−Removed: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
−Removed: June 30, 2020, our common stock began trading on the Nasdaq Capital Market under the symbol “ADTX.”
−Removed: Prior to that
−Removed: time, there was no public market for our common stock.
−Removed: of March 24, 2021, there were approximately 135 record holders of our common stock and no holders of our preferred stock.
−Removed: The actual number of holders of our common stock is greater than this number of record holders, and includes stockholders who
−Removed: are beneficial owners, but whose shares are held in street name by brokers or held by other nominees.
−Removed: This number of holders of
−Removed: record also does not include stockholders whose shares may be held in trust by other entities.
−Removed: have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our
−Removed: common stock in the foreseeable future.
−Removed: We intend to retain all available funds and any future earnings to fund the development
−Removed: and expansion of our business.
−Removed: Any future determination to pay dividends will be at the discretion of our board of directors and
−Removed: will depend upon a number of factors, including our results of operations, financial condition, future prospects, contractual
−Removed: restrictions, restrictions imposed by applicable law and other factors that our board of directors deems relevant.
−Removed: Sales of Unregistered Securities
−Removed: November 6, 2020 the Company issued warrants to a consultant to purchase up to 120,000 shares of common stock at an exercise price
−Removed: of $1.92 per share for services rendered.
−Removed: December 31, 2020, the Company issued a consultant 650,000 shares of common stock upon completion of certain milestones included
−Removed: in a consulting agreement.
−Removed: Compensation Plans
−Removed: information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference
−Removed: to Item 12 of Part III of this Annual Report on Form 10-K.
−Removed: Purchases of Equity Securities
−Removed: did not purchase any of our registered equity securities during the period covered by this Annual Report.
−Removed: of Proceeds from Initial Public Offering
−Removed: July 2, 2020, we completed our initial public offering (“IPO”).
−Removed: In connection therewith, we issued 1,226,668 Units
−Removed: (the “Units”), excluding the underwriters’
−Removed: option to cover overallotments, at an offering price of $9.00 per
−Removed: Unit, resulting in gross proceeds of approximately $11.0 million.
−Removed: The Units issued in the IPO consisted of one share of common
−Removed: stock, one Series A warrant, and one Series B warrant.
−Removed: The Series A warrants originally had an exercise price of $9.00 and a term
−Removed: In addition, we issued a Unit Purchase Option at an exercise price of $11.25 per unit to the underwriters to purchase
−Removed: up to 67,466 units, with each unit consisting of (i) one share of common stock and (ii) one Series A Warrant.
−Removed: On August 19, 2020
−Removed: we modified the exercise price of the Series A Warrants from $9.00 per share to $4.50 per share.
−Removed: The term of the Series A Warrants
−Removed: was not modified.
−Removed: The Series B warrants have an exercise price of $11.25 per share, a term of 5 years and contain a cashless exercise
−Removed: option upon certain criteria being met.
−Removed: As of December 31, 2020, substantially all of the Series B warrants issued in the IPO have
−Removed: been exercised pursuant to a cashless provision therein.
−Removed: received net proceeds of $8.5 million in the IPO, after deducting underwriting discounts and commissions and issuance expenses
−Removed: No payments were made by us to directors, officers or persons owning ten percent or more of our common stock or to
−Removed: their associates, or to our affiliates, other than payments in the ordinary course of business to officers for salaries and to
−Removed: non-employee directors pursuant to our director compensation policy.
−Removed: Dawson James Securities, Inc.
−Removed: acted as lead book-running manager
−Removed: of the offering and as representative of the underwriters for the offering.
−Removed: has been no material change in the planned use of proceeds from our IPO from that described in the final prospectus related to
−Removed: the offering, dated June 29, 2020, as filed with the SEC.
−Removed: Selected Financial Data.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: following discussion and analysis of our financial condition and results of operations should be read together with our financial
−Removed: statements and the related notes and other financial information included elsewhere in this report.
−Removed: Some of the information contained
−Removed: in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy
−Removed: for our business, includes forward-looking statements that involve risks and uncertainties.
−Removed: See “Cautionary Note Regarding
−Removed: Forward-Looking Statements.”
−Removed: are a life sciences company with a mission of prolonging life and enhancing its quality by improving the health of the immune
−Removed: Our immune reprogramming technology is currently at the pre-clinical stage and designed to retrain the immune system to
−Removed: induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies.
−Removed: monitoring technology is designed to provide a personalized comprehensive profile of the immune system and we plan to utilize
−Removed: it in our upcoming clinical trials to monitor subjects’
−Removed: immune response before, during and after drug administration.
−Removed: are also evaluating plans to obtain FDA approval for this monitoring tool’s use as a clinical assay.
−Removed: On January 25, 2021 (the “Closing Date”), we entered into a Securities Purchase Agreement (the “Purchase
−Removed: Agreement”) with an institutional accredited investor for the offering, sale, and issuance (the “Offering”)
−Removed: of a $6,000,000 Senior Secured Convertible Promissory Note (the “Note”).
−Removed: Concurrently with the sale of the Note, pursuant
−Removed: to the Purchase Agreement, we also issued a warrant “January 2021 Warrant”) to the investor to purchase up to 800,000
−Removed: shares (the “January 2021 Warrant Shares”) of the Company’s common stock.
