Company reduced its discovery team in Calgary and was primarily
+Added: focused on the development of EB-002 and EB-003 pipeline assets (until we out-licensed EB-002 to MycoMedica Lifesciences in November of
+Added: Because of the numerous risks and uncertainties associated with product development, however, we cannot determine with certainty
+Added: the duration and completion costs of these or other current or future preclinical studies and clinical trials.
+Added: The duration, costs and
+Added: timing of clinical trials and development of our product candidates will depend on a variety of factors, including the uncertainties of
+Added: future clinical and preclinical studies, uncertainties in clinical trial enrollment rates and significant and changing government regulation.
+Added: In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing
+Added: capability and commercial viability.
+Added: General and Administrative Expenses
+Added: General and administrative
+Added: expenses consist principally of salaries, benefits and related costs such as stock-based compensation for personnel and consultants in
+Added: executive, finance, business development, corporate communications and human resource functions, facility costs not otherwise included
+Added: in research and development expenses, accounting and audit costs, tax compliance costs, SEC compliance costs, investor relation costs,
+Added: training and conference costs, insurance costs and legal fees.
+Added: Stock-Based Compensation
+Added: A significant portion of our
+Added: operating expenses is related to stock-based compensation costs.
+Added: Stock-based compensation costs were approximately $0.8 million and $1.6
+Added: million for the years ended December 31, 2025 and 2024, respectively.
+Added: Stock-based compensation consists
+Added: of restricted stock units (“RSU”), restricted stock awards (“RSA”) and options to purchase shares of the Company’s
+Added: common stock.
+Added: The Company follows Accounting Standards Codification (“ASC”) 718, Compensation - Stock Compensation, which
+Added: addresses the accounting for stock-based payment transactions, requiring such transactions to be accounted for using the fair value method.
+Added: The fair value of RSU or RSA awards is determined by the closing price per share of the Company’s common stock on the date of the
+Added: The Company uses the Black-Scholes option pricing model to determine the grant date fair value of options issued.
+Added: RSA’s and RSU’s may
+Added: contain vesting conditions that include, without limitation, any or all of the following:
+Added: immediate vesting, vesting over a defined time
+Added: period, vesting based on specific volume weighted average price levels being achieved by the Company’s common stock as publicly
+Added: traded within specified measurement periods, and vesting based on the achievement of specific performance milestones.
+Added: RSUs may also contain
+Added: certain delivery conditions including, without limitation, delivery conditioned on change in control or termination of services for any
+Added: reason other than for cause.
Options contain vesting conditions that provide for vesting over a defined time period.
−Removed: fair value of RSA’s and RSU’s and options, is charged to expense, on a straight line basis over the vesting periods defined
−Removed: in the award agreements, except for the fair value which is attributable to achievement of a specific performance milestones, which are
−Removed: charged to expense upon achievement of such milestones.
−Removed: of Operations
−Removed: following table sets forth information comparing the components of net loss for the years ended December 31, 2024 and 2023:
−Removed: the Years Ended December 31,
−Removed: and administrative
−Removed: and development
−Removed: and amortization
+Added: The fair value of RSA’s and
+Added: RSU’s and options, is charged to expense, on a straight line basis over the vesting periods defined in the award agreements, except
+Added: for the fair value which is attributable to achievement of a specific performance milestones, which are charged to expense upon achievement
+Added: of such milestones.
+Added: Results of Operations
+Added: The following table sets forth information comparing
+Added: the components of net loss for the years ended December 31, 2025 and 2024:
+Added: For the Years Ended December 31,
Operating expenses
−Removed: from operations
−Removed: (16,448,440 )
−Removed: income (expense)
−Removed: in fair value of warrant liabilities
−Removed: in fair value of investment option liability
−Removed: in fair value of derivative liability
+Added: General and administrative
+Added: Research and development
+Added: Depreciation and amortization
+Added: Total operating expenses
+Added: Loss from operations
Other income (expense)
−Removed: loss before income taxes
+Added: Interest (expense) income, net
+Added: Total other income
+Added: Net loss before income taxes
$ (8,771,987 )
$ (9,566,057 )
+Added: Income tax expense
$ (8,771,987 )
$ (9,574,987 )
−Removed: and Administrative Expenses
−Removed: general and administrative expenses decreased to $6,453,505 for the year ended December 31, 2024 from $8,852,021 for the year ended December
−Removed: 31, 2023, a decrease of $2,398,516, or 27%.
