−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations
−Removed: following discussion of our financial condition and results of operations should be read in conjunction with the financial statements
−Removed: and notes included in Part I “Financial Information”, Item I “Financial Statements” of this Quarterly Report
−Removed: on Form 10-Q (the “Report”) and the audited financial statements and related footnotes included in our Annual Report on Form
−Removed: 10-K for the year ended September 30, 2020.
−Removed: Forward-Looking
−Removed: statements contained in this Report are not statements of historical fact and are forward-looking statements within the meaning of Section
−Removed: 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
−Removed: Forward-looking statements give current expectations or forecasts of future events or our future financial or operating
−Removed: We may, in some cases, use words such as “anticipate,” “believe,” “could,” “estimate,”
−Removed: “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,”
−Removed: “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty
−Removed: of future events or outcomes to identify these forward-looking statements.
−Removed: forward-looking statements reflect our management’s beliefs and views with respect to future events, are based on estimates and
−Removed: assumptions as of the date of this Report and are subject to risks and uncertainties, many of which are beyond our control, that could
−Removed: cause our actual results to differ materially from those in these forward-looking statements.
−Removed: We discuss many of these risks in greater
−Removed: detail under Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended September 30, 2020 and our
−Removed: Quarterly Report on Form 10-Q for the quarter ended December 31, 2020, and subsequent reports filed with or furnished to the Securities
−Removed: and Exchange Commission (the “SEC”).
−Removed: Moreover, we operate in a very competitive and rapidly changing environment.
−Removed: emerge from time to time.
−Removed: It is not possible for our management to predict all risks, nor can we assess the impact of all factors on
−Removed: our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained
−Removed: in any forward-looking statements we may make.
−Removed: Given these uncertainties, you should not place undue reliance on these forward-looking
−Removed: forward-looking statement made by us in this Report speaks only as of the date hereof or as of the date specified herein.
−Removed: no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise,
−Removed: except as may be required by applicable laws or regulations.
−Removed: date, our primary activities have been limited to, and our limited resources have been dedicated to, performing business and financial
−Removed: planning, raising capital, recruiting personnel, negotiating with business partners and the licensors of our intellectual property and
−Removed: conducting research and development activities.
−Removed: Our Evo cortical technology (“cEEG”) has received 510(k) clearance from the
−Removed: FDA for recording, monitoring, and stimulating brain tissue for up to 30 days for which we have begun to generate revenue beginning in
−Removed: the first quarter of fiscal 2021 from the sale of products based on our Evo cortical technology.
−Removed: Our other products are still under development.
−Removed: have incurred losses since inception.
−Removed: As of June 30, 2021, we had an accumulated deficit of $38.2 million, primarily as a result of expenses
−Removed: incurred in connection with our research and development, selling, general and administrative expenses associated with our operations
−Removed: and interest expense, fair value adjustments and loss on extinguishments related to our debt, offset in part by collaborations and product
−Removed: We expect to continue to incur significant expenses and increasing operating and net losses for the foreseeable future until
−Removed: and unless we generate a higher level of revenue from commercial sales.
−Removed: main source of cash to date, outside of collaborations and product revenues, has been proceeds from the issuances of notes, common stock,
−Removed: warrants and unsecured loans.
−Removed: See “—Liquidity and Capital Resources—Historical Capital Resources” below.
−Removed: June 30, 2021, we had $9.0 million in cash deposits.
−Removed: Our existing cash and cash equivalents is not sufficient to fund our operating expenses
−Removed: through at least twelve months from the date of this filing.
−Removed: We will need to obtain substantial additional funding in connection with
−Removed: our continuing operations through public or private equity or debt financings or other sources such as additional product revenue and
−Removed: milestone payments from our current collaboration with Zimmer.
−Removed: However, we may be unable to raise additional funds when needed on favorable
−Removed: terms or at all.
−Removed: Our failure to raise such capital as and when needed would have a negative impact on our financial condition and our
−Removed: ability to develop and commercialize our cortical strip, grid electrode and depth electrode technology and future products and our ability
−Removed: to pursue our business strategy.
−Removed: See “—Liquidity and Capital Resources—Funding Requirements and Outlook” below.
−Removed: of Independent Registered Public Accounting Firm for Fiscal 2021
−Removed: June 18, 2021, the Audit Committee (the “Audit Committee”) of the Board of the Company (i) engaged Baker Tilly US, LLP (“Baker
−Removed: Tilly”) to serve as the Company’s independent registered public accounting firm for the Company’s fiscal year ending
−Removed: September 30, 2021, and (ii) determined to dismiss BDO USA, LLP (“BDO”), the Company’s independent registered
−Removed: public accounting firm for the year ending September 30, 2020 and the quarters ending December 31, 2020 and March 31, 2021.
−Removed: Medical Technologies Corporation
−Removed: Shelf Registration
−Removed: June 4, 2021, NeuroOne filed a Form S-3 shelf registration statement under the Securities Act, which was declared effective by the SEC
−Removed: on June 14, 2021 (the “2021 Shelf”) under which the Company may offer and sell, from time to time in its sole discretion,
−Removed: securities having an aggregate offering price of up to $150 million.
−Removed: Capital Market
−Removed: Company’s common stock commenced trading on The Nasdaq Capital Market on May 26, 2021 under the ticker symbol “NMTC.”
−Removed: Previously, the Company’s common stock was traded on the OTC Markets quotation system on the OTCQB.
−Removed: after the close of business on March 31, 2021, the Company completed a 1-for-3 reverse stock split of its common stock.
−Removed: All share and
−Removed: per share amounts in this Quarterly Report have been reflected on a post-split basis.
−Removed: Private Placement
−Removed: January 12, 2021, we entered into a Common Stock and Warrant Purchase Agreement (the “2021 Purchase Agreement”) with certain
−Removed: accredited investors (the “Purchasers”), pursuant to which the Company, in a private placement (the “2021 Private Placement”),
−Removed: agreed to issue and sell an aggregate of 4,166,682 shares (the “Shares”) of the common stock of the Company, and warrants
−Removed: to purchase an aggregate of 4,166,682 shares of common stock (the “2021 Warrants”) at an aggregate purchase price of $3.00
−Removed: per share of common stock and corresponding warrant, resulting in total gross proceeds of $12.5 million before deducting placement agent
−Removed: fees and offering expenses.
−Removed: The 2021 Warrants have an initial exercise price of $5.25 per share.
−Removed: See “— Liquidity and Capital
−Removed: Resources — Historical Capital Resources ” section below for additional information with regard to the 2021 Private
−Removed: March 11, 2020, the World Health Organization declared the outbreak of COVID-19 as a global pandemic.
−Removed: As a result of the COVID-19 pandemic,
−Removed: the Company has experienced, and will likely continue to experience, delays and disruptions in our pre-clinical and clinical trials,
−Removed: as well as interruptions in our manufacturing, supply chain, and research and development operations.
−Removed: The global outbreak of COVID-19
−Removed: continues to rapidly evolve.
−Removed: In April 2020, given the impact of COVID-19 on the Company, the Company applied for and received loan funding
−Removed: of $83,333 under the Paycheck Protection Program, which was forgiven by the U.S.
−Removed: Small Busing Administration on June 9, 2021.