−Removed: As a result of the Offering, the Company
−Removed: received aggregate gross proceeds of $5,000,000.
−Removed: Note has a twenty-four month term and is convertible at the option of the investor at any time prior to maturity in shares of
−Removed: Common Stock (the “Conversion Shares”) at an initial conversion price of $4.00 per share, subject to adjustment under
−Removed: certain circumstances.
−Removed: The Note amortizes in nineteen (19) equal monthly installments (the “Installment Payments”)
−Removed: starting the first day of the sixth month after the Closing Date (each, an “Installment Date”).
−Removed: At the Company’s
−Removed: option, Installment Payments may be made in cash or in shares of the Company’s common stock.
−Removed: If the Company elects to repay
−Removed: in cash, the amount payable shall be 105% of the applicable Installment Payment.
−Removed: If the Company elects to repay in shares of common
−Removed: stock, the shares shall be priced at the lowest of (i) the Conversion Price then in effect, and (ii) the greater of (x) the Floor
−Removed: Price (as defined in the Note) and (y) the lower of 90% of the lowest volume weighted average price (VWAP) of the common stock
−Removed: for each of the five (5) Trading Days (as such term is defined in the Note) ending and including the Trading Day immediately prior
−Removed: to the applicable Installment Date.
−Removed: Installment Payments are subject to the investor’s right to (a) defer some or all of any Installment Payment to a subsequent
−Removed: Installment Date or (b) to convert an additional Installment Payment of the Note at the then-current Installment Price until the
−Removed: next Installment Date.
−Removed: Upon the occurrence of an Event of Default or a Change of Control (as such terms are defined in the Note),
−Removed: the Note is subject to redemption by the investor.
−Removed: The Company is prohibited from effecting a conversion of the Note to the extent
−Removed: that, as a result of such exercise, the investor, together with the its affiliates, would beneficially own more than 4.99% of
−Removed: the number of shares of common stock of the Company outstanding immediately after giving effect to the issuance of the such shares,
−Removed: which beneficial ownership limitation may be increased by the investor up to, but not exceeding, 9.99%.
−Removed: January 2021 Warrants are immediately exercisable for a period of three (3) years at an exercise price of $4.00 per share, subject
−Removed: to adjustment.
−Removed: After a period of one hundred eight (180) days, if a registration statement covering the resale of the shares of
−Removed: common stock underlying the January 2021 Warrants is not effective, the holder may exercise the January 2021 Warrant by means
−Removed: of a cashless exercise.
−Removed: The Company is prohibited from effecting an exercise of the January 2021 Warrants to the extent that,
−Removed: as a result of such exercise, the holder of the January 2021 Warrants together with the holder’s affiliates, would beneficially
−Removed: own more than 4.99% of the number of shares of common stock of the Company outstanding immediately after giving effect to the
−Removed: issuance of the such shares, which beneficial ownership limitation may be increased by the holder up to, but not exceeding, 9.99%.
−Removed: Additionally,
−Removed: until the earlier of the (i) one year anniversary the Closing Date, and (ii) such time as less than $2 million of aggregate Principal
−Removed: Amount (as such term is defined in the Note) of the Note remains outstanding, the Company is prohibited from effecting or entering
−Removed: into an agreement to effect any issuance of securities involving a Variable Rate Transaction (as such term is defined in the Purchase
−Removed: Reprogramming
−Removed: discovery of immunosuppressive (anti-rejection and monoclonal) drugs over 40 years ago has made possible life-saving organ transplantation
−Removed: procedures and blocking of unwanted immune responses in autoimmune diseases.
−Removed: However, immune suppression leads to significant
−Removed: undesirable side effects, such as increased susceptibility to life-threatening infections and cancers, because it indiscriminately
−Removed: and broadly suppresses immune function throughout the body.
−Removed: While the use of these drugs has been justifiable because they prevent
−Removed: or delay organ rejection, their use for treatment of autoimmune diseases and allergies may not be acceptable because of the aforementioned
−Removed: side effects.
−Removed: Furthermore, transplanted organs often ultimately fail despite the use of immune suppression, and about 40% of transplanted
−Removed: organs survive no more than 5 years.
−Removed: focused therapeutic approaches are needed that modulate only the small portion of immune cells that are involved in rejection
−Removed: of the transplanted organ, as this approach can be safer for patients than indiscriminate immune suppression.
−Removed: Such approaches
−Removed: are referred to as immune tolerance, and when therapeutically induced, may be safer for patients and also potentially allow long-term
−Removed: survival of transplanted tissues and organs.
−Removed: the late 1990s, academic research on these approaches was conducted at the Transplant Center in Loma Linda University (“LLU”)
−Removed: in connection with a project that secured initial grant funding from the U.S.
−Removed: Department of Defense.
−Removed: The focus of that project
−Removed: was for skin grafting for burn victims.
−Removed: Twenty years of research at LLU and an affiliated incubator led to a series of discoveries
−Removed: that have been translated into a large patent portfolio of therapeutic approaches that may be applied to the modulation of the
−Removed: immune system in order to induce tolerance to self and transplanted organs.
