The following Management's Discussion and Analysis of Financial Condition and Results of Operations describes the principal factors affecting the results of operations, liquidity and capital resources of the Company and critical accounting estimates. This discussion should be read in conjunction with the accompanying quarterly unaudited Condensed Consolidated Financial Statements contained in this Form 10-Q and our Annual Report on Form 10-K, for the year endedMarch 31, 2021 ("Annual Report"). Our Annual Report includes additional information about our significant accounting policies, practices and the transactions that underlie our financial results, as well as a detailed discussion of the most significant risks and uncertainties associated with our financial and operating results. This Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements are often identified by the use of words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate," or "continue," and similar expressions or variations. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled "Risk Factors", set forth in Part II, Item 1A of this Form 10-Q and in our otherSEC filings. We disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Business OverviewTauriga Sciences, Inc. (the "Company") is aFlorida corporation, with its principal place of business being located at4 Nancy Court , Suite 4,Wappingers Falls, NY 12590. The Company has, over time, moved into a diversified life sciences technology company, with its mission to operate a revenue generating business, while continuing to evaluate potential acquisition candidates operating in the life sciences technology space.Tauriga Pharma Corp. OnJanuary 4, 2018 , the Company announced the formation of a wholly owned subsidiary inDelaware , now known asTauriga Pharma Corp. This subsidiary's focus is on the development of a pharmaceutical product line that is synergistic with the Company's primary CBD product line. Currently, the plan is to initially create a pharmaceutical line of products to address nausea symptoms related to chemotherapy treatment in patients, which we will submit for clinical trials and to regulatory agencies for approval. OnMarch 18, 2020 , the Company filed a ProvisionalU.S. Patent Application covering its pharmaceutical grade version of Tauri-Gum™. This patent application, filed with the United States Patent & Trademark Office ("U.S.P.T.O."), titled: "MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT." The Company's proposed pharmaceutical grade version of Tauri-Gum™ is being developed for nausea regulation, intended specifically to target patients subjected to ongoing chemotherapy treatment(s) (the "Indication"). The delivery system for this pharmaceutical product is an improved version of the existing "Tauri-Gum™" chewing gum formulation based on continued research and development. The Company converted this provisional patent application into aU.S. Non-Provisional Patent ApplicationMarch 17, 2021 .
On
OnMarch 17, 2021 , the Company filed an International Patent Application under the Patent Cooperation Treaty ("PCT"), a cooperative agreement entered into by more than 130 countries with the purpose of bringing international conformity to the filing and preliminary evaluation of patent applications. This application relates to the Company's proposed pharmaceutical cannabinoid chewing gum delivery system being developed to treat nausea derived from active chemotherapy treatment. The PCT application is published by theInternational Bureau at theWorld Intellectual Property Organization ("WIPO"), based inGeneva, Switzerland , in one of the ten "languages of publication": Arabic, Chinese, English, French, German, Japanese, Korean, Portuguese, Russian, and Spanish.
Currently, the pharmaceutical grade version of I is in the pre-IND stage of development. The development team is working on several parallel workstreams, including:
? formulation development;
? non-clinical in vivo and in vitro studies to inform the effective clinical dose
and safety margin;
? regulatory strategy and regulatory documentation preparation;
? confirmation of the active pharmaceutical ingredient (API); and
? Identifying pharma-grade API suppliers.
3NFTauriga Corp. EffectiveApril 14, 2021 , the Company formedNFTauriga Corp. in theState of Delaware , as a wholly owned subsidiary. The Company is the sole holder of total authorized 100 shares having a par value of$0.00001 . The Company's Chief Executive Officer,Seth M. Shaw is the initial sole member of the board of directors, to serve until a qualified successor is duly elected.Mr. Shaw will also serve as the Chief Executive Officer and Secretary. The registered office ofNFTauriga Corp. in theState of Delaware shall be at1013 Centre Road , Suite 403-B,Wilmington, DE 19805 in the County ofNew Castle . The name of its registered agent at such address isVcorp Services, LLC .NFTauriga Corp. will have the same fiscal year and principal executive office and the Company. Master Services Agreement
OnDecember 16, 2020 , the Company entered into a Master Services Agreement withNorth Carolina basedClinical Strategies & Tactics, Inc. ("CSTI") to resume the clinical development of its proposed anti-nausea pharmaceutical grade version of Tauri-Gum™. CSTI will primarily focus its efforts on (i) Pharmaceutical Development Strategy, (ii) Commercialization Strategy, and (iii) Funding Strategy. The Company will with work with CSTI's founder and chief executive officer,JoAnn C. Giannone .Ms. Giannone has over 25 years' experience effectively leading companies through the drug and medical device development process. OnDecember 23, 2020 , the Company funded the initial consulting fees associated with this Agreement, in the amount of$67,500 , exclusive of out-of-pocket reimbursable expenses. The Company has paid additional fees, effected through change orders to the original contract, in the amount of$85,000 . These additional fees were for pharmaceutical testing and market research. Under the terms of the Agreement and related statement of work,CTSI will provide a high-level assessment and documentation of the development efforts required to commercialize the proposed pharmaceutical product globally, a commercial assessment, and a review of potential funding strategies and funding sources and potential business partners. The delivery system for this proposed pharmaceutical version is a modified version (with higher concentration of CBD) of the existing Tauri-Gum™" chewing gum formulation based on continued research and development. As ofDecember 31, 2021 ,$2,536 of contract payments were recorded as prepaid expense for services yet to be rendered. COMPANY PRODUCTS Tauri-GumTM
In lateDecember 2018 , the Company entered into a "Manufacturing Agreement" withMaryland based chewing gum manufacturer,Per Os Biosciences LLC ("Per Os Bio") to launch a white label line of CBD infused chewing gum under the brand name Tauri-GumTM. The Manufacturing Agreement with Per Os Bio to produce Tauri-GumTM initially consisted of 10mg of CBD isolate for its inaugural mint flavor. This proprietary CBD Gum will be manufactured underU.S. Patent # 9,744,128 ("Method for manufacturing medicated chewing gum without cooling"). Each production batch is tested by a 3rd Party for CBD label content, THC content (0%), and clear for microbiology. The retail packaging consists of an 8-piece blister card labeled with lot number and expiration date. InOctober 2019 , we also filed trademark applications for the above-referenced marks in each of theEuropean Union andCanada . The Company received notice of allowance from the European Union Intellectual Property Office granting the Company its trademark registration for Tauri-Gum™ (E.U. Trademark # 018138334) onFebruary 18, 2020 . During fiscal year 2020, the Company commenced development of a cannabigerol "CBG" isolate infused version of Tauri-Gum™ introducing Peach-Lemon flavor (containing 10mg CBG per piece) and Black Currant Flavor (containing 15mg of CBG per piece).