−Removed: extent to which the COVID-19 pandemic may impact our business and pre-clinical and clinical trials will depend on future developments,
−Removed: which are highly uncertain and cannot be predicted with confidence, such as the effect of the pandemic on our suppliers and distributors
−Removed: and the global supply chain, the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social
−Removed: distancing in the U.S.
−Removed: and other countries, business closures or business disruptions and the effectiveness of actions taken in the U.S.
−Removed: and other countries to contain and treat the disease.
−Removed: The COVID-19 pandemic may also impact our business as a result of employee illness,
−Removed: school closures, and other community response measures.
−Removed: COVID-19 pandemic may also impact our ability to secure additional financing.
−Removed: Although the Company cannot estimate the length or gravity
−Removed: of the impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on the Company’s
−Removed: results of future operations, financial position, and liquidity in for the remainder of fiscal year 2021 and beyond.
−Removed: product revenue during the three and nine months ended June 30, 2021 was derived from the sale of strip/grid and electrode cable assembly
−Removed: products based on Evo cortical technology.
−Removed: For the foreseeable future, we anticipate that we will generate additional revenue from the
−Removed: sale of products based on Evo cortical technology.
−Removed: have received FDA 510(k) clearance for our cortical strip electrode, but we do not expect to generate any revenue from the sale of our
−Removed: other products until we develop and obtain all required regulatory approvals or clearances for and commercialize depth electrode technology.
−Removed: If we fail to complete the development of the depth electrode technology, or any other product candidate we may pursue in the future,
−Removed: in a timely manner, or fail to obtain regulatory approval, we may never be able to generate revenue from product sales sufficient to
−Removed: sustain operations.
−Removed: Medical Technologies Corporation
−Removed: gross loss represents our product revenue less our cost of product revenue.
−Removed: Our cost of product revenue consists of the manufacturing
−Removed: and materials costs incurred by our third-party contract manufacturer in connection with our Strip/Grid Products and outside supplier
−Removed: materials costs in connection with the Electrode Cable Assembly Products.
−Removed: In addition, cost of product revenue includes royalty fees
−Removed: incurred in connection with our license agreements.
−Removed: Collaborations
−Removed: Collaborations
−Removed: revenue was derived from the upfront initial exclusivity fee payment under the Zimmer Development Agreement.
−Removed: We anticipate that we may
−Removed: earn additional revenues stemming from additional milestone and royalty payments from Zimmer, however, the hitting of milestones or level
−Removed: of sales required to earn royalty payments is uncertain.
−Removed: General and Administrative
−Removed: general and administrative expenses consist primarily of personnel-related costs including stock-based compensation for personnel in
−Removed: functions not directly associated with research and development activities.
−Removed: Other significant costs include legal fees relating to corporate
−Removed: matters, intellectual property costs, professional fees for consultants assisting with regulatory, clinical, product development, financial
−Removed: matters, and beginning in the first quarter of fiscal year 2021, sales and marketing in connection with the commercial sale of cEEG strip/grid
−Removed: and electrode cable assembly products.
−Removed: We anticipate that our general and administrative expenses will significantly increase in the
−Removed: future to support our continued research and development activities, further commercialization of our cortical strip technology, potential
−Removed: commercialization of our grid electrode and depth electrode technology, if approved, and the increased costs of operating as a public
−Removed: These increases will include increased costs related to the hiring of additional personnel and fees for legal and professional
−Removed: services, as well as other public-company related costs.
−Removed: and Development
−Removed: and development expenses consist of expenses incurred in performing research and development activities in developing our cortical strip,
−Removed: grid electrode and depth electrode technology.
−Removed: Research and development expenses include compensation and benefits for research and development
−Removed: employees including stock-based compensation, overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing
−Removed: expenses, costs related to regulatory operations, fees paid to consultants and other outside expenses.
−Removed: Research and development costs
−Removed: are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed.
−Removed: Lastly, de minimis income
−Removed: from the sale of prototype products and related materials are offset against research and development expenses.
−Removed: expect our research and development expenses to significantly increase over the next several years as we develop our cortical strip,
−Removed: grid electrode and depth electrode technology and conduct preclinical testing and clinical trials and will depend on the duration, costs
−Removed: and timing to complete our preclinical programs and clinical trials.
−Removed: expense primarily consists of interest costs related to our 2019 Paulson Notes and 2020 Paulson Notes.
−Removed: valuation change of instruments measured at fair value
−Removed: net valuation change of instruments measured at fair value include the change in fair value of the 2019 Paulson Notes and 2020 Paulson
−Removed: on notes extinguishment
−Removed: on note extinguishment includes the loss associated with debt instrument modifications and conversions accounted for as debt extinguishments.
−Removed: of proceeds outside of normal operating activity relating to legal settlements and to the forgiveness of the paycheck protection program
−Removed: Medical Technologies Corporation
−Removed: of Operations
−Removed: of the Three Months Ended June 30, 2021 and 2020
−Removed: following table sets forth the results of operations for the three-months ended June 30, 2021 and 2020, respectively.
−Removed: three months ended
−Removed: of product revenue
−Removed: Collaborations
−Removed: general and administrative
+Added: Management’s Discussion and Analysis
+Added: of Financial Condition and Results of Operations
+Added: The following discussion of our financial
+Added: condition and results of operations should be read in conjunction with the financial statements and notes included in Part I “Financial
+Added: Information”, Item I “Financial Statements” of this Quarterly Report on Form 10-Q (the “Report”) and the
+Added: audited financial statements and related footnotes included in our Annual Report on Form 10-K for the year ended September 30, 2021.
+Added: Forward-Looking Statements
+Added: This Report contains forward-looking statements
+Added: that involve substantial risks and uncertainties.
+Added: In some cases, you can identify forward-looking statements by the words “may,”
+Added: “might,” “will,” “could,” “would,” “should,” “expect,” “intend,”
+Added: “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,”
+Added: “project,” “potential,” “target,” “seek,” “contemplate,” “continue”
+Added: and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the
+Added: These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of
+Added: activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.
+Added: Although we believe that we have a reasonable basis for each forward-looking statement contained in this Report, we caution you that
+Added: these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which
+Added: we cannot be certain.
+Added: Forward-looking statements include statements about:
+Added: the timing of and our ability
+Added: to obtain and maintain regulatory clearance of our cortical strip, grid and depth electrode technology;
+Added: even if our cortical strip,
+Added: grid electrode and depth electrode technology is approved for commercial sale, our ability to successfully commercialize our technology
+Added: in the United States;
+Added: our ability to achieve
+Added: or sustain profitability;
+Added: our ability to raise additional
+Added: capital and to fund our operations;
+Added: the availability of additional
+Added: capital on acceptable terms or at all as or when needed;
+Added: the clinical utility of
+Added: our cortical strip, grid and depth electrode including technology under development;
+Added: our ability to develop
+Added: additional applications of our cortical strip, grid and depth electrode technology with the benefits we hope to offer as compared
+Added: to existing technology, or at all;
+Added: the results of our development
+Added: and distribution relationship with Zimmer, Inc.