−Removed: have an exclusive worldwide license for commercializing this nucleic acid-based technology (which is currently at the pre-clinical
−Removed: stage), named Apoptotic DNA Immunotherapy™
−Removed: (ADi™) from LLU, which utilizes a novel approach that mimics the way the
−Removed: body naturally induces tolerance to our own tissues (“therapeutically induced immune tolerance”).
−Removed: While immune suppression
−Removed: requires continuous administration to prevent rejection of a transplanted organ, induction of tolerance has the potential to retrain
−Removed: the immune system to accept the organ for longer periods of time.
−Removed: Thus, ADi™
−Removed: may allow patients to live with transplanted
−Removed: organs with significantly reduced immune suppression.
−Removed: is a technology platform which we believe can be engineered to
−Removed: address a wide variety of indications.
−Removed: are developing ADi™
−Removed: products for organ transplantation including skin grafting, autoimmune diseases, and allergies, with
−Removed: the initial focus on skin allografts and psoriasis, as we believe these indications will be most efficient in providing safety
−Removed: and efficacy data in clinical trials.
−Removed: To submit a Biologics License Application (“BLA”) for a biopharmaceutical product,
−Removed: clinical safety and efficacy must be demonstrated in a series of clinical studies conducted with human subjects.
−Removed: in our class of drugs, the first-in-human trials will be a combination of Phase I (safety/tolerability) and Phase II (efficacy)
−Removed: in affected subjects.
−Removed: To obtain approval to initiate the Phase I/IIa studies, an Investigational New Drug Application will be
−Removed: submitted to compile non-clinical efficacy data as well as manufacturing and pre-clinical safety/toxicology data.
−Removed: have conducted non-clinical studies in a stringent model of skin transplantation using genetically mismatched donor and recipient
−Removed: animals demonstrating a 3-fold increase in the survival of the skin graft in animals that were tolerized with ADi™
−Removed: to animals that receive immune suppression alone.
−Removed: Prolongation of graft life was observed despite discontinuation of immune suppression
−Removed: after the first 5 weeks.
−Removed: Additionally, in an induced non-clinical model for psoriasis, ADi™
−Removed: treatment resulted in a 69%
−Removed: reduction in skin thickness and a 38% decrease in skin flaking (two clinical parameters for assessment of psoriasis skin lesions).
−Removed: The Phase I/IIa studies in psoriasis will evaluate the safety/tolerability of ADi™
−Removed: in patients diagnosed with psoriasis.
−Removed: Since the drug will be administered in subjects diagnosed with psoriasis, effectiveness of the drug to improve psoriatic lesions
−Removed: will also be evaluated.
−Removed: In another Phase I/IIa study, patients requiring skin allografts will receive weekly intra-dermal injections
−Removed: of ADi™
−Removed: in combination with standard immune suppression to assess safety/tolerability and possibility of reducing levels
−Removed: of immunosuppressive drugs as well as prolongation of graft life.
−Removed: Later phase trials are planned after successful completion of
−Removed: these studies in preparation for submission for a BLA to regulatory agencies.
−Removed: believe that understanding the status of an individual’s immune system is key to developing and administering immunotherapies
−Removed: such as ADi™.
−Removed: We have secured an exclusive worldwide license for commercializing a technology platform named AditxtScore™,
−Removed: which provides a personalized comprehensive profile of the immune system.
−Removed: It is intended to be informative for individual immune
−Removed: responses to viruses, bacterial antigens, peptides, drugs, bone marrow and solid organ transplants, and cancer.
−Removed: It has broad applicability
−Removed: to many other agents of clinical interest impacting the immune system, including those not yet identified such as future infectious
−Removed: AditxtScore™
−Removed: is being designed to allow individuals to understand, manage and monitor their immune profiles in order to be informed about attacks
−Removed: on or by their immune system.
−Removed: We believe AditxtScore™
−Removed: can also assist the medical community in anticipating possible immune
−Removed: responses and reactions to viruses, bacteria, allergens and transplanted organs.
−Removed: It can be useful in anticipating attacks on the
−Removed: body by having the ability to determine its potential response and for developing a plan to deal with an undesirable reaction
−Removed: by the immune system.
−Removed: Its advantages include the ability to provide a simple, rapid, accurate, high throughput, single platform
−Removed: assay that can be multiplexed to determine the immune status with respect to several factors simultaneously, in 3-16 hours, as
−Removed: well as detect antigen and antibody in a single test (i.e.
−Removed: infectious, recovered, immune).
−Removed: In addition, it can determine and differentiate
−Removed: between various types of cellular and humoral immune responses (T and B cells).
−Removed: It also provides for simultaneous monitoring of
−Removed: cell activation and levels of cytokine release (i.e., cytokine storms).
−Removed: plan to utilize AditxtScore™
−Removed: in our upcoming clinical trials to monitor subjects’
−Removed: immune response before, during and
−Removed: after ADi™
−Removed: drug administration.
−Removed: We are also evaluating plans to obtain FDA approval for AditxtScore™’s use as
−Removed: a clinical assay and seeking to secure manufacturing, marketing and distribution partnerships for application in the Infectious
−Removed: Diseases market, by end of 2020.