−Removed: This change was primarily driven by decreases in consulting expenses of $1,067,245, salaries
−Removed: and wages of $623,101, stock compensation expense of $508,785, accounting fees of $345,488, insurance expenses of $193,932, and software
−Removed: expenses of $183,681.
−Removed: This is offset by an increase in director fees of $223,700, public company fees of $182,643, and Delaware Franchise
−Removed: Tax expenses of $81,421.
−Removed: decrease in consulting fees was due to decreased outsourcing to contractors.
−Removed: The decrease in salaries and wages was due to the reduction
−Removed: The decrease in stock compensation expense was primarily to a reduction in expense related to restricted stock units as a result
−Removed: of forfeitures and decreased value of new grants as a result of lower stock prices.
−Removed: The decrease in accounting fees was due to a reduction
−Removed: in technical accounting services.
−Removed: The decrease in insurance expense was due to lower premiums as a result of lower payroll costs.
−Removed: decrease in software expenses was due to the down-size in operations of Enveric Canada.
−Removed: The increase in director fees was due to the
−Removed: addition of a director to the Board during 2024 and cash payments made to each director during the year.
−Removed: The increase in public company
−Removed: fees was due to an increase in broker fees and other public company filing fees.
−Removed: and Development Expenses
−Removed: research and development expense for the year ended December 31, 2024 was $2,841,272 as compared to $7,252,437 for the year ended December
−Removed: 31, 2023 with a decrease of $4,411,165, or approximately 61%.
−Removed: This decrease was primarily driven by decreased salaries and wages of $1,560,017,
−Removed: research costs of $1,346,647, CRO costs of $1,247,284, lab expenses of $158,514, tax incentive of $149,262, and rent of $86,098.
−Removed: decrease in salaries and wages was due to the reduction in force as a result of the Company’s cost reduction plan.
−Removed: in research costs and CRO costs was due to the completion of the Australia research and development project during the second quarter
−Removed: The decrease in lab expenses was due to a reduction in research and development during 2024.
−Removed: The decrease in tax incentives
−Removed: was due to a tax credit received during 2024.
−Removed: The decrease in rent was due to the expiration of the Company’s Canadian lease during
−Removed: These decreases were slightly offset by an increase in consulting fees of $366,060.
−Removed: The increase in consulting fees was due to
−Removed: certain employees that were hired on a part-time consultant basis to perform certain research and development activities.
−Removed: and Amortization Expense
−Removed: and amortization expense for the year ended December 31, 2024 was $337,489 as compared to $343,982 for the year ended December 31, 2023,
−Removed: with a decrease of $6,493, or approximately 2%.
−Removed: in Fair Value of Warrant Liabilities
−Removed: in fair value of warrant liabilities for the year ended December 31, 2024 resulted in income of $24,370 as compared to $94,396 for the
−Removed: year ended December 31, 2023.
−Removed: The change in fair value of warrant liabilities is significantly influenced by the change in the closing
−Removed: price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning of each period with
−Removed: a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock.
−Removed: The significant
−Removed: decrease in the Company’s stock price during the year ended December 31, 2024 compared to the year ended December 31, 2023, resulted
−Removed: in the significant decrease to the change in fair value of warrant liabilities.
−Removed: in Fair Value of Investment Option Liability
−Removed: in fair value of investment option liability for the year ended December 31, 2024 resulted in income of $21,620 as compared to $208,752
+Added: General and Administrative Expenses
+Added: Our general and administrative
+Added: expenses decreased to $5,792,573 for the year ended December 31, 2025 from $6,453,505 for the year ended December 31, 2024, a decrease
+Added: of $660,932, or 10%.
+Added: This change was primarily driven by decreases in legal fees of $262,077, director fees of $253,719, stock compensation
+Added: expense of $215,306, Delaware Franchise Tax expenses of $133,612, insurance expenses of $101,428, and consulting expenses of $70,179.
+Added: This is offset by an increase in marketing expenses of $433,654.
+Added: The decrease in legal fees
+Added: was due to deferred offering costs that were expensed during the year ended December 31, 2024 related to the Lincoln Park equity line.
+Added: The decrease in director fees was primarily due the mix of cash versus equity compensation, including the issuance of full equity awards
+Added: in 2025 rather than cash payments in lieu of shares.
+Added: The decrease in stock compensation expense was primarily to a reduction in expense
+Added: related to restricted stock units as a result of decreased value of new grants as a result of lower stock prices.