+Added: the performance, productivity,
+Added: reliability and regulatory compliance of our third party manufacturers of our cortical strip, grid electrode and depth electrode
+Added: our ability to develop
+Added: future generations of our cortical strip, grid and depth electrode technology;
+Added: our future development
+Added: the impact of the COVID-19
+Added: pandemic and resulting macroeconomic conditions, including supply chain disruptions, labor shortages and inflationary pressures,
+Added: on our business;
+Added: our ability to obtain reimbursement
+Added: coverage for our cortical strip, grid and depth electrode technology;
+Added: our expectations about
+Added: the willingness of healthcare providers to recommend our cortical strip, grid and depth electrode technology to people with epilepsy,
+Added: Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological
+Added: our future commercialization,
+Added: marketing and manufacturing capabilities and strategy;
+Added: our ability to comply with
+Added: applicable regulatory requirements;
+Added: our ability to maintain
+Added: our intellectual property position;
+Added: the outcome of legal proceedings
+Added: with PMT Corporation (“PMT”);
+Added: our expectations regarding
+Added: international opportunities for commercializing our cortical strip, grid and depth electrode technology under including technology
+Added: under development;
+Added: our estimates regarding
+Added: the size of, and future growth in, the market for our technology, including technology under development;
+Added: our estimates regarding
+Added: our future expenses and needs for additional financing.
+Added: Forward-looking statements are based on management’s
+Added: current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s
+Added: beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and
+Added: other factors that are in some cases beyond our control.
+Added: You should refer to the “Risk Factors” section of our Annual Report
+Added: on Form 10-K for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied
+Added: by our forward-looking statements.
+Added: As a result of these factors, we cannot assure you that the forward-looking statements in this Report
+Added: will prove to be accurate.
+Added: Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.
+Added: light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation
+Added: or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.
+Added: These forward-looking statements speak only as
+Added: of the date of this Report.
+Added: Except as required by law, we assume no obligation to update or revise these forward-looking statements for
+Added: any reason, even if new information becomes available in the future.
+Added: You should, however, review the factors and risks and other information
+Added: we describe in the reports we will file from time to time with the Securities and Exchange Commission (the “SEC”) after the
+Added: date of this Report.
+Added: We are a medical technology
+Added: company focused on the development and commercialization of thin film electrode technology for cEEG and sEEG recording, spinal cord stimulation,
+Added: brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors,
+Added: chronic pain due to failed back surgeries and other related neurological disorders.
+Added: Additionally, we are investigating the potential
+Added: applications of our technology associated with artificial intelligence
+Added: We are developing our
+Added: cortical, sheet and depth electrode technology to provide solutions for diagnosis through cEEG recording and sEEG recording and treatment
+Added: through brain stimulation and ablation, all in one product.
+Added: A cEEG is a continuous recording of the electrical activity of the brain
+Added: that identifies the location of irregular brain activity, which information is required for proper treatment.
+Added: cEEG recording involves
+Added: an invasive surgical procedure, referred to as a craniotomy.
+Added: sEEG involves a less invasive procedure whereby doctors place electrodes
+Added: in targeted brain areas by drilling small holes through the skull.
+Added: Both methods of seizure diagnosis are used to identify areas of the
+Added: brain where epileptic seizures originate in order to precisely locate the seizure source for therapeutic treatment if possible.
+Added: Deep brain stimulation,
+Added: or DBS, therapies involve activating or inhibiting the brain with electricity that can be given directly by electrodes on the surface
+Added: or implanted deeper in the brain via depth electrodes.
+Added: Introduced in 1987, this procedure involves implanting a power source referred
+Added: to as a neurostimulator, which sends electrical impulses through implanted depth electrodes, to specific targets in the brain for the
+Added: treatment of disorders such as Parkinson’s disease, essential tremors, dystonia, and chronic pain.
+Added: The effects of DBS as a potential
+Added: treatment for Alzheimer’s is also being evaluated by researchers.
+Added: Unlike ablative technologies, the effects of DBS are reversible.
+Added: RF ablation is a procedure
+Added: that uses radiofrequency under the electrode contacts which is directed to the site of the brain tissue that is targeted for removal.
+Added: The process involves delivering energy to the contacts, thereby heating them and destroying the brain tissue.
+Added: The ablation does not remove
+Added: Rather, it is left in place and typically scar tissue forms in the place where the ablation occurs.
+Added: This procedure is also
+Added: known as brain lesioning as it causes irreversible lesions.
+Added: We received 510(k)
+Added: FDA clearance for our Evo cortical technology in November 2019, and in September 2021 we received FDA clearance to market our Evo
+Added: sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the
+Added: recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
+Added: Our submission to the FDA seeking
+Added: 510(k) for use of our Evo sEEG electrode technology for up to 30 days was made in November 2021 and is pending.
+Added: responses on February 9, 2022 to questions from the FDA regarding our submission and the FDA acknowledged receipt of our response on
+Added: February 10, 2022.
+Added: The Company commenced commercial sales of cEEG strip/grid and electrode cable assembly products beginning in the
+Added: first quarter of fiscal year 2021.
+Added: The Company sold, on a limited application basis for design verification, sEEG depth electrode
+Added: products for non-human use in late fiscal year 2021 and the first quarter of fiscal year 2022.
+Added: Our other products are still under
+Added: Prior to FDA approval
+Added: or clearance of certain of our products, our primary activities were limited to, and our limited resources were dedicated to, performing
+Added: business and financial planning, raising capital, recruiting personnel, negotiating with business partners and the licensors of our intellectual
+Added: property and conducting research and development activities.
+Added: We have incurred losses
+Added: since inception.
+Added: As of December 31, 2021, we had an accumulated deficit of $43.6 million, primarily as a result of expenses incurred
+Added: in connection with our research and development, selling, general and administrative expenses associated with our operations and interest
+Added: expense, fair value adjustments and loss on extinguishments related to our debt, offset in part by collaborations and product revenues.
+Added: Prior to FDA approval
+Added: of certain of our products, our main source of cash was proceeds from the issuances of notes, common stock, warrants and unsecured loans.
+Added: See “—Liquidity and Capital Resources—Capital Resources” below.
+Added: While we have begun to generate revenue
+Added: from the sale of products based on our cEEG and sEEG technology and through milestone payments from our current collaboration with Zimmer, we
+Added: expect to continue to incur significant expenses and increasing operating and net losses for the foreseeable future until and unless
+Added: we generate a higher level of revenue from commercial sales, and we will need to obtain substantial additional funding in connection
+Added: with our continuing operations through public or private equity or debt financings, through collaborations or partnerships with other
+Added: companies or other sources.
+Added: We may be unable to
+Added: raise additional funds when needed on favorable terms or at all.
+Added: Our failure to raise such capital as and when needed would have a negative
+Added: impact on our financial condition and our ability to develop and commercialize our cortical strip, grid electrode and depth electrode
+Added: technology and future products and our ability to pursue our business strategy.
+Added: See “—Liquidity and Capital Resources—Liquidity
+Added: Outlook” below
+Added: Recent Developments and Upcoming Milestones
+Added: Corporate Updates
+Added: In November 2021, we
+Added: submitted a clearance request to the FDA for less than 30-day use of our Evo® sEEG Electrode, which has already been 510(k) cleared
+Added: for temporary (less than 24 hours) use, and our request is pending.