During fiscal year 2021, the Company developed an Immune Booster version of Tauri-Gum™ chewing gum. This product contains 60mg of Vitamin C and 10mg of Elemental Zinc per piece. This product does not contain any phytocannabinoids (i.e., CBD or CBG). During fiscal year 2021, the Company enhanced its original Tauri-Gum™ formulation by increasing the infusion concentrations of both its Cannabidiol ("CBD") and Cannabigerol ("CBG") Tauri-Gum™ products to 25mg per piece of chewing gum (previous concentration was 10mg for the Pomegranate, Blood Orange, Mint, and Peach-Lemon flavors and 15mg for the Black Currant flavor). Additionally, the Company increased its Tauri-Gum™ product offerings to 9 SKUs. The new offerings being introduced areCherry-Lime Rickey flavored Caffeine infused chewing gum, an 8-piece blister pack of containing 50mg of caffeine per piece andGolden Raspberry flavored Vitamin D3 infused chewing gum, containing 2,000 IU (50 micrograms) of Vitamin D3 per piece. Through itsOctober 2020 partnership withThink Big LLC (the Company founded by the son of late iconicU.S. rap artist, NOTORIOUS BIG aka "Frank White"), the Company is also offering 2 limited edition Licensed Tauri-Gum™/Frank White products: Honey-Lemon flavored chewing gum (containing: 15mg CBD, 15mg CBG, 5mg Vitamin C, 10mg Zinc per piece) and Mint flavor (25mg CBD per piece). 4
Delta 8 Version of Tauri-GumTM
DuringMarch 2021 , the Company developed a Delta-8-Tetrahydrocannabinol ("Delta-8-THC" or "Delta-8") infused version of Tauri-Gum™. Delta-8-THC infused products are legal when the ingredient has been derived from the industrial hemp plant ("Cannabis Sativa") and does not contain more than 0.3% (1/333rd by dry weight composition) THC. The Company is focused on expanding both its product offerings and revenue opportunities, in a manner that is ethical, innovative, and fully compliant with Federal laws & regulations. Due to strong indications of demand, the Company has completed a double production run of its Evergreen Mint flavor, Delta 8 THC infused (10mg per piece of chewing gum), Version of Tauri-Gum™. All of the CBD/CBG Tauri-GumTM skus are made in theUSA , formulations are allergen free, gluten free, vegan, kosher certified (K-Star ), Halal certified (Etimad), non-GMO, vegan incorporated by a proprietary lab-tested manufacturing process.