−Removed: To obtain FDA approval to use AditxtScore™
−Removed: as a clinical assay, we plan to conduct validation
−Removed: studies comparing AditxtScore™
−Removed: to other immunological tests to demonstrate reproducibility of data and to demonstrate the
−Removed: sensitivity of the assays for use in different indications (e.g., detection of antigens present in infectious agents or antibodies
−Removed: against infectious agents).
−Removed: We believe that these data will show AditxtScore™’s ability to multiplex in two ways using
−Removed: a single assay:
−Removed: (i) evaluating the immune response to multiple antigens (from different infectious agents) and (ii) measuring
−Removed: quantities of multiple cytokines.
−Removed: Furthermore, we believe that the additional validation studies will demonstrate AditxtScore™’s
−Removed: ability to measure the presence of several antibody isotypes against several antigens in a single reaction.
−Removed: Our plan is to submit
−Removed: a 510(K) application to the FDA after successful completion of these studies.
−Removed: We have engaged consultants for our communications
−Removed: and submissions to the FDA.
−Removed: Beyond 2020, we plan to develop AditxtScore™for applications in additional markets such as Organ
−Removed: Rejection, Allergies, Drug/Vaccine Response, and Disease Susceptibility.
−Removed: The initial application
−Removed: of the platform will be AditxtScore™
−Removed: for COVID-19 which has been designed to provide a more complete assessment of an individual’s
−Removed: infection and immunity status with respect to the SARS-CoV-2 virus.
−Removed: Infection status will be determined by evaluating the presence
−Removed: or absence of the virus, and immunity status by measuring levels of antibodies against viral antigens and their ability to neutralize
−Removed: We will soon be expanding the panel to measure other components of the immune response such as cellular immunity.
−Removed: early 2021, we established our AditxtScore™
−Removed: Immune Monitoring Center in Richmond, Virginia (the “Center”).
−Removed: Center operates as a Clinical Laboratory Improvement Amendments (CLIA) certified facility for the processing of our AditxtScore™
−Removed: for COVID-19 Lab Developed Test (LDT) for our prospective channel partners, including labs and hospitals.
−Removed: Agreement with Loma Linda University
−Removed: March 8, 2018, we entered into an Assignment Agreement (the “Assignment Agreement”) with Sekris Biomedical, Inc.
−Removed: (“Sekris”).
−Removed: Sekris was a party to a License Agreement with Loma Linda University (“LLU”), entered into and made effective on May
−Removed: 25, 2011, and amended on June 24, 2011, July 16, 2012 and December 27, 2012 (the “Original Agreement,”
−Removed: with the Assignment Agreement, the “Sekris Agreements”).
−Removed: Pursuant to the Assignment Agreement, Sekris transferred
−Removed: and assigned all of its rights and obligations in and to the liabilities under the Original Agreement, of whatever kind or nature,
−Removed: In exchange, on March 8, 2018, we issued a warrant to Sekris to purchase up to 500,000 shares of our common stock (the
−Removed: “Sekris Warrant”).
−Removed: The warrant was immediately exercisable and has an exercise price of $4.00 per share.
−Removed: The expiration
−Removed: date of the warrant is March 8, 2023.
−Removed: On March 15, 2018, as amended on July 1, 2020, we entered into a LLU License Agreement directly
−Removed: with Loma Linda University, which amends and restates the Sekris Agreements.
−Removed: to the LLU License Agreement, we obtained the exclusive royalty-bearing worldwide license in and to all intellectual property,
−Removed: including patents, technical information, trade secrets, proprietary rights, technology, know-how, data, formulas, drawings, and
−Removed: specifications, owned or controlled by LLU and/or any of its affiliates (the “LLU Patent and Technology Rights”) and
−Removed: related to therapy for immune-mediated inflammatory diseases (the ADi™
−Removed: In consideration for the LLU License
−Removed: Agreement, we issued 25,000 shares of common stock to LLU.
−Removed: to the LLU License Agreement, we are required to pay an annual license fee to LLU.
−Removed: Also, we paid LLU $455,000 in July
−Removed: 2020 in payment of outstanding milestone payments and license fees.
−Removed: We are also required to pay to LLU milestone payments in connection
−Removed: with certain development milestones.
−Removed: Specifically, we are required to make the following milestone payments:
−Removed: $175,000 on March
−Removed: $100,000 on March 31, 2024;
−Removed: $500,000 on March 31, 2026;
−Removed: and $500,000 on March 31, 2027.
−Removed: Additionally, as consideration
−Removed: for prior expenses incurred by LLU to prosecute, maintain and defend the LLU Patent and Technology Rights, we were obligated to
−Removed: make the following payments to LLU:, $70,000 was paid at the end of December 2018, and a final payment of $60,000 due at
−Removed: the end of March 2019.
−Removed: We are required to defend the LLU Patent and Technology Rights during the term of the LLU License Agreement.