+Added: We expect to be commercial ready pending that approval.
+Added: Product shipment
+Added: following FDA clearance of our SEEG product family may also qualify the Company for an additional milestone payment from our distribution
+Added: partner Zimmer Biomet, who has placed initial stocking orders.
+Added: We completed feasibility
+Added: bench top testing with a new design of our diagnostic and ablation depth electrode in the first calendar quarter of 2021, and signed
+Added: a contract with RBC Medical Innovations to develop and manufacture hardware (a radio frequency generator) for the system in the third
+Added: calendar quarter of 2021.
+Added: We are targeting the third calendar quarter of 2022 for completion of a prototype of hardware and the submission
+Added: of an application for FDA clearance in early calendar 2023.
+Added: We also completed an animal feasibility study at Emory University in September
+Added: 2021 and additional animal studies are planned.
+Added: Subsequent to the end of the fiscal quarter, we also announced that we have surpassed
+Added: five years of accelerated aging testing for our recording electrodes.
+Added: On March 11, 2020, the World Health Organization
+Added: declared the outbreak of COVID-19 as a global pandemic.
+Added: COVID-19 and its variants continue to impact the United States and the world.
+Added: As a result of the COVID-19 pandemic, the Company has experienced delays and disruptions in our pre-clinical and clinical trials, as
+Added: well as interruptions in our manufacturing, supply chain, and research and development operations.
+Added: ● development of our technology has been and may continue to
+Added: be delayed in fiscal year 2021 and continuing into fiscal 2022 due to interruptions in global manufacturing and shipping as a result
+Added: of the COVID-19 pandemic and macroeconomic conditions, including as one of our key manufacturing partners and one of the Company’s
+Added: suppliers had staffing issues leading to delays in the Company’s development builds and delays in shipping product;
+Added: ● the Company’s own staff has been impacted by infections
+Added: and mandatory quarantines;
+Added: ● the Company is currently experiencing and may continue to
+Added: experience product shortages of its primary component, polyimide film, due to supply chain shortages attributed to COVID related issues;
+Added: ● the Company is experiencing and may continue to experience
+Added: delays in timelines for product availability and delivery from vendors, including related to staffing shortages, both generally and due
+Added: to employee illness, and due to increases in demand from other larger or more longstanding customers of our suppliers placing large orders
+Added: due to concerns with supply chain disruption and the impact of COVID-19.
+Added: The Company’s plans for further testing
+Added: or clinical trials and costs to obtain components may be further impacted by the continuing effects of COVID-19, supply chain challenges
+Added: and inflationary pressures.
+Added: The global outbreak of COVID-19 continues to
+Added: rapidly evolve as new variants emerge.
+Added: The extent to which the COVID-19 pandemic may impact our business and pre-clinical and clinical
+Added: trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the effect of
+Added: the pandemic on our suppliers and distributors and the global supply chain, the impact of inflation, the ultimate geographic spread of
+Added: the disease and its variants, the duration of the outbreak, travel restrictions and social distancing in the U.S.
+Added: and other countries,
+Added: business closures or business disruptions and the effectiveness of actions taken in the U.S.
+Added: and other countries to contain and treat
+Added: The COVID-19 pandemic may also impact our ability
+Added: to secure additional financing.
+Added: Although the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at
+Added: this time, if the pandemic continues, it may have a material adverse effect on the Company’s results of future operations, financial
+Added: position, and liquidity in fiscal year 2022 and beyond.
+Added: Financial Overview
+Added: Product Revenue
+Added: Our product revenue was derived from the sale
+Added: of strip/grid, depth electrode and electrode cable assembly products based on Evo cortical and sEEG technology.
+Added: For the foreseeable future,
+Added: we anticipate that we will generate additional revenue from the sale of products based on Evo cortical and sEEG technology.
+Added: We have received FDA 510(k) clearance for our
+Added: cortical strip electrode, but we do not expect to generate any significant revenue from the sale of our other products until we develop
+Added: and obtain all required regulatory approvals or clearances for and commercialize depth electrode technology for human use.
+Added: to complete the development of the depth electrode technology, or any other product candidate we may pursue in the future, in a timely
+Added: manner, or fail to obtain regulatory approval, we may never be able to generate revenue from product sales sufficient to sustain operations.
+Added: Product Gross Profit (Loss)
+Added: Product gross profit (loss) represents our product
+Added: revenue less our cost of product revenue.
+Added: Our cost of product revenue consists of the manufacturing and materials costs incurred by our
+Added: third-party contract manufacturer in connection with our strip/grid and depth electrode products and outside supplier materials costs
+Added: in connection with the electrode cable assembly products.
+Added: In addition, cost of product revenue includes royalty fees incurred in connection
+Added: with our license agreements.
+Added: Collaborations Revenue
+Added: Collaborations revenue was derived from the upfront
+Added: initial exclusivity fee payment under the Zimmer Development Agreement.
+Added: We anticipate that we may earn additional revenues stemming from
+Added: additional milestone and royalty payments from Zimmer, however, the achievement and timing of future milestones or level of sales required
+Added: to earn royalty payments from Zimmer is uncertain.
+Added: For a discussion of milestones and royalty payments under the Zimmer Development Agreement,
+Added: see “—Liquidity and Capital Resources—Liquidity Outlook” below and see “Note 7 — Zimmer Development
+Added: Agreement” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
+Added: in this Report.
+Added: Selling, General and Administrative
+Added: Selling, general and administrative expenses
+Added: consist primarily of personnel-related costs including stock-based compensation for personnel in functions not directly associated with
+Added: research and development activities.
+Added: Other significant costs include legal fees relating to corporate matters, intellectual property
+Added: costs, professional fees for consultants assisting with financial and administrative matters, and sales and marketing in connection with
+Added: the commercial sale of cEEG strip/grid, sEEG depth electrode and electrode cable assembly products.
+Added: We anticipate that our selling, general
+Added: and administrative expenses will significantly increase in the future to support our continued research and development activities, further
+Added: commercialization of our cortical strip technology, potential further commercialization of our grid electrode and depth electrode technology,
+Added: if approved, and the increased costs of operating as a public company.
+Added: These increases will include increased costs related to the hiring
+Added: of additional personnel and fees for legal and professional services, as well as other public-company related costs.
+Added: Research and Development
+Added: Research and development expenses consist of
+Added: expenses incurred in performing research and development activities in developing our cortical strip, grid electrode and depth electrode
+Added: Research and development expenses include compensation and benefits for research and development employees including stock-based
+Added: compensation, overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related
+Added: to regulatory operations, fees paid to consultants and other outside expenses.
+Added: Research and development costs are expensed as incurred
+Added: and costs incurred by third parties are expensed as the contracted work is performed.
+Added: Lastly, de minimis income from the sale of prototype
+Added: products and related materials are offset against research and development expenses.
+Added: We expect our research and development expenses
+Added: to significantly increase over the next several years as we develop our cortical strip, grid electrode and depth electrode technology
+Added: and conduct preclinical testing and clinical trials and will depend on the duration, costs and timing to complete our preclinical programs
+Added: and clinical trials.