See our "Risk Factors" contained in our Annual Report datedMarch 31, 2021 filed with theSecurities and Exchange Commission onJune 29, 2021 , including with respect, but not limited, to Federal laws and regulations that govern CBD and cannabis, and any such updated risk factors included in this periodic report. Tauri-Gummies™ OnNovember 25, 2019 , the Company announced that it has finalized the formulation for its Vegan 25 mg CBD (Isolate) Infused Gummies product to be branded Tauri-Gummies™ for which a trademark was filed inSwitzerland and theEuropean Union . The company has received a Notice of Allowance from the European Union Intellectual Property Office ("E.U.I.P.O.") granting the Company its trademark Registration for: Tauri-Gummies™ (E.U. Trademark # 018138348), effectiveJune 24, 2020 . This Notice of Allowance extends our protective period for this mark untilOctober 2029 and may be extended thereafter for ten-year intervals. This gelatin free, plant-based, Vegan and Kosher certified formulation contains 24 gummies per jar, 6 of each flavor (cherry, orange, lemon and lime). Each gummy contains 25mg of CBD isolate (600 mg of CBD isolate per jar). These gum drops have been manufactured in the "Nostalgic" 1950s confectionary style. The Company commenced sales of Tauri-Gummies™ inJanuary 2020 . Other Products The Company, from time to time, will offer various formats of CBD product through its e-commerce website. As of this report date the Company is currently offering a 70% dark chocolate 30mg CBD non-GMO dietary supplement and 100mg CBD scented bath bombs (Mint, Pomegranate, Blood Orange, Black Currant). The Company also offers 100mg CDG infused Peach/Lemon bath bombs as well as a D3 infusedGolden Raspberry andCherry Lime Rickey caffeine infused bath bombs. The Company's current offering includes a line of skin care products sold on its ecommerce website under the product line name of Uncle Bud's. The skin care products include three different 4.2mg CBD facemasks (collagen, detoxifying and tightening masks), 100mg CBD daily moisturizer, 30mg CBD anti-wrinkle dream, hand and foot cream with hemp seed oil, 120mg CBD massage and body oil, 240mg CBD body revive roll-on, 35mg CBD transdermal patch and 120mg CBD body spray. The Company also offers Tauri-Pet dog food in three flavors (peanut butter, butternut squash and crispy apple. OnJuly 12, 2021 , the Company announced two new topical products; CBD infused Sunscreen Spray and Acai Fragrance Moisturizing Lip Balm. These two products will be manufactured, under Tauri-Sun™ brand name. Tauri-Sun™ Sunscreen Spray has a 30 SPF (sun protection factor) and is infused 200mg of CBD isolate per 3-ounce container. The easy to use "Spray On" delivery system is hypoallergenic and environmentally responsible (Reef Friendly). The Tauri-Sun™ Acai Fragrance Moisturizing Lip Balm has a 30 Sun Protection Factor ("SPF") is dermatologist tested and CBD infused. OnJanuary 3, 2022 , we filed Trademark applications inthe United States and theEuropean Union for marks for each of TAURI-PET and TAURI-SUN. A notice of Allowance was granted by theEuropean Union Intellectual Property Office for the use of TAURI-SUN onJanuary 25, 2022 , registration Serial No. 018567792. We await a further Notice of Allowance or comment upon Tauri-Pet andTauri-Sun from each of the United States Patent and Trademark Office and the European Union Intellectual Property Office (other than the granted EU registration
forTauri-Sun noted above).
For a full list of our currently available products please visit our e-Commerce website at https://taurigum.com/.
DISTRIBUTION OF THE COMPANY'S PRODUCTS
Think BIG, LLC License Agreement
OnSeptember 24, 2020 , we entered into (i) a License Agreement ("License") withThink BIG, LLC , aLos Angeles based company ("Think BIG"), (ii) a Professional Services Agreement (the "PSA") withWillie C. Mack , Jr., CEO of Think BIG and (iii) a Professional Services Agreement ("PSA 2") withChristopher J. Wallace , a co-founder of Think BIG (each ofWillie C. Mack , Jr. andChristopher J. Wallace referred to herein as a "Brand Ambassador"), with the collective intent to enhance sales and marketing of the Company's product lines, including its proprietary Rainbow Deluxe Sampler Pack ("Rainbow Pack"), and any co-branded products created by the parties to the License and each of the PSAs (the "Co-Branded Products"). The term of this license is for a period of two years fromSeptember 24, 2020 (the "Effective Date"), unless earlier terminated by either party pursuant to the terms thereunder. The term of each of the PSA and the PSA 2 shall commence on the Effective Date and end on the earlier of (i) the two-year anniversary thereof; (ii) the termination for any reason of the License; or (iii) the earlier termination of the PSA Agreement pursuant to the terms thereunder.
5 The licensing arrangement permits for cross licensing, brand building, e-commerce customer acquisition efforts, retail customer acquisition efforts, enhanced social media presence, public relations & visibility strategies, as well as potential outreach to celebrities, and various other types of in-kind services in order to increase both Company revenue and customer acquisition efforts. The License will also allow for future joint development projects that will leverage the iconic "Frank White" brand and likeness/intellectual property (to which Think Big has the intellectual property rights). The Companies further agreed to a 50/50 gross profit split on sales of specially branded product, payable on or before the 15th day of each calendar month for the immediately preceding calendar month. In addition, the Company originally agreed to pay Think BIG, via a quarterly marketing fee for a period of twelve months in the amount$15,000 per quarter (for an aggregate total of$60,000 ), the first payment of which was paid by the Company within 10 days of the entry into the License. Subsequently, the parties agreed that the remaining payments would no longer be paid to Think BIG in exchange for the Company funding specially branded inventory printing and product as well as other marketing initiatives. Under each of the PSA and the PSA 2, each Brand Ambassador shall provide promotional and marketing services ("Services") to the Company during the term of the respective PSAs, subject to the terms and conditions set forth therein, in connection with the Co-Branded Products and any co-developed products; and perform their individual marketing and promotional services set forth under the PSA and the PSA 2, respectively, and each of the exhibits annexed thereto. As consideration for each Brand Ambassador's Services set forth under their respective PSAs, the Company agreed to issue each Brand Ambassador 1,500,000 restricted shares of the Company's common stock, upon execution of the PSA and PSA 2. These shares were issued onDecember 17, 2020 . Under the PSA's, the Company had initially agreed, following the one-year anniversary of the Effective Date, an additional 1,500,000 restricted shares of Company's common stock could be issued to each Brand Ambassador, subject to the satisfaction of the terms of such additional services and/or criteria to be mutually agreed upon by the parties to the PSA and/or the PSA 2. The Company has determined that these additional shares will not be paid. The value of all shares issued and to be issued had a value of$183,600 that will be recognized over the term of the contract. This agreement is still in effect as the Company is still selling this co-branded product. ThroughDecember 31, 2021 , the Company has recognized approximately$1,122 of sales of co-branded product.