−Removed: Additionally, we will owe royalty payments of (i) 1.5% of Net Product Sales and Net Service Sales on any Licensed Products (defined
−Removed: as any finished pharmaceutical products which utilizes the LLU Patent and Technology Rights in its development, manufacture or
−Removed: supply), and (ii) 0.75% of Net Product Sales and Net Service Sales for Licensed Products and Licensed Services not covered by
−Removed: a valid patent claim for technology rights and know-how for a three (3) year period beyond the expiration of all valid patent
−Removed: We also are required to produce a written progress report to LLU, discussing our development and commercialization efforts,
−Removed: within 45 days following the end of each year.
−Removed: All intellectual property rights in and to LLU Patent and Technology Rights shall
−Removed: remain with LLU (other than improvements developed by or on our behalf).
−Removed: LLU License Agreement shall terminate on the last day that a patent granted to us by LLU is valid and enforceable or the day
−Removed: that the last patent application licensed to us is abandoned.
−Removed: The LLU License Agreement may be terminated by mutual agreement
−Removed: or by us upon 90 days written notice to LLU.
−Removed: LLU may terminate the LLU License Agreement in the event of (i) non-payments or late
−Removed: payments of royalty, milestone and license maintenance fees not cured within 90 days after delivery of written notice by LLU,
−Removed: (ii) a breach of any non-payment provision (including the provision that requires us to meet certain deadlines for milestone events
−Removed: (each, a “Milestone Deadline”)) not cured within 90 days after delivery of written notice by LLU and (iii) LLU delivers
−Removed: notice to us of three or more actual breaches of the LLU License Agreement by us in any 12-month period.
−Removed: Additional Milestone
−Removed: Deadlines include:
−Removed: (i) the requirement to have regulatory approval of an IND application to initiate a first-in-human clinical
−Removed: trials on or before March 31, 2022, (ii) the completion of first-in-human (phase I/II) clinical trials by March 31, 2024, (iii)
−Removed: the completion of Phase III clinical trials by March 31, 2026 and (iv) biologic licensing approval by the FDA by March 31, 2027.
−Removed: Agreement with Leland Stanford Junior University (“Stanford”)
−Removed: February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford
−Removed: with regard to a patent concerning a method for detection and measurement of specific cellular responses.
−Removed: Pursuant to the February
−Removed: 2020 License Agreement, we received an exclusive worldwide license to Stanford’s patent with regard to use, import, offer,
−Removed: and sale of Licensed Products (as defined in the agreement).
−Removed: The license to the patented technology is exclusive, including the
−Removed: right to sublicense, beginning on the effective date of the agreement and ending when the patent expires.
−Removed: Under the exclusivity
−Removed: agreement, we acknowledged that Stanford had already granted a non-exclusive license in the Nonexclusive Field of Use, under the
−Removed: Licensed Patents in the Licensed Field of Use in the Licensed Territory (as those terms are defined in the February 2020 License
−Removed: Agreement”).
−Removed: However, Stanford agreed to not grant further licenses under the Licensed Patents in the Licensed Field of
−Removed: Use in the Licensed Territory.
−Removed: were obligated to pay and paid a fee of $25,000 to Stanford within 60 days of February 3, 2020.
−Removed: We also issued 18,750 shares of the Company’s
−Removed: common stock to Stanford.
−Removed: An annual licensing maintenance fee is payable by us on the first anniversary of the February 2020 License
−Removed: Agreement in the amount of $40,000 for 2021 through 2024 and $60,000 starting in 2025 until the license expires upon the expiration of
−Removed: The Company is required to pay and has paid $25,000 for the issuances of certain patents.
−Removed: The Company will pay milestone
−Removed: fees of $50,000 on the first commercial sales of a licensed product and $25,000 at the beginning of any clinical study for regulatory
−Removed: clearance of an in vitro diagnostic product developed and a potential licensed product.
−Removed: We are also required to:
−Removed: provide a listing of the management team or a schedule for the recruitment of key management positions by March 31, 2020 (which has been
−Removed: completed), (ii) provide a business plan covering projected product development, markets and sales forecasts, manufacturing and operations,
−Removed: and financial forecasts until at least $10,000,000 in revenue by June 30, 2020 (which has been completed), (iii) conduct validation studies
−Removed: by September 30, 2020 (which has been completed), (iv) hold a pre-submission meeting with the FDA by September 30, 2020 (which has been
−Removed: completed), (v) submit a 510(k) application to the FDA, Emergency Use Authorization (“EUA”), or a Laboratory Developed Test
−Removed: (“LDT”) by March 31, 2021, (vi) obtain FDA approval by December 31, 2021, (vii) complete a prototype assay kit by December
−Removed: 31, 2021 and (viii) have a written agreement with Stanford on further development and commercialization milestones for specific fields
−Removed: of use by December 31, 2021.
−Removed: addition to the annual license maintenance fees outlined above, we will pay Stanford royalties on Net Sales (as such term is defined
−Removed: in the February 2020 License Agreement) during the of the term of the agreement as follows:
−Removed: 4% when Net Sales are below or equal
−Removed: to $5 million annually or 6% when Net Sales are above $5 million annually.