+Added: Interest Expense
+Added: Interest expense consists of interest costs related
+Added: to our convertible notes issued in 2019 (the “2019 Paulson Notes”) outstanding during the first quarter of fiscal year 2021.
+Added: Net valuation change of instruments measured
+Added: at fair value
+Added: The net valuation change of instruments measured
+Added: at fair value include the change in fair value of the 2019 Paulson Notes outstanding during the first quarter of fiscal year 2021.
+Added: Other income primarily consists of interest income
+Added: related to our cash deposits and proceeds outside of normal operating activity relating to legal settlements.
+Added: Results of Operations
+Added: Comparison of the Three Months Ended December 31, 2021 and 2020
+Added: The following table sets forth the results of
+Added: operations for the three-months ended December 31, 2021 and 2020, respectively.
+Added: the three months ended
+Added: Product revenue
+Added: Cost of product revenue
+Added: Product gross profit (loss)
+Added: Collaborations revenue
+Added: Operating expenses:
+Added: Selling, general
+Added: and administrative
and development
operating expenses
−Removed: from operations
−Removed: Net valuation
−Removed: change of instruments measured at fair value
−Removed: on note extinguishment
−Removed: before income taxes
+Added: Loss from operations
+Added: Interest expense
+Added: Net valuation change
+Added: of instruments measured at fair value
+Added: Loss before income
for income taxes
1 unchanged sentence
$ (1,959,480 )
−Removed: Revenue and Product Gross Loss
−Removed: revenue and product gross loss was $40,000 and $(62,000), respectively, during the three months ended June 30, 2021.
−Removed: The product revenue
−Removed: during the second quarter related to the sale of our Strip/Grid Products and Electrode Cable Assembly Products.
−Removed: Cost of product revenue
−Removed: consisted of the manufacturing and materials costs incurred by our third-party contract manufacturer in connection with our Strip/Grid
−Removed: Products and outside supplier materials costs in connection with the Electrode Cable Assembly Products.
−Removed: In addition, cost of product
−Removed: revenue included royalty fees incurred in connection with our license agreements of approximately $26,000.
−Removed: There was no product revenue
−Removed: or product gross loss recognized during the comparable prior year period.
−Removed: Collaborations
−Removed: Collaborations
−Removed: revenue was $17,000 for the three months ended June 30, 2021.
−Removed: Revenue during the period was derived from the Zimmer Development Agreement
−Removed: and represented the portion of the upfront initial development fee payment eligible for revenue recognition during the third quarter
−Removed: of fiscal year 2021.
−Removed: The amount of revenue recognized related to the upfront fee was based on development completed in connection with
−Removed: SEEG Products, and to a lesser extent, the Strip/Grid Products.
−Removed: There was no collaborations revenue recognized during the comparable
−Removed: prior year period.
−Removed: general and administrative expenses
−Removed: general and administrative expenses were $2.1 million for the three months ended June 30, 2021, compared to $1.1 million for the three
−Removed: months ended June 30, 2020.
−Removed: The $1.0 million increase was primarily due to an increase in sales and marketing expenses of $0.2 million,
−Removed: stock-based compensation of $0.5 million, payroll related costs of $0.2 million and public company related costs of $0.1 million in the
−Removed: current quarter when compared to the prior year period.
−Removed: Medical Technologies Corporation
−Removed: and development expenses
−Removed: and development expenses were $0.9 million for the three months ended June 30, 2021, compared to $0.4 million during for the three months
−Removed: ended June 30, 2020.
−Removed: The $0.5 million increase period over period was attributed to supporting development activities, which primarily
−Removed: included salary-related expenses and costs related to consulting services, materials and supplies associated with the development of
−Removed: SEEG Products and to a lesser extent Strip/Grid Products.
−Removed: expense for the three months ended June 30, 2020 was attributed to non-cash interest expense in connection with our 2020 Paulson Notes
−Removed: and a nominal amount related to the 2019 Paulson Notes, both of which are described further below, and was comprised of issuance costs
−Removed: of $1.0 million and day-one interest at issuance of $3.8 million representing the amount by which fair value exceeded the 2020 Paulson
−Removed: Note proceeds.
−Removed: Interest on principal in connection with the 2019 Paulson Notes and 2020 Paulson Notes is included in the net valuation
−Removed: change of instruments measured at fair value line item.
−Removed: During the three months ended June 30, 2021, no interest expense was incurred
−Removed: as there was no debt outstanding.
−Removed: valuation change of instruments measured at fair value:
−Removed: net valuation change of instruments measured at fair value for the 2019 Paulson Notes for the three months ended June 30, 2021 and 2020
−Removed: was none and a benefit of $1.3 million, respectively.
−Removed: The change was due to accrued interest on the 2019 Paulson Notes and due to fluctuations
−Removed: in our common stock fair value and the number of potential shares of common stock issuable upon conversion of the 2019 Paulson Notes
−Removed: while outstanding.
−Removed: on note extinguishment
−Removed: loss on note extinguishment for the three months ended June 30, 2020 was $2.0 million.
−Removed: The 2019 Paulson notes were amended on April 24,
−Removed: 2020 to add a 40% discount to the optional conversion feature and to extend the maturity date by six months.
−Removed: The April 2020 amendment
−Removed: was accounted for as a note extinguishment given the significant modification made to the optional conversion feature.
−Removed: There were no
−Removed: note extinguishments during the three months ended June 30, 2021.
−Removed: income during the three months ended June 30, 2021 consisted of the forgiveness of the paycheck protection program loan in the amount
+Added: Product Revenue and Product Gross Profit (Loss)
+Added: Product revenue was $34,000 and $71,000 during
+Added: the three months ended December 31, 2021 and 2020, respectively.
+Added: Product gross profit (loss) was $(13,000) and $(38,000) during the three
+Added: months ended December 31, 2021 and 2020, respectively.
+Added: The product revenue consists of the sale of our strip/grid, depth electrode and
+Added: electrode cable assembly products.
+Added: Cost of product revenue consisted of the manufacturing and materials costs incurred by our third-party
+Added: contract manufacturer in connection with our strip/grid and depth electrode products, and outside supplier materials costs in connection
+Added: with the electrode cable assembly products.
+Added: In addition, cost of product revenue included royalty fees incurred of $26,000 and $52,000
+Added: in connection with our license agreements during the three months ended December 31, 2021 and 2020, respectively.
+Added: Collaborations Revenue
+Added: Collaborations revenue was $6,000 and $22,000
+Added: for the three months ended December 31, 2021 and 2020, respectively.
+Added: Revenue during each period was derived from the Zimmer Development
+Added: Agreement and represented the portion of the upfront initial development fee payment eligible for revenue recognition during such period.
+Added: The amount of revenue recognized related to the upfront fee was based on development completed in connection with depth electrode products,
+Added: and to a lesser extent, the strip/grid products.
+Added: Selling, general and administrative expenses
+Added: Selling, general and administrative expenses
+Added: were $1.7 million for the three months ended December 31, 2021, compared to $1.2 million for the three months ended December 31, 2020.
+Added: The $0.5 million increase was primarily due to an increase in legal costs of $0.3 million, sales and marketing of $0.1 million and operating
+Added: costs of $0.1 million on a net basis.