Stock Up Express Agreement
EffectiveFebruary 1, 2021 , the Company entered into a distribution agreement withConnecticut based Stock Up Express, a division ofBozzuto's Inc. , a distributor that generates more than$3 Billion in annual sales. The agreement shall remain in effect for a period of two (2) years, with automatic renewal for additional successive one (1) year terms. Under terms of this distribution agreement, Stock Up Express will market and resell the Company's flagship brand, Tauri-Gum™, to its customer base of wholesale and retail customers in the mainlandUnited States . The two companies will jointly market Tauri-Gum™ to Stock Up Express' customer base. The Agreement allows for modification of product offerings, and the Company expects to offer additional product items over the course of calendar year 2021. Either party may terminate this Agreement for convenience by giving a sixty (60) day written notice to the other party or either party has the right to terminate this agreement if the other party breaches or is in default of any obligation hereunder, including the failure to make any payment when due, which default is incapable of cure or which, being capable of cure, has not been cured within thirty (30) days after receipt of written notice from the non-defaulting party or within such additional cure period as the non-defaulting party may authorize in writing. As ofDecember 31, 2021 , the Company has recognized no sales under this agreement. The Company has entered into multiple other arrangements that are more fully described and annexed thereto in our annual report, and such other subsequent periodic and current reports that we have filed with theSecurities and Exchange Commission , which agreements are filed to such reports and incorporated by
reference hereto and thereto. REGULATORY MATTERS
OnMay 31, 2019 , theU. S. Food and Drug Administration ("FDA") held public hearings to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds, including CBD. The hearing came approximately five months after the Agricultural Improvement Act of 2018 (more commonly known as the Farm Bill), went into effect and removed industrial hemp from the Schedule I prohibition under the Controlled Substances Act (CSA) (industrial hemp means cannabis plants and derivatives that contain no more than 0.3 percent tetrahydrocannabinol, or THC, on a dry weight basis). Though the Farm Bill removed industrial hemp from the Schedule I list, the Farm Bill preserved the regulatory authority of the FDA over cannabis and cannabis-derived compounds used in food and pharmaceutical products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. The FDA has been clear that it intends to use this authority to regulate cannabis and cannabis-derived products, including CBD, in the same manner as any other food or drug ingredient. In addition to holding the hearing, the agency had requested comments byJuly 2, 2019 regarding any health and safety risks of CBD use, and how products containing CBD are currently produced and marketed, which comment period was concluded onJuly 16, 2019 . As of the date hereof, the FDA has taken the position that it is unlawful to put into interstate commerce food products containing hemp derived CBD, or to market CBD as, or in, a dietary supplement. 6 Furthermore, since the closure of the FDA hearings on this issue, some state and local agencies have issued a ban on the sale of any food or beverages containing CBD. There have been legislative efforts at the federal level, which seek to provide clear guidance to industry stakeholders regarding how to comply with applicable FDA law with respect to CBD and other hemp derived cannabinoids. However, such legislative efforts have been limited and as of this date, these legislative efforts require extensive further approvals, including approval from both houses ofCongress and the President ofthe United States , before being enacted into law, if at all. Furthermore, with respect to Company's developing CBG and additional cannabinoid product lines, the FDA has provided no guidance as to how cannabinoids other than CBD (such as CBG) shall be regulated under the FD&C Act, and it is unclear at this time how such potential regulation could affect the results of the operations or prospects of the Company or this product line.
FDA Clinical Trial Process - United States Drug Development
Inthe United States , the FDA regulates drugs, medical devices and combinations of drugs and devices, or combination products, under the FDCA and its implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicableU.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include, among other actions, theFDA's refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, requests for voluntary product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.
The process required by the FDA before a drug may be marketed in
? completion of extensive pre-clinical in vitro and animal studies to evaluate safety and pharmacodynamic effects, formulation development, analytical method development, and manufacturing of the active pharmaceutical ingredient (API) and drug product for clinical trials in accordance with applicable regulations, including theFDA's Current Good Laboratory Practice (cGLP) regulations and Current Good Manufacturing Practice (cGMP) regulations;
? submission to the FDA of an Investigational New Drug (IND) application, which must become effective before human clinical trials may begin;
? performance of adequate and well-controlled human clinical trials in accordance with an applicable IND and other clinical study related regulations, sometimes referred to as Current Good Clinical Practice (cGCPs), to establish the safety and efficacy of the proposed drug for its proposed indication, and API and drug product scale-up for registration batch production and stability;
? submission to the FDA of a New Drug Application (NDA);
? satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with theFDA's cGMP requirements;
? potential FDA audit of the clinical trial sites that generated the data in support of the NDA; and
? FDA review and approval of the NDA prior to any commercial marketing or sale.
Once a pharmaceutical product candidate is identified for development, it enters the pre-clinical testing stage. Pre-clinical tests include laboratory evaluations of product characterization, drug product formulation development and stability, as well as pharmacology and toxicology animal studies. An IND Sponsor must submit the results of the pre-clinical tests, together with manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND. The sponsor must also include a protocol detailing, among other things, the objectives of the initial clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation. Some pre-clinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions related to a proposed clinical trial and places the trial on a clinical hold within that 30-day period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during clinical trials due to safety concerns or non-compliance and may be imposed on all drug products within a certain class of drugs. The FDA also can impose partial clinical holds, for example, prohibiting the initiation of clinical trials of a certain duration or for
a certain dose.