−Removed: The February 2020 License Agreement may be terminated
−Removed: upon our election on at least 30 days advance notice to Stanford, or by Stanford if we:
−Removed: (i) are delinquent on any report or payment;
−Removed: (ii) are not diligently developing and commercializing Licensed Product;
−Removed: (iii) miss certain performance milestones;
−Removed: breach of any provision of the February 2020 License Agreement;
−Removed: or (v) provide any false report to Stanford.
−Removed: Should any events
−Removed: in the preceding sentence occur, we have a thirty (30) day cure period to remedy such violation.
−Removed: have assembled a team of experts from a variety of scientific fields and commercial backgrounds, with many years of collective
−Removed: experience that ranges from founding startup biotech companies, to developing and marketing biopharmaceutical products, to designing
−Removed: clinical trials, and to management of private and public companies.
−Removed: We were incorporated on September 28, 2017 and has not generated
−Removed: revenues to date.
−Removed: During the year ended December 31, 2020 we had a net loss of $9,149,227 and will require significant additional
−Removed: capital in order to operate in the normal course of business and fund clinical studies in the long-term.
−Removed: As a result of the IPO
−Removed: and the September 2020 Offering, we received net proceeds of approximately $18 million during the period.
−Removed: We believe that the funds
−Removed: raised by the IPO and the September 2020 Offering will be sufficient to fund our operations for at least the next 12 months.
−Removed: a result, these conditions have alleviated the doubt regarding our ability to continue as a going concern beyond one year.
−Removed: have a limited operating history.
−Removed: Therefore, there is limited historical financial information upon which to base an evaluation
−Removed: of our performance.
−Removed: Our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently
−Removed: encountered by companies in their early stages of operations.
−Removed: Our financial statements as of December 31, 2020, show a net loss
−Removed: of $9,149,227.
−Removed: We expect to incur additional net expenses over the next several years as we continue to maintain and expand our
−Removed: existing operations.
−Removed: The amount of future losses and when, if ever, we will achieve profitability are uncertain.
−Removed: July 2, 2020, we completed an IPO.
−Removed: In connection therewith, we issued 1,226,668 Units, excluding the underwriters’
−Removed: overallotment,
−Removed: at an offering price of $9.00 per Unit, resulting in gross proceeds of approximately $11.0 million.
−Removed: The Units issued in the IPO
−Removed: consisted of one share of common stock, one Series A warrant, and one Series B warrant.
−Removed: The Series A warrants originally had an
−Removed: exercise price of $9.00 and a term of 5 years.
−Removed: In addition, the Company issued a Unit Purchase Option at an exercise price of
−Removed: $11.25 per unit to the underwriters to purchase up to 67,466 units, with each unit consisting of (i) one share of common stock
−Removed: and (ii) one Series A Warrant.
−Removed: On August 19, 2020 the Company modified the exercise price of the Series A Warrants from $9.00
−Removed: per share to $4.50 per share.
+Added: Market for Registrant’s Common
+Added: Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
+Added: Market Information
+Added: On June 30, 2020, our common
+Added: stock began trading on the Nasdaq Capital Market under the symbol “ADTX.” Prior to that time, there was no public market for
+Added: our common stock.
+Added: As of March 29, 2022, there
+Added: were approximately 136 record holders of our common stock and no holders of our preferred stock.
+Added: The actual number of holders of
+Added: our common stock is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares
+Added: are held in street name by brokers or held by other nominees.
+Added: This number of holders of record also does not include stockholders whose
+Added: shares may be held in trust by other entities.
+Added: Dividend Policy
+Added: We have never paid or declared
+Added: any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
+Added: We intend to retain all available funds and any future earnings to fund the development and expansion of our business.
+Added: Any future determination
+Added: to pay dividends will be at the discretion of our board of directors and will depend upon a number of factors, including our results of
+Added: operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors
+Added: that our board of directors deems relevant.
+Added: Recent Sales of Unregistered Securities
+Added: On November 1, 2021 the Company issued 3,000 shares
+Added: of common stock for services rendered.
+Added: On November 16, 2021 the Company issued 3,600
+Added: shares of common stock for services rendered.
+Added: On November 30, 2021 the Company issued 3,000
+Added: shares of common stock for services rendered.
+Added: On December 9, 2021 the Company issued 57,397
+Added: shares of common stock for services rendered.
+Added: On December 9, 2021 the Company issued 11,348
+Added: shares of common stock for services rendered.
+Added: On December 9, 2021 the Company issued 11,348
+Added: shares of common stock for services rendered.
+Added: On December 30, 2021 the Company issued 3,000
+Added: shares of common stock for services rendered.
+Added: The foregoing issuances were exempt from registration
+Added: under Section 4(a)(2) of the Securities Act.
+Added: Equity Compensation Plans
+Added: The information required by
+Added: Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part III
+Added: of this Annual Report on Form 10-K.
+Added: Issuer Purchases of Equity Securities
+Added: We did not purchase any of
+Added: our registered equity securities during the period covered by this Annual Report.
+Added: Use of Proceeds from Initial Public Offering
+Added: On July 2, 2020, we completed
+Added: our initial public offering (“IPO”).
+Added: In connection therewith, we issued 1,226,668 Units (the “IPO Units”), excluding
+Added: the underwriters’ option to cover overallotments, at an offering price of $9.00 per IPO Unit, resulting in gross proceeds of approximately
+Added: $11.0 million.