+Added: Research and development expenses
+Added: Research and development expenses were $1.1 million
+Added: for the three months ended December 31, 2021, compared to $0.9 million during for the three months ended December 31, 2020.
+Added: million increase period over period was attributed to supporting development activities, which primarily included salary-related expenses
+Added: and costs related to consulting services, materials and supplies associated with the development of depth electrode products and to a
+Added: lesser extent strip/grid products.
+Added: Interest expense
+Added: Interest expense for the three months ended December
+Added: 31, 2020 was $3,000 and consisted of issuance costs in connection with our 2019 Paulson Notes.
+Added: The 2019 Paulson Notes were not
+Added: outstanding and there was no interest expense during the three month period ended December 31, 2021.
+Added: Net valuation change of instruments measured
+Added: at fair value:
+Added: The net valuation change of instruments measured
+Added: at fair value for the 2019 Paulson Notes for the three months ended December 31, 2020 was a benefit of $2,000.
+Added: The change was due to
+Added: accrued interest on the 2019 Paulson Notes and due to fluctuations in our common stock fair value and the number of potential shares
+Added: of common stock issuable upon conversion of the 2019 Paulson Notes while outstanding.
+Added: There was no net valuation change of instruments
+Added: measured at fair value during the three month period ended December 31, 2021 as the 2019 Paulson Notes were not outstanding.
+Added: Other income during the three month period ended
+Added: December 31, 2021 consisted of $2,000 related primarily to interest income attributed to our cash deposits.
+Added: Other income during the three
+Added: months ended December 31, 2020 consisted primarily of proceeds received in connection with the PMT Corporation litigation in the amount
of $0.2 million.
−Removed: We did not have other income during the comparable prior year period.
−Removed: Medical Technologies Corporation
−Removed: of the Nine Months Ended June 30, 2021 and 2020
−Removed: following table sets forth the results of operations for the nine months ended June 30, 2021 and 2020, respectively.
−Removed: nine months ended
−Removed: product revenue
−Removed: Collaborations
−Removed: general and administrative
−Removed: and development
−Removed: operating expenses
−Removed: Net valuation
−Removed: change of instruments measured at fair value
−Removed: note extinguishment
−Removed: for income taxes
−Removed: Revenue and Product Gross Loss
−Removed: revenue and product gross loss was $0.1 million and $(0.2) million during the nine months ended June 30, 2021, respectively.
−Removed: revenue consisted of Strip/Grid Products and Electrode Cable Assembly Products sales.
−Removed: Cost of product revenue consisted of the manufacturing
−Removed: and materials costs incurred by our third-party contract manufacturer in connection with our Strip/Grid Products and outside supplier
−Removed: materials costs in connection with the Electrode Cable Assembly Products.
−Removed: In addition, cost of product revenue included royalty fees
−Removed: incurred, including the royalty fees to WARF and Mayo of $0.1 million in connection with our license agreements.
−Removed: There was no product
−Removed: revenue or product gross loss recognized during the comparable prior year period.
−Removed: Collaborations
−Removed: Collaborations
−Removed: revenue was $60,000 for the nine months ended June 30, 2021.
−Removed: Revenue during the period was derived from the Zimmer Development Agreement
−Removed: and represented the portion of the upfront initial development fee payment eligible for revenue recognition during the nine months ended
−Removed: June 30, 2021.
−Removed: The amount of revenue recognized related to the upfront fee was based on development completed in connection with SEEG
−Removed: products, and to a lesser extent, the Strip/Grid Products.
−Removed: There was no collaborations revenue recognized during the comparable prior
−Removed: general and administrative expenses
−Removed: general and administrative expenses were $4.6 million for the nine months ended June 30, 2021, compared to $3.5 million for the nine
−Removed: months ended June 30, 2020.
−Removed: The $1.1 million increase was primarily due to an increase in sales and marketing expenses of $0.7 million,
−Removed: payroll related costs of $0.2 million, public company and governance costs of $0.4 million and other operating expenses and fees of $0.1
−Removed: million, offset in part by a decrease in stock-based compensation of $0.1 million and legal costs of $0.2 million.
−Removed: and development expenses
−Removed: and development expenses were $2.9 million for the nine months ended June 30, 2021, compared to $1.3 million during for the nine months
−Removed: ended June 30, 2020.
−Removed: The $1.6 million increase period over period was attributed to supporting development activities, which primarily
−Removed: included salary-related expenses and costs related to consulting services, materials and supplies associated with the development of
−Removed: SEEG Products and to a lesser extent Strip/Grid Products.
−Removed: Medical Technologies Corporation
−Removed: expense for the nine months ended June 30, 2021 was $3,000 and consisted of issuance costs in connection with our 2019 Paulson Notes
−Removed: described further below.
−Removed: expense during the nine months ended June 30, 2020 was primarily attributed to non-cash interest expense in connection with our 2019
−Removed: Paulson Notes and 2020 Paulson Notes.
−Removed: Interest expense attributed to the 2019 Paulson Notes and 2020 Paulson Notes was comprised of issuance
−Removed: costs of $1.8 million and day-one interest at issuance of $5.6 million representing the amount by which fair value exceeded note proceeds.
−Removed: Interest on principal in connection with the 2019 Paulson Notes and 2020 Paulson Notes is included in the net valuation change of
−Removed: instruments measured at fair value line item.
−Removed: valuation change of instruments measured at fair value:
−Removed: net valuation change of instruments measured at fair value for the 2019 Paulson Notes for the nine months ended June 30, 2021 and 2020
−Removed: was a benefit of $2,000 and $1.2 million, respectively.
−Removed: The change was due to accrued interest on the 2019 Paulson Notes and due to fluctuations
−Removed: in our common stock fair value and the number of potential shares of common stock issuable upon conversion of the 2019 Paulson Notes
−Removed: while outstanding.
−Removed: on note extinguishment
−Removed: loss on note extinguishment for the nine months ended June 30, 2020 was $2.0 million.
−Removed: The 2019 Paulson notes were amended on April 24,
−Removed: 2020 (the “April 2020 Amendment”) to add a 40% discount to the optional conversion feature and to extend the maturity date
−Removed: by six months.
−Removed: The April 2020 Amendment was accounted for as a note extinguishment given the significant modification made to the optional
−Removed: conversion feature.
−Removed: There were no note extinguishments during the nine months ended June 30, 2021.
−Removed: income during the nine months ended June 30, 2021 consisted principally of proceeds received in connection with the PMT Corporation litigation
−Removed: in the amount of $0.2 million and the forgiveness of the paycheck protection program loan in the amount of $0.1 million.
−Removed: We did not have
−Removed: other income during the comparable prior year period.
−Removed: and Capital Resources
−Removed: Capital Resources
−Removed: of June 30, 2021, our principal source of liquidity consisted of cash deposits of $9.0 million.
−Removed: We have just begun to generate revenue
−Removed: from commercial sales during the first quarter of fiscal year 2021, and we anticipate that we will continue to incur losses for the foreseeable
−Removed: future until and unless we generate an adequate level of revenue from commercial sales to cover expenses.
+Added: Liquidity and Capital Resources
+Added: As of December 31, 2021, our principal source
+Added: of liquidity consisted of cash deposits of $16.2 million.