All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCP regulations. These regulations include the requirement that all research subjects provide informed consent in writing before their participation in any clinical trial. Further, an IRB must review and approve the plan for any clinical trial before it commences at any institution, and the IRB must conduct continuing review and reapprove the study at least annually. An IRB considers, among other things, whether the risks to individuals participating in the clinical trial are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal Representative and must monitor the clinical trial until completed. 7
Each new clinical protocol and any amendments to the protocol must be submitted for FDA review, and to the IRBs for approval. Protocols detail, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety.
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined. The phases are described below. For the TAUG Pharma product, however, the safety profile of the API is known, and a Phase 1 program is not expected. Therefore, it is anticipated that that the first-time-in-human (FTIH) study will be a Phase 2 study. ? Phase 1. The product is initially introduced into a small number of healthy human subjects or patients and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion and if possible, to gain early evidence on effectiveness. In the case of some products for severe or life-threatening diseases, especially when the product is suspected or known to be unavoidably toxic, the initial human testing may be conducted in patients. ? Phase 2. Involves clinical trials in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage and schedule. ? Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit relationship of the product and provide an adequate basis for product labeling.
Post-approval trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 trials. Companies that conduct certain clinical trials also are required to register them and post the results of completed clinical trials on a government-sponsored database, such as ClinicalTrials.gov inthe United States , within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions. Progress reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events, findings from other studies that suggest a significant risk to humans exposed to the product, findings from animal or in vitro testing that suggest a significant risk to human subjects, and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or Investigator Brochure. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. The FDA or the clinical trial Sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB's requirements or if the product has been associated with unexpected serious harm to patients. Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This group provides authorization for whether a trial may move forward at designated check points based on access to certain data from the study. The clinical trial Sponsor may also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate. The manufacturing process must be capable of consistently producing quality batches of the product candidate and among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
NDA and FDA Review Process The results of product development, pre-clinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the drug, proposed labeling and other relevant information, are submitted to the FDA as part of an NDA for a new drug, requesting approval to market the product. The submission of an NDA is subject to the payment of a substantial user fee, and the sponsor of an approved NDA is also subject to an annual program user fee; although a waiver of such fee may be obtained under certain limited circumstances. For example, the agency will waive the application fee for the first human drug application that a small business or its affiliate submits for review. The FDA reviews all NDAs submitted before it accepts them for filing and may request additional information rather than accepting an NDA for filing. The FDA typically makes a decision on accepting an NDA for filing within 60 days of receipt. The decision to accept the NDA for filing means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act ("PDUFA"), theFDA's goal to complete its substantive review of a standard NDA and respond to the applicant is ten months from the receipt of the NDA. The FDA does not always meet its PDUFA goal dates, and the review process is often significantly extended by FDA requests for additional information or clarification and may go through multiple review
cycles. 8
After the NDA submission is accepted for filing, the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended use, and whether the product is being manufactured in accordance with cGMPs to assure and preserve the product's identity, strength, quality and purity. The FDA may refer applications for novel drug products or drug products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. The FDA will likely re-analyze the clinical trial data, which could result in extensive discussions between the FDA and us during the review process. The review and evaluation of an NDA by the FDA is extensive and time consuming and may take longer than originally planned to complete, and we may not receive a timely approval, if at all. Before approving an NDA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMPs. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. In addition, before approving an NDA, the FDA may also audit data from clinical trials to ensure compliance with GCP requirements. After the FDA evaluates the application, manufacturing process and manufacturing facilities, it may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application will not be approved in its present form. A Complete Response Letter usually describes all the specific deficiencies in the NDA identified by the FDA. The Complete Response Letter may require additional clinical data and/or an additional pivotal Phase 3 clinical trial(s), and/or other significant and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing. If a Complete Response Letter is issued, the applicant may either resubmit the NDA, addressing all the deficiencies identified in the letter, or withdraw the application. Even if such data and information are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive, and the FDA may interpret data differently than the Sponsor interprets the same data.
The New York State Department of Health (NYDPH) has begun implementing regulations concerning the processing and retail sale of hemp derived cannabinoids. Under the regulations, "cannabinoid" is broadly defined as "any phytocannabinoid found in hemp, including but not limited to, Tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabielsoin (CBE), cannabicitran (CBT).
These regulations came into effect onJanuary 1, 2021 , and all "cannabinoid hemp processors" and "cannabinoid hemp retailers" operating within the state ofNew York must be licensed by the NYDPH. The regulations expressly allow for food and beverages to contain "cannabinoids", so long as such products meet certain requirements. To this end, the Company has submitted its license application with the NYDPH in compliance with this legislation. These regulations are evolving and the NYDPH recently issued a set of regulations to address the use of industrial hemp derived ?8- Tetrahydrocannabinol (?8 THC) and ?10- Tetrahydrocannabinol (?10 THC) in cannabinoid hemp products manufactured and sold inNew York .
The product requirements under the current regulations, include but are not limited to: the product must not contain more than 0.3% total ?9- Tetrahydrocannabinol concentration; the product must not contain tobacco or alcohol; the product must not be in the form of an injectable, transdermal patch, inhaler, suppository, flower product including cigarette, cigar or pre-roll, or any other disallowed form as determined by the NYDPH; if the product is sold as a food or beverage product, it must not have more than 25mg of cannabinoids per product; and if sold as an inhalable cannabinoid hemp product, the product will be subject to a number of additional safety measures.