+Added: The IPO Units issued in the IPO consisted of one share of common stock, one Series A warrant, and one Series B warrant.
+Added: The Series A warrants originally had an exercise price of $9.00 and a term of 5 years.
+Added: In addition, we issued a Unit Purchase Option at
+Added: an exercise price of $11.25 per unit to the underwriters to purchase up to 67,466 units, with each unit consisting of (i) one share of
+Added: common stock and (ii) one Series A Warrant.
+Added: On August 19, 2020 we modified the exercise price of the Series A Warrants from $9.00 per
+Added: share to $4.50 per share.
The term of the Series A Warrants was not modified.
−Removed: The Series B warrants have an exercise price
−Removed: of $11.25 per share and a term of 5 years.
−Removed: Substantially all of the Series B warrants issued in the IPO as part of the Units have
−Removed: been exercised pursuant to a cashless provision therein.
−Removed: September 10, 2020, we completed a follow-on public offering (“September 2020 Offering”).
−Removed: In connection therewith,
−Removed: we issued 2,400,000 units, or Follow-On Units, excluding the underwriters’
−Removed: option to cover overallotments, at an offering
−Removed: price of $4.00 per Follow-On Unit, resulting in gross proceeds to the Company of approximately $9.6 million.
−Removed: Each of the Follow-On
−Removed: Units issued in the September 2020 Offering consisted of one share of common stock or Series A Preferred Stock for investors who
−Removed: would own more than 4.99% of the Company if they invested in common stock, one Series A-1 warrant, and one Series B-1 warrant.
−Removed: The Series A-1 warrants have an exercise price of $3.19 per share and a term of 5 years.
−Removed: The Series B-1 warrants have exercise
−Removed: price of $5.00 per share, a term of 5 years and contain a cashless exercise option upon certain criteria being met.
−Removed: the Company issued a warrant to the underwriters to purchase up to 60,000 shares of common stock at an exercise price of $5.00
−Removed: Subsequent to quarter end, substantially all of the Series B-1 warrants issued in the September 2020 Offering have
−Removed: been exercised pursuant to a cashless provision therein.
−Removed: of Operations
−Removed: of operations for the year ended December 31, 2020
−Removed: the year ended December 31, 2020, we incurred a loss from operations of $8,872,209.
−Removed: This is due to general and administrative
−Removed: expenses of $7,852,256, which includes $3,188,840 in stock-based compensation, research and development of $937,966, and sales
−Removed: and marketing expenses of $81,987.
−Removed: The $937,966 in research and development is comprised of $258,635 in licensing fees, $519,171
−Removed: in product development, and $160,160 in other research and development expense.
−Removed: the year ended December 31, 2019, we incurred a loss from operations of $5,870,798.
−Removed: This is due to general and administrative
−Removed: expenses of $5,694,806, which includes $4,221,733 in stock-based compensation, research and development of $175,441, which includes
−Removed: $10,000 in stock-based compensation, and sales and marketing expenses of $551.
−Removed: The $175,441 in research and development is comprised
−Removed: of $18,396 in licensing fees, $54,000 in product development and $103,045 in other research and development expense.
−Removed: increase in expenses during the year ended December 31, 2020 compared to the year ended December 31, 2019 was due to the Company
−Removed: beginning to execute its business plan and incur costs of being a public company.
−Removed: and Capital Resources
−Removed: We have incurred substantial operating losses since inception and
−Removed: expect to continue to incur significant operating losses for the foreseeable future and may never become profitable.
−Removed: As of December
−Removed: 31, 2020, we had an accumulated deficit of $20,879,178.
−Removed: We had working capital of $9,806,195 as of December 31, 2020.
−Removed: year ended December 31, 2020, we paid off outstanding notes payable with a principal totaling $715,600 and accrued interest totaling
−Removed: During the year ended December 31, 2020, we paid $170,629 for the purchase of fixed assets and $58,475 on payments for
−Removed: financed assets.
−Removed: These fixed assets were purchased to furnish our new office and laboratory.
−Removed: Approximately $105,000 of these purchased
−Removed: fixed assets were lab equipment, approximately $55,000 was for office furniture and equipment, approximately $10,000 was for computers,
−Removed: and approximately $1,000 was for other fixed assets.
−Removed: financial statements have been prepared assuming that we will continue as a going concern.
−Removed: have funded our operations from proceeds from the sale of equity and debt securities.
−Removed: On July 2, 2020, we completed our IPO and
−Removed: raised approximately $9.5 million in net proceeds.
−Removed: At the time of the IPO, we believed that these funds would be sufficient to
−Removed: fund our operations for the foreseeable future.
−Removed: September 10, 2020, we completed a follow-on public offering.
−Removed: In connection therewith, we issued 2,400,000 units, or Follow-On
−Removed: Units, excluding the underwriters’
−Removed: option to cover overallotments, at an offering price of $4.00 per Follow-On Unit, resulting
−Removed: in gross proceeds of approximately $9.6 million.
−Removed: may need to raise significant additional capital to continue to fund our operations and the clinical trials for our product candidates.