+Added: The decrease in Delaware
+Added: Franchise Tax expense was primarily due to higher expense in 2024 due to the Company filing an amended 2023 return during 2024.
+Added: in insurance expense was due to lower premiums as a result of lower payroll costs.
+Added: The decrease in consulting expense was due to decreased
+Added: outsourcing to contractors.
+Added: The increase in marketing expenses was due to increased digital marketing campaigns.
+Added: Research and Development Expenses
+Added: Our research and development
+Added: expense for the year ended December 31, 2025 was $2,781,017 as compared to $2,841,272 for the year ended December 31, 2024 with a decrease
+Added: of $60,255, or approximately 2%.
+Added: This decrease was primarily driven by decreased salaries and wages of $633,549, CRO costs, net of tax
+Added: incentives of $205,018, research costs of $380,159, lab expenses of $59,090, product development costs of $33,620, and rent of $28,143.
+Added: This is offset by an increase in consulting expenses of $1,311,430.
+Added: The decrease in salaries and
+Added: wages was due to the reduction in force as a result of the Company’s cost reduction plan.
+Added: The decrease in CRO costs and research costs
+Added: was due to the completion of the Australia research and development project during the second quarter of 2024.
+Added: The decrease in lab expenses
+Added: and product development costs was due to a reduction in research and development that began in 2024.
+Added: The decrease in rent was due to the
+Added: expiration of the Company’s Canadian lease during 2024.
+Added: The increase in consulting fees was due to certain employees that were hired on
+Added: a part-time consultant basis to perform certain research and development activities.
+Added: The increase in tax incentives was due to a tax credit
+Added: received during 2024.
+Added: Depreciation and Amortization Expense
+Added: Depreciation and amortization
+Added: expense for the year ended December 31, 2025 was $200,858 as compared to $337,489 for the year ended December 31, 2024, with a decrease
+Added: of $136,631, or approximately 40%, primarily related to full amortization of the Company’s intangible assets in the first quarter
+Added: Going Concern, Liquidity and Capital Resources
+Added: We have incurred a loss since
+Added: inception resulting in an accumulated deficit of $114,846,492 as of December 31, 2025 and further losses are anticipated in the development
+Added: of its business.
+Added: Further, we had operating cash outflows of $8,141,543 for the year ended December 31, 2025.
For the year ended December 31,
−Removed: The change in fair value of investment option liability is significantly influenced by the change
−Removed: in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning of
−Removed: each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock.
−Removed: The significant decrease in the Company’s stock price during the year ended December 31, 2024 compared to the year ended December
−Removed: 31, 2023, resulted in the significant decrease to the change in fair value of warrant liabilities.
−Removed: was no inducement expense for the year ended December 31, 2024 as compared to $1,848,235 for the year ended December 31, 2023.
−Removed: recorded were related to inducement incurred related to the conversion of warrants and investment options that occurred in December 2023.
−Removed: in Fair Value of Derivative Liability
−Removed: Company’s change in fair value of derivative liability is due to the May 2023 redemption which ceased the probability of occurrence
−Removed: of the Akos spin-off and Akos Series A Preferred Stock redemption.
−Removed: Company’s other income during the year ended December 31, 2024 relates to licensing income from the contract with MycoMedica Life
−Removed: Concern, Liquidity and Capital Resources
−Removed: Company has incurred a loss since inception resulting in an accumulated deficit of $106,074,505 as of December 31, 2024 and further losses
−Removed: are anticipated in the development of its business.
−Removed: Further, the Company had operating cash outflows of $7,726,139 for the year ended
−Removed: December 31, 2024.
−Removed: For the year ended December 31, 2024, the Company had a loss from operations of $9,632,266.
−Removed: Since inception, being
−Removed: a research and development company, the Company has not yet generated revenue and the Company has incurred continuing losses from its
−Removed: The Company’s operations have been funded principally through the issuance of debt and equity.
−Removed: These factors raise
−Removed: substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these
−Removed: financial statements.
−Removed: assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate
−Removed: sufficient cash flow in the future to support its operating and capital expenditure commitments.
−Removed: At December 31, 2024, the Company had
−Removed: cash of $2,241,026 and working capital of $1,244,848.
−Removed: The Company’s current cash on hand is insufficient to satisfy its operating
−Removed: cash needs for the 12 months following the filing of this Annual Report on Form 10-K.
−Removed: These conditions raise substantial doubt regarding
−Removed: the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued.
−Removed: Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public
−Removed: or private equity or debt financings or other sources, and may include additional collaborations with third parties as well as disciplined
−Removed: cash spending.