Furthermore, all cannabinoid products sold at retail are subject to a series of labeling requirements. All such products must be labeled with the amount of cannabinoids in the product and the amount of milligrams per serving. If the product contains THC, the amount of THC in the product needs to be stated on the label in milligrams on a per serving and per package basis. In addition, all products are required to have a scannable bar code or QR code which links to a certificate of analysis and the packaging is prohibited from being attractive to consumers under 18 years of age. Products are also required to list appropriate warnings for consumer awareness. The Company's entire product line will comply with the above standards.
See our Risk Factors and going concern opinion in this report for more information about these items, as well as certain related disclosures included our Results of Operations under the heading "Going Concern".
The Company's activities are subject to significant risks and uncertainties, including failing to secure additional funding, success in developing and marketing its products and the level of competition and potential regulatory enforcement actions. These risks and others are described in greater detail in the Risk Factors set forth in this periodic report and our annual reports that we have filed and will also file in the future. 9 OTHER BUSINESS ITEMS
Nausea Derived from Active Chemotherapy Treatment
The Company announced that it has progressed development efforts on its ongoing pharmaceutical development project to deliver an Rx product (TAU 413) to treat Nausea Derived from Active Chemotherapy Treatment. The Company plans to perform in vitro studies with TAU 413 during the next quarter. In vivo testing and product formulation development will follow. If these efforts are successful, and funding is secured, the company intends to submit an IND during 2022. OnOctober 6, 2021 , the Company announced that it has received notification from the Patent Cooperation Treaty ("PCT") that its International Patent Application (App No. PCT/US21/22668) was Published (Publication No. WO2021/188612) onSeptember 23, 2021 . This International Patent Application was filed by the Company onMarch 17, 2021 as is Titled: MEDICATED CANNABINOID COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT. This International Patent Application relates to the Company's proposed Pharmaceutical, Cannabinoid based, Chewing Gum product (Sublingual Absorption - Delivery System) under development for the treatment of: Nausea Derived from Active Chemotherapy Treatment. OnNovember 1, 2021 the Company received Notice of Publication fromU.S. Patent and Trademark Office ("USPTO"), for itsU.S. Patent Application No. 17/204,106. The Company filed thisU.S. Patent Application onMarch 17, 2021 and its related to its ongoing pharmaceutical development efforts.
Strategic Marketing and Consulting Agreement with
OnJune 14, 2021 , the Company entered into a 12-month Strategic Marketing and Consulting Agreement withMayer & Associates . Under this agreement the Company will paid$150,000 as well as the issuance of 3,500,000 shares of restricted common shares of Company stock. Half of the cash payment ($75,000 ) was paid upon execution of this agreement and the other half was paid approximately 90 days thereafter. Upon execution, the Company issued 2,200,000 of the above-mentioned shares. The remaining 1,300,000 above-mentioned shares were issued approximately 90 days after this contract was executed.Mayer and Associates will provide the Company with opportunities relating to the world of professional sports, with respect to its products and product lines. This includes, but is not limited to, introductions to professional sports leagues, celebrity (professional athletes) influencers/brand ambassadors/brand liaison(s), research and development opportunities, hosting of small periodic events for the Company and a diversified group of high-profile contacts and relationships, use social media exposure, podcasts backing of various elements from professional sports as well as assist the Company in advising of potential merger partners and developing corporate partnering relationships. The Company, at the sole discretion of its board, may pay an additional payment of$75,000 as permitted under this agreement based on performance. This additional payment will be recorded as a contingent liability on the Company condensed consolidated balance sheet until formally authorized by the Company's board of directors. This agreement is terminable after six months. As of the date of this quarterly report date, the aforementioned shares have been issued. RESULTS OF OPERATIONS
For the three and nine months ended
The results of operations included herein contain only those operations that are part of our continuing operations. For discussion regarding our past operations which have since been disposed of, please refer to our Annual Report. Net Revenue
During the three months endedDecember 31, 2021 , the Company recognized net revenue of$102,580 . Net revenues for the three months endedDecember 31, 2020 were$74,949 . All of the Company's sales came from online and wholesale clients. For the purposes of sales by sales channel segmentation, distributor sales include sales to customers that were distributors. During the nine months endedDecember 31, 2021 , the Company recognized net revenue of$243,293 . Net revenues for the nine months endedDecember 31, 2020 were$215,113 . The Company's sales came from online and wholesale clients. For the purposes of sales by sales channel segmentation, distributor sales include sales to customers that were distributors.
Sales by sales channel for the three and nine months ended
For the three months ended For the nine months ended December 31, December 31, 2021 2020 2021 2020 Revenue: Distributor $ - $ - $ - $ - E-Commerce 98,356 72,939 196,818 169,428 Wholesale 4,224 2,010 46,475 45,685$ 102,580 $ 74,949 $ 243,293 $ 215,113 10 Cost of Goods Sold For the three and nine months endedDecember 31, 2021 , the Company had cost of goods sold in the amount of$46,499 and$124,999 for online and wholesale customers. For the three and nine months endedDecember 31, 2020 was$34,348 and$133,391 as a result of sales of Tauri-GumTM to online customers and wholesale clients. For the purposes of cost of goods sold segmentation distributor cost of goods sold includes sales to customers that were distributors.