−Removed: We may seek to sell common stock, preferred stock or convertible debt securities, enter into a credit facility or another form
−Removed: of third-party funding or seek other debt financing.
−Removed: In addition, we may seek to raise cash through collaborative agreements or
−Removed: from government grants.
−Removed: The sale of equity and convertible debt securities may result in dilution to our stockholders and certain
−Removed: of those securities may have rights senior to those of our common shares.
−Removed: If we raise additional funds through the issuance of
−Removed: preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that
−Removed: would restrict our operations.
−Removed: Any other third-party funding arrangement could require us to relinquish valuable rights.
−Removed: source, timing and availability of any future financing will depend principally upon market conditions, and, more
−Removed: specifically, on the progress of our clinical development program.
−Removed: Funding may not be available when needed, at all, or on
−Removed: terms acceptable to us.
−Removed: Lack of necessary funds may require us to, among other things, delay, scale back or eliminate
−Removed: expenses including some or all of our planned development, including our clinical trials.
−Removed: While we may need to raise funds in
−Removed: the future, we believe the current cash reserves should be sufficient to fund our operation for the foreseeable future.
−Removed: Because of these factors, we believe that this alleviates the issues about our ability to continue as a going
−Removed: following table shows our contractual obligations as of December 31, 2020:
−Removed: Payment Due by Year
−Removed: Financed asset
−Removed: Total contractual obligations
−Removed: Accounting Polices and Estimates
−Removed: financial statements are prepared in accordance with generally accepted accounting principles in the United States.
−Removed: The preparation
−Removed: of our financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported
−Removed: amount of assets, liabilities, revenue, costs and expenses, and related disclosures.
−Removed: We believe that of our critical accounting
−Removed: policies described under the heading “Management’s Discussion and Analysis of Financial Condition and Plan of Operations—Critical
−Removed: Accounting Policies”
−Removed: in our Prospectus, dated September 1, 2020, filed with the SEC pursuant to Rule 424(b), are critical
−Removed: to fully understanding and evaluating our financial condition and results of operations.
−Removed: The following involve the most judgment
−Removed: and complexity:
−Removed: and development
−Removed: compensation expense
−Removed: value of common stock
−Removed: we believe the policies set forth above are critical to fully understanding and evaluating our financial condition and results
−Removed: of operations.
−Removed: If actual results or events differ materially from the estimates, judgments and assumptions used by us in applying
−Removed: these policies, our reported financial condition and results of operations could be materially affected.
−Removed: Sheet Arrangements
−Removed: did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the
−Removed: rules and regulations of the SEC.
−Removed: April 5, 2012, the JOBS Act was enacted.
−Removed: Section 107 of the JOBS Act provides that an “emerging growth company”
−Removed: can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying
−Removed: with new or revised accounting standards.
−Removed: In other words, an “emerging growth company”
−Removed: can delay the adoption of certain
−Removed: accounting standards until those standards would otherwise apply to private companies.
−Removed: have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for
−Removed: complying with new or revised accounting standards until those standards would otherwise apply to private companies provided under
−Removed: the JOBS Act.
−Removed: are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the
−Removed: Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,”
−Removed: to rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report
−Removed: on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and
−Removed: (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board (“PCAOB”)
−Removed: regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the
−Removed: audit and the financial statements, known as the auditor discussion and analysis.
−Removed: We will remain an “emerging growth company”
−Removed: until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion
−Removed: (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering;
−Removed: (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years;
−Removed: or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission.
−Removed: Issued and Adopted Accounting Pronouncements
−Removed: Note 3 - Summary of Significant Accounting Policies to the accompanying financial statements for a description of other accounting
−Removed: policies and recently issued accounting pronouncements.
−Removed: Quantitative and Qualitative Disclosures About Market Risk.
−Removed: are not required to provide the information required by this Item as it is a “smaller reporting company,”
−Removed: in Rule 229.10(f)(1).
−Removed: Financial Statements and Supplementary Data.
−Removed: pages F-1 through F-17 following the Exhibit Index of this Annual Report on Form 10-K.
−Removed: Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
+Added: The Series B warrants have an exercise price of $11.25 per
+Added: share, a term of 5 years and contain a cashless exercise option upon certain criteria being met.
+Added: As of December 31, 2020, substantially
+Added: all of the Series B warrants issued in the IPO have been exercised pursuant to a cashless provision therein.
+Added: We received net proceeds of
+Added: $8.5 million in the IPO, after deducting underwriting discounts and commissions and issuance expenses borne by us.
+Added: No payments were made
+Added: by us to directors, officers or persons owning ten percent or more of our common stock or to their associates, or to our affiliates, other
+Added: than payments in the ordinary course of business to officers for salaries and to non-employee directors pursuant to our director compensation
+Added: Dawson James Securities, Inc.
+Added: acted as lead book-running manager of the offering and as representative of the underwriters for
+Added: the offering.
+Added: There has been no material
+Added: change in the planned use of proceeds from our IPO from that described in the final prospectus related to the offering, dated June 29,
+Added: 2020, as filed with the SEC.
+Added: Not applicable.
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.