+Added: While we began to generate revenue in fiscal year 2021 from commercial sales
+Added: and through milestone payments under our collaboration with Zimmer, we expect to continue to incur significant expenses and increasing
+Added: operating and net losses for the foreseeable future until and unless we generate an adequate level of revenue from commercial sales to
+Added: cover expenses.
+Added: Our most significant cash requirements relate to the funding of our ongoing product development and commercialization
+Added: operations and our royalty obligations under our intellectual property licenses with the Wisconsin Alumni Research Foundation (“WARF”)
+Added: and the Mayo Foundation for Medical Education and Research (“Mayo”).
+Added: Our additional material cash needs include commitments
+Added: under operating leases and other administrative services.
+Added: See “—Funding Requirements” below for more information.
anticipate that our expenses will increase substantially as we develop and commercialize our cortical strip, grid electrode and depth
−Removed: electrode technology and pursue pre-clinical and clinical trials, seek regulatory approvals, contract to manufacture any products, establish
−Removed: our own sales, marketing and distribution infrastructure to commercialize our cortical strip, grid electrode and depth electrode technology
−Removed: under development, if approved, hire additional staff, add operational, financial and management systems and continue to operate as a
−Removed: public company.
−Removed: source of cash, outside of collaboration and product revenues, to date has been proceeds from the issuances of notes with warrants, common
−Removed: stock with and without warrants and unsecured loans, the terms of which are further described below.
−Removed: See also “—Funding Requirements
−Removed: and Outlook” below.
−Removed: Private Placement
−Removed: January 12, 2021, we entered into the “2021 Purchase Agreement with certain accredited investors, pursuant to which the Company,
−Removed: in a private placement (the “2021 Private Placement”), agreed to issue and sell an aggregate of 4,166,682 shares (the “Shares”)
−Removed: of the common stock of the Company, and warrants to purchase an aggregate of 4,166,682 shares of common stock (the “2021 Warrants”)
−Removed: at an aggregate purchase price of $3.00 per share of common stock and corresponding warrant, resulting in total gross proceeds of $12.5
−Removed: million before deducting placement agent fees and estimated offering expenses.
−Removed: The 2021 Warrants have an initial exercise price of $5.25
−Removed: The 2021 Warrants became immediately exercisable beginning on the date of issuance and will expire on the fifth anniversary
−Removed: of such date.
−Removed: Prior to expiration, subject to the terms and conditions set forth in the 2021 Warrants, the holders of such 2021 Warrants
−Removed: may exercise the 2021 Warrants for shares of common stock by providing notice to the Company and paying the exercise price per share
−Removed: for each share so exercised or by utilizing the “cashless exercise” feature contained in each 2021 Warrant.
−Removed: The 2021 Private
−Removed: Placement closed on January 14, 2021.
−Removed: connection with the 2021 Private Placement, the Company agreed to file a registration statement with the SEC covering the resale of the
−Removed: Shares, the 2021 Warrants and the shares of common stock issuable upon exercise of the 2021 Warrants.
−Removed: The Company has agreed to file
−Removed: such registration statement within 30 days of the execution of the 2021 Purchase Agreement on January 12, 2021 and filed such registration
−Removed: statement on February 10, 2021.
−Removed: Medical Technologies Corporation
−Removed: Stock Offerings
−Removed: July 24, 2020, we entered into a Securities Purchase Agreement (“2020 Purchase Agreement”) with an accredited investor pursuant
−Removed: to which we, in a private placement, issued and sold 25,000 shares of the Company’s common stock for gross proceeds in the amount
−Removed: Under the 2020 Purchase Agreement, we agreed to use the net proceeds from the private placement for funding operations or
−Removed: working capital and general corporate purposes.
−Removed: We granted the investor indemnification rights with respect to representations, warranties
−Removed: and agreements under the 2020 Purchase Agreement.
−Removed: October 23, 2019, the Company entered into Securities Purchase Agreements with certain accredited investors, pursuant to which the Company,
−Removed: in a private placement, issued and sold 47,223 shares of the Company’s common stock to the accredited investors at a price of $5.40
−Removed: per share, for gross proceeds amounting to $0.3 million before deducting offering expenses.
−Removed: The Company filed a registration statement
−Removed: with the SEC covering the resale of the shares of common stock sold in the private placement on August 11, 2020.
−Removed: Paulson Convertible Notes
−Removed: April 30, 2020, the Company entered into a subscription agreement with certain accredited investors, pursuant to which the Company, in
−Removed: a private placement (the “2020 Paulson Private Placement”), agreed to issue and sell to the investors 13% convertible promissory
−Removed: notes (each, a “2020 Paulson Note” and collectively, the “2020 Paulson Notes”) and warrants (each, a “2020
−Removed: Paulson Warrant” and collectively, the “2020 Paulson Warrants”) to purchase shares of the Company’s common stock.
−Removed: April 30, 2020 and June 30, 2020, the Company issued 2020 Paulson Notes in an aggregate principal amount of $5.1 million to the Subscribers.
−Removed: The final closing under the 2020 Paulson Private Placement occurred on June 30, 2020.
−Removed: In July 2020, all remaining 2020 Paulson Notes
−Removed: outstanding were automatically converted into common stock following the announcement of a Strategic Transaction (as defined in the 2020
−Removed: Paulson Notes) with Zimmer, Inc.
−Removed: Refer to “—Liquidity and Capital Resources—Historical Capital Resources” in
−Removed: our Annual Report on Form 10-K for the year ended September 30, 2020 for additional information related to the 2020 Paulson Convertible
−Removed: Paulson Convertible Notes
−Removed: November 1, 2019, the Company entered into a subscription agreement with certain accredited investors, pursuant to which the Company,
−Removed: in a private placement (the “2019 Paulson Private Placement”), agreed to issue and sell to the investors 13% convertible
−Removed: promissory notes (each, a “2019 Paulson Note” and collectively, the “2019 Paulson Notes”) and warrants (each,
−Removed: a “2019 Paulson Warrant” and collectively, the “2019 Paulson Warrants”) to purchase shares of the Company’s
−Removed: common stock.
−Removed: initial closing of the private placement was consummated on November 1, 2019, and, on that date and through December 3, 2019, the Company
−Removed: issued 2019 Paulson Notes in an aggregate principal amount of $3,234,800 to the Subscribers for gross proceeds equaling the principal
−Removed: The private placement terminated on December 3, 2019.
−Removed: Between April 24, 2020 and December 15, 2020, all of the holders elected
−Removed: to convert outstanding principal and accrued and unpaid interest of 2019 Paulson Notes in the amount of $3,453,883 into shares of common
−Removed: Refer to “—Liquidity and Capital Resources—Historical Capital Resources” in our Annual Report on Form
−Removed: 10-K for the year ended September 30, 2020 for additional information related to the 2019 Paulson Convertible Notes.
−Removed: Protection Program Loan
−Removed: connection with the CARES Act, the Company received loan funding of approximately $83,000 under the Paycheck Protection Program (“PPP”),
−Removed: which was forgiven by the U.S.
−Removed: Small Business Administration on June 9, 2021.