−Removed: Adequate additional financing may not be available to us on acceptable terms, or at all.
−Removed: Should the Company be unable
−Removed: to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing
−Removed: certain operating activities.
−Removed: a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as
−Removed: a going concern for a period of one year after the date of the financial statements.
−Removed: The Company’s consolidated financial statements
−Removed: do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: inception, we have primarily used our available cash to fund our product development and operations expenditures.
−Removed: Flows for the Years Ended December 31, 2024 and 2023
−Removed: following table sets forth a summary of cash flows for the years presented:
−Removed: the Years Ended December 31,
−Removed: cash used in operating activities
−Removed: $ (7,726,139 )
+Added: 2025, we had a loss from operations of $8,774,448.
+Added: Since inception, being a research and development company, we have not yet generated
+Added: revenue and have incurred continuing losses from our operations.
+Added: Our operations have been funded principally through the issuance of debt
+Added: These factors raise substantial doubt about tour ability to continue as a going concern for a period of one year from the
+Added: issuance of these financial statements.
+Added: In assessing our ability to
+Added: continue as a going concern, we monitor and analyze our cash and our ability to generate sufficient cash flow in the future to support
+Added: its operating and capital expenditure commitments.
+Added: At December 31, 2025, we had cash of $4,677,491 and working capital of $4,018,307.
+Added: Our current cash on hand is insufficient to satisfy its operating cash needs for the 12 months following the filing of this Annual Report.
+Added: These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date
+Added: the financial statements are issued.
+Added: Management’s plan to alleviate the conditions that raise substantial doubt include raising
+Added: additional working capital through public or private equity or debt financings or other sources, and may include additional collaborations
+Added: with third parties as well as disciplined cash spending.
+Added: Adequate additional financing may not be available to us on acceptable terms,
+Added: Should we be unable to raise sufficient additional capital, we may be required to undertake cost-cutting measures including
+Added: delaying or discontinuing certain operating activities.
+Added: Our consolidated financial statements do not include any adjustments that might
+Added: result from the outcome of this uncertainty.
+Added: Since inception, we have primarily
+Added: used our available cash to fund our product development and operations expenditures.
+Added: Cash Flows for the Years Ended December
+Added: 31, 2025 and 2024
+Added: The following table sets forth
+Added: a summary of cash flows for the years presented:
+Added: For the Years Ended December 31,
+Added: Net cash used in operating activities
$ (8,141,543 )
−Removed: cash provided by investing activities
−Removed: cash provided by (used in) financing activities
−Removed: of foreign exchange rate on changes on cash
−Removed: decrease in cash
$ (7,726,139 )
−Removed: cash used in operating activities was $7,726,139 during the year ended December 31, 2024, which consisted primarily of a net loss adjusted
−Removed: for non-cash items of $7,302,896, a decrease in prepaid expenses of $178,496, an increase in due to related parties of $232,891 and a
−Removed: decrease in accounts payable and accrued liabilities of $834,630.
−Removed: cash used in operating activities was $14,094,411 during the year ended December 31, 2023, which consisted primarily of a net loss adjusted
−Removed: for non-cash items of $13,919,661, an increase in prepaid expenses and other current assets of $6,857, a decrease in accounts payable
−Removed: and accrued liabilities of $103,848, and a decrease in right-of-use operating lease asset and obligation of $64,045.
−Removed: cash provided by investing activities was $0 during the year ended December 31, 2024.
−Removed: cash used in investing activities was $11,667 during the year ended December 31, 2023, which consisted of the purchase of property and
−Removed: equipment, offset by proceeds from sale of property and equipment.
−Removed: cash provided by financing activities was $7,673,834 during the year ended December 31, 2024, which consisted of $1,804,819 in proceeds
−Removed: from the subscription receivable related to issuance of Inducement Warrants and the exercise of warrants and preferred investment options,
−Removed: $2,676,980 in proceeds from the exercise of Inducement Warrants, $2,290,186 in proceeds from commons stock sold under the Distribution
−Removed: Agreement, net of offering costs, $1,083,706 in proceeds from common stock sold under the Purchase Agreement, net of offering costs,
−Removed: offset by the payment of offering costs previously accrued of $181,857.
−Removed: cash used in financing activities was $1,343,141 during the year ended December 31, 2023, which consisted of $1,052,057 for the redemption
−Removed: of Series A Preferred Stock and the payment of offering costs previously accrued of $291,084.