Cost of Goods Sold by sales channel for Tauri-GumTM for the three and nine
months ended
For the three months ended For the nine months ended December 31, December 31, 2021 2020 2021 2020 Cost of Goods Sold Distributor $ - $ - $ - $ - E-Commerce 44,175 34,348 96,865 106,648 Wholesale 2,324 - 28,134 26,743$ 46,499 $ 34,348 $ 124,999 $ 133,391 Operating Expenses
Marketing and advertising expense
For the three months endedDecember 31, 2021 , marketing and advertising expense from continuing operations was$134,713 compared to$105,899 for the same period in the prior year. The difference of$28,814 was primarily due to the billboard media campaign For the nine months endedDecember 31, 2021 , marketing and advertising expense from continuing operations was$541,449 compared to$180,801 for the same period in the prior year. The difference of$360,648 was primarily due to the conversion of inventory to samples at a cost of$123,826 , billboard media, social media campaigns, SEO consulting work, sales territory development and website maintenance during the nine months endedDecember 31, 2021 . Additionally, the Company did a direct mail campaign at a cost of$38,200 Research and development For the three months endedDecember 31, 2021 , research and development expense was$8,781 compared to$7,173 for the same period in the prior year. The current year increased expense was due to the work in the pharma clinical trial. For the nine months endedDecember 31, 2021 , research and development expense was$116,844 compared to$34,478 for the same period in the prior year. The current year increased expense was largely due to the Kosher certification of the Tauri-GumTM product line work in the pharma clinical trial totaling$47,464 as well as a$20,000 payment for a STUDY PROTOCOL DEVELOPMENT:TAURIGA SCIENCES NAUSEA IN PREGNANCY the nine months endedDecember 31, 2021 . Fulfillment services
For the three months ended
For the nine months endedDecember 31, 2021 , fulfillment services were$84,505 compared$64,200 for the same period in the prior year. The increase in current year expense was largely due to additional activity and increased e-commerce sales activity and product offering as well as the establishment of a new product warehouse inBrooklyn, NY .
General and Administrative Expense
For the three months ended
For the nine months endedDecember 31, 2021 and 2020, general and administrative expenses were$2,887,114 and$1,328,786 , respectively. This increase of$1,558,328 was primarily attributable to a larger consulting fee of$322,622 , increased legal fees of$73,742 , increased advisor, officer and director compensation of$232,516 , increased stock-based compensation of$717,536 , proxy expense of$28,627 and increased travel expense of$104,171 . 11
Depreciation and amortization
For the three and nine months endedDecember 31, 2021 , depreciation and amortization expense was$1,326 and$3,897 , respectively compared to$218 and$653 . Depreciation expense increase of$3,244 for the nine months endedDecember 31, 2021 was due to depreciation expense on new computer, presentation equipment and furniture for the new office. Additionally, the Company had amortization expense of$937 for sales display in the new corporate office for the nine months endedDecember 31, 2021 . Interest Expense
For the three months endedDecember 31, 2021 and 2020, interest expense was$67,129 and$289,503 , respectively. Interest expense decrease of$223,374 was due to the decreased expense for the issuance of commitment shares recorded as interest expense offset of lower recognition of debt discount.
For the nine months ended
Net Income (Loss) The Company generated net losses from continuing operations of$1,542,273 and$4,114,990 for the three and nine months endedDecember 31, 2021 , respectively compared to$22,169 and$1,614,449 for the same periods in the prior year. The increased net loss in the three months endedDecember 31, 2021 was primarily due to increase general and administrative costs of$790,399 , a lower unrealized gain of$932,627 and loss on trading securities of$142,884 . The increased net loss in the nine months endedDecember 31, 2021 in the amount of$2,500,541 was primarily due to increase general and administrative costs of$1,558,328 , increased marketing expense of$360,648 , unrealized loss on trading securities of$1,909,778 and a realized gain on trading securities of$1,233,525 in the prior year.
Liquidity and Capital Resources
OnDecember 31, 2021 , we had cash of$6,799 and 1,035,511 of securities compared toMarch 31, 2021 of$792,723 and$1,334,425 of trading securities. We have historically met our cash needs through a combination of proceeds from private placements of our securities, loans and convertible notes. Our cash requirements are generally for purchases of inventory as well as selling, general and administrative activities. We believe that our cash balance is not sufficient to finance our cash requirements for expected operational activities, capital improvements, and partial repayment of debt through the next 12 months.Net Cash provided by financing activities during the nine months endedDecember 31, 2021 and 2020 was$1,402,600 and$2,014,878 respectively. During the nine months endedDecember 31, 2021 , the Company received$1,196,500 proceeds from notes payable,$451,515 from the sale of common stock offset by the repayment of note principal of$245,000 . During 2020, the Company had proceeds from the sale of registered shares under the Tangiers Investment Agreement (equity line of credit, since terminated) in the amount of$400,515 , proceeds from the sale of common stock in the amount of$801,563 and$220,000 proceeds from notes payable offset by$100,000 for the repayment of note principal. As ofDecember 31, 2021 , current assets were exceeded by our current liabilities by$711,126 compared to current assets exceeding current liabilities by$1,229,211 atMarch 31,2021 . OnDecember 31, 2021 , current assets were$1,537,851 compared to$2,396,567 atMarch 31, 2021 . During fiscal year 2021, the Company's decrease in current assets was primarily due to a$541,702 decrease in the investment value of trading securities held by us. OnDecember 31, 2021 , current liabilities were$2,248,977 compared to$1,167,356 atMarch 31, 2021 . The Company's increase in current liabilities was mainly due to increased notes payable of$954,409 . Going Concern During the fourth quarter of the year endedMarch 31, 2019 , the Company began sales and marketing efforts for its Mint flavored Tauri-GumTM product. During the year endedMarch 31, 2021 , the Company recognized net sales of$285,319 and a gross profit of$122,692 . During the nine months endedDecember 31, 2021 , the Company recognized net sales of$243,293 and a gross profit of$118,294 . OnDecember 31, 2021 , the Company had a working capital deficit of$711,126 compared to$1,229,211 for the year endedMarch 31, 2021 . The current lower surplus is largely resultant from increased debt levels. Although the Company has a working capital surplus, there is no guarantee that this will continue therefore it still believes that there is uncertainty with respect to continuing as a going concern. 12 OnJuly 1, 2019 , months after theNYC Department of Heath announced a ban on cannabidiol in foods and beverages (mainly focused on restaurants and baked goods), the updated New York City Health Code was revised to include an embargoing of CBD-infused Edible(s) Products (including packaged products). The Company is hopeful that due to the recent regulatory regime for cannabinoid products implemented by the NYDPH, theNew York City Council will remove the current CBD ban and implement regulations surrounding CBD products in a logical and prompt manner. The Company believes it is well positioned under the current regulatory structure and has taken a conservative approach towards its products, including, for example, ensuring that its product manufacturer periodically tests for compliance with the Agricultural Improvement Act of 2018, such as utilizing CBD oils from hemp plants which contain 0.3% or less THC content. Subsequent to the balance sheet date, theState of New York has determined that it is allowable to sell CBD Infused Edible products in the forms of both food and drink (inclusive of chewing gum). It was also determined that at no time can CBD be sold in products that contain either alcohol or tobacco. Additionally, theState of New York also said that NO CBD product may be sold if it contains more than 0.3% (1/333rd by Composition) THC. No Individual food or beverage product may contain more than 25mg of Hemp-Extracted Cannabinoids ("CBD" or "CBG") per serving. Food and drink infused with CBD and Other Hemp Extracts must be packaged by the manufacturer and extracts cannot be added at the retail level. The Company's entire product line will comply with these standards. The Company, in the short term, intends to continue funding its operations either through cash-on-hand or through financing alternatives. Management's plans with respect to this include raising capital through equity markets to fund future operations as well as the possible sale of its remaining marketable securities which had a market value of $ equity markets to fund future operations as well as the possible sale of its remaining marketable securities which had a market value of$792,723 onDecember 31, 2021 . In the event the Company cannot raise additional capital to fund and/or expand operations or fails to raise adequate capital and generate adequate sales revenue, or if the regulatory landscape were to become more difficult or result in regulatory enforcement, it could result in the Company having to curtail or cease operations. Additionally, even if the Company does raise sufficient capital to support its operating expenses and generate adequate revenues in the short term, there can be no assurances that the revenues will be sufficient to enable it to develop business to a level where it will generate profits and cash flows from operations to achieve profitability thereby eliminating its reliance on alternative sources of funding. Although management believes that the Company continues to strengthen its financial position over time, there is still no guarantee that profitable operations with sufficient cashflow to sustain operations can or will be achieved without the need of alternative financing, which is limited. These matters still raise significant doubt about the Company's ability to continue as a going concern as determined by management. The Company believes that there is uncertainty with respect to continuing as a going concern until the operating business can achieve sufficient sales to maintain profitable operations and sustain cash flow to operate the Company for a period of twelve months. In the event the Company does need to raise additional capital to fund operations or engage in a transaction, failure to raise adequate capital and generate adequate sales revenues could result in the Company having to curtail or cease operations. Even if the Company does raise sufficient capital to support its operating expenses, acquire new license agreements or ownership interests in life science companies and generate adequate revenues, or the agreements entered into recently are successful, there can be no assurances that the revenues will be sufficient to enable it to develop business to a level where it will generate profits and cash flows from operations. These matters raise substantial doubt about the Company's ability to continue as a going concern as determined by management. However, the accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. These consolidated financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern. Contractual Obligations
Per Os Bio has contracted with the Company as the sole manufacturer of its Tauri-GumTM and are under contract to produce our product when ordered at approximately$6 per blister pack. Per OS is also required to have each batch independently tested to ensure that each piece of chewing gum must contain 10 milligrams ("mg") of CBD Isolate, has 0% THC Content and is clear for all microbiology. Due to the implementation of efficiencies and reduction in market price of the most important "basic factors of production costs" CBD and CBG Isolate, the cost per blister pack (as of 12/31/2020) has been reset to approximately$4 per blister pack. EffectiveJanuary 6, 2021 , the Company moved its corporate headquarters to4 Nancy Court , Suite 4,Wappingers Falls, New York 12590. The Company's telephone number remains the same, phone: 917-796-9926. The Company entered into a two-year lease, expiringJanuary 31, 2023 . We will pay$19,200 ($1,600 per month) during the first year of the term and$21,000 ($1,750 per month) during the second year of the term. The Company paid$1,600 as a refundable security deposit under the terms of our new headquarter lease.
Off-Balance Sheet Arrangements
As of
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