−Removed: Accounting Estimates
−Removed: management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial
−Removed: statements, which have been prepared in accordance with U.S.
+Added: Net cash provided by investing activities
+Added: Net cash provided by financing activities
+Added: Effect of foreign exchange rate on changes on cash
+Added: Net increase (decrease) in cash
+Added: Operating Activities
+Added: Net cash used in operating
+Added: activities was $8,141,543 during the year ended December 31, 2025, which consisted primarily of a net loss adjusted for non-cash items
+Added: of $7,845,601, a decrease in accounts payable, accrued expenses and other liabilities of $413,864, a decrease in due to related parties
+Added: of $133,016, and a decrease in prepaid expenses and other current assets of $250,938.
+Added: Net cash used in operating
+Added: activities was $7,726,139 during the year ended December 31, 2024, which consisted primarily of a net loss adjusted for non-cash items
+Added: of $7,302,896, a decrease in prepaid expenses and other current assets of $178,496, an increase in due to related parties of $232,891,
+Added: and a decrease in accounts payable, accrued expenses and other liabilities of $834,630.
+Added: Investing Activities
+Added: Net cash provided by investing
+Added: activities was $0 during the years ended December 31, 2025 and 2024.
+Added: Financing Activities
+Added: Net cash provided by financing
+Added: activities was $10,579,507 during the year ended December 31, 2025, which consisted of $4,698,241 in net proceeds from the exercise and
+Added: inducement of warrants, $4,244,467 in net proceeds from the exercise of Common Stock and warrants, net of offering costs, and $1,636,799
+Added: in net proceeds from Common Stock sold for cash pursuant to the ATM Agreement, net of offering costs.
+Added: Net cash provided by financing
+Added: activities was $7,673,834 during the year ended December 31, 2024, which consisted of $1,804,819 in net proceeds from the subscription
+Added: receivable related to issuance of Inducement Warrants and the exercise of warrants and preferred investment options, $2,676,980 in net
+Added: proceeds from the exercise of Inducement Warrants, $2,290,186 in net proceeds from commons stock sold under the Distribution Agreement,
+Added: net of offering costs, $1,083,706 in net proceeds from common stock sold under the Purchase Agreement, net of offering costs, offset by
+Added: the payment of offering costs previously accrued of $181,857.
+Added: Critical Accounting Estimates
+Added: Our management’s discussion
+Added: and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared
+Added: in accordance with U.S.
generally accepted accounting principles (“GAAP”).
−Removed: The preparation
−Removed: of our consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect
−Removed: the reported amount of assets, liabilities, costs and expenses and related disclosures.
−Removed: Our critical accounting estimates are those estimates
−Removed: that involve a significant level of uncertainty at the time the estimate was made, and changes in them have had or are reasonably likely
−Removed: to have a material effect on our financial condition or results of operations.
−Removed: Accordingly, actual results could differ materially from
−Removed: our estimates.
−Removed: We base our estimates on past experience and other assumptions that we believe are reasonable under the circumstances,
−Removed: and we evaluate these estimates on an ongoing basis.
−Removed: Significant areas requiring management’s estimates and assumptions include
−Removed: determining the fair value of transactions involving common stock, the valuation of warrants and preferred investment options, the valuation
−Removed: of stock-based compensation and accruals associated with third party providers supporting research and development efforts.
−Removed: Actual results
−Removed: could differ from those estimates.
+Added: The preparation of our consolidated financial statements
+Added: and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities,
+Added: costs and expenses and related disclosures.
+Added: Our critical accounting estimates are those estimates that involve a significant level of
+Added: uncertainty at the time the estimate was made, and changes in them have had or are reasonably likely to have a material effect on our
+Added: financial condition or results of operations.
+Added: Accordingly, actual results could differ materially from our estimates.
+Added: We base our estimates
+Added: on past experience and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an
+Added: ongoing basis.
+Added: Significant areas requiring management’s estimates and assumptions include determining the fair value of transactions
+Added: involving common stock, and the valuation of warrants.
+Added: Actual results could differ from those estimates.
+Added: The Company did not have any
+Added: critical accounting estimates for the year ended December 31, 2025.
+Added: Quantitative and Qualitative Disclosures
+Added: About Market Risk
+Added: Not applicable.
+Added: Financial Statements and Supplementary
+Added: The information required by
+Added: this Item 8 is incorporated by reference to this Annual Report beginning on page F-1.
+Added: Changes in and Disagreements with Accountants
+Added: on Accounting and Financial Disclosure
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.