−Removed: Prior to Fiscal Year 2020
−Removed: sources of cash prior to fiscal year 2020 were generated from the following financing arrangements:
−Removed: Unit Private Placement
−Removed: December 28, 2018 through July 1, 2019, the Company entered into Subscription Agreements (each, a “2019 Purchase Agreement”)
−Removed: with certain accredited investors (the “New Purchasers”), pursuant to which the Company, in a new private placement (the
−Removed: “2019 Unit Private Placement”), agreed to issue and sell Units (the “2019 Units”), each consisting of (i) one
−Removed: share of common stock and (ii) a warrant to purchase one share of common stock for total gross proceeds to the Company of $5,845,448
−Removed: before deducting offering expenses.
−Removed: Refer to “—Liquidity and Capital Resources—Historical Capital Resources”
−Removed: in our Annual Report on Form 10-K for the year ended September 30, 2020 for additional information related to the 2019 Unit Private Placement.
−Removed: Medical Technologies Corporation
−Removed: Private Placement
−Removed: July 9, 2018 through November 30, 2018 (the final closing), the Company entered into subscription agreements (each, a “Purchase
−Removed: Agreement”) with certain accredited investors (the “Purchasers”), pursuant to which the Company, in a private placement
−Removed: (the “2018 Private Placement”), agreed to issue and sell to the Purchasers units (each, a “2018 Unit”), each
−Removed: consisting of (i) one share of common stock and (ii) a warrant to purchase one share of common stock for total gross proceeds to the
−Removed: Company of $1,538,000 before deducting offering expenses.
−Removed: Refer to “—Liquidity and Capital Resources—Historical Capital
−Removed: Resources” in our Annual Report on Form 10-K for the year ended September 30, 2020 for additional information related to the 2018
+Added: electrode technology and pursue pre-clinical and clinical trials, seek regulatory approvals, manufacture products, establish our own
+Added: sales, marketing and distribution infrastructure to commercialize our ablation electrode technology, hire additional staff, add operational,
+Added: financial and management systems and continue to operate as a public company.
+Added: Capital Resources
+Added: Our sources of cash to date have been limited
+Added: collaboration and product revenues and proceeds from the issuances of notes with warrants, common stock with and without warrants and
+Added: unsecured loans, with the terms of our most recent financings described below.
+Added: October 2021 Underwritten Public Offering
+Added: On October 13, 2021, we entered into Underwriting
+Added: Agreement relating to the issuance and sale of 3,750,000 shares of our common stock at a price to the public of $3.20 per share.
+Added: under the terms of the Underwriting Agreement, we granted the Underwriter an option, exercisable for 30 days, to purchase up to an additional
+Added: 562,500 shares of common stock on the same terms.
+Added: The base offering closed on October 15, 2021, and the sale of 422,057 shares of common
+Added: stock subject to the Underwriter’s overallotment option closed on November 15, 2021.
+Added: The gross proceeds from this offering were
+Added: approximately $13.4 million prior to deducting underwriting discounts and other offering expenses payable by us.
2021 Private Placement
−Removed: 3 Notes and Warrants (2017 Convertible Notes)
−Removed: October 2017 to May 2018, the Company issued convertible notes (the “Series 3 Notes” or “2017 Convertible Notes”)
−Removed: in an aggregate principal amount of $1.5 million that bear interest at a fixed rate of 8% per annum and warrants to purchase shares of
−Removed: the Company’s capital stock (the “Series 3 Warrants”).
−Removed: On February 28, 2019, the outstanding principal and interest
−Removed: on the Series 3 Notes converted into shares of common stock and common stock purchase warrants.
−Removed: Refer to “—Liquidity and
−Removed: Capital Resources—Historical Capital Resources” in our Annual Report on Form 10-K for the year ended September 30, 2020 for
−Removed: additional information related to the Series 3 Notes and Warrants (2017 Convertible Notes).
−Removed: 2 Notes and Warrants
−Removed: August 2017, the Company entered into a subscription agreement in an aggregate principal amount of $253,000 to certain accredited investors
−Removed: (the “Series 2 Notes”).
−Removed: On July 2, 2018, the Series 2 Notes were converted into shares of common stock and warrants.
−Removed: to “—Liquidity and Capital Resources—Historical Capital Resources” in our Annual Report on Form 10-K for the
−Removed: year ended September 30, 2020 for additional information related to the Series 2 Notes and warrants.
−Removed: 1 Notes and Warrants
−Removed: November 2016 to June 2017, the Company issued convertible promissory notes in an aggregate principal amount of $1.6 million and warrants
−Removed: to purchase shares of the Company’s capital stock (the “Series 1 Notes”).
−Removed: The Series 1 Notes were converted into shares
−Removed: of common stock and warrants.
−Removed: Refer to “—Liquidity and Capital Resources—Historical Capital Resources” in our
−Removed: Annual Report on Form 10-K for the year ended September 30, 2020 for additional information related to the Series 1 Notes and warrants.
−Removed: March 2018 to December 2018, the Company received gross proceeds from unsecured loans in the amount of $528,000.
−Removed: The unsecured loans
−Removed: were repaid in full as of June 30, 2019.
−Removed: Requirements and Outlook
−Removed: June 30, 2021, we had approximately $9.0 million in cash deposits.
−Removed: Our existing cash and cash is not sufficient to fund our operating
+Added: On January 12, 2021, we entered into a purchase
+Added: agreement with certain accredited investors, pursuant to which the Company, in a private placement (the “2021 Private Placement”),
+Added: agreed to issue and sell an aggregate of 4,166,682 shares (the “Shares”) of the common stock of the Company, and warrants
+Added: to purchase an aggregate of 4,166,682 shares of common stock (the “2021 Warrants”) at an aggregate purchase price of $3.00
+Added: per share of common stock and corresponding warrant, resulting in total gross proceeds of $12.5 million before deducting placement agent
+Added: fees and estimated offering expenses.
+Added: The 2021 Warrants have an initial exercise price of $5.25 per share.
+Added: The 2021 Warrants became immediately
+Added: exercisable beginning on the date of issuance and will expire on the fifth anniversary of such date.
+Added: Prior to expiration, subject to
+Added: the terms and conditions set forth in the 2021 Warrants, the holders of such 2021 Warrants may exercise the 2021 Warrants for shares
+Added: of common stock by providing notice to the Company and paying the exercise price per share for each share so exercised or by utilizing
+Added: the “cashless exercise” feature contained in each 2021 Warrant.
+Added: The 2021 Private Placement closed on January 14, 2021.
+Added: In connection with the 2021 Private Placement,
+Added: the Company agreed to file a registration statement with the SEC covering the resale of the Shares, the 2021 Warrants and the shares
+Added: of common stock issuable upon exercise of the 2021 Warrants.
+Added: The Company agreed to file such registration statement within 30 days of
+Added: the execution of the 2021 Purchase Agreement on January 12, 2021 and filed such registration statement on February 10, 2021.
+Added: Funding Requirements
+Added: As noted above, certain of our cash requirements
+Added: relate to the funding of our ongoing product development and commercialization operations and our milestone and royalty obligations under
+Added: our intellectual property licenses with the Wisconsin Alumni Research Foundation (“WARF”) and the Mayo Foundation for Medical
+Added: Education and Research (“Mayo”).
+Added: See “Item 1—Business—Clinical Development and Regulatory Pathway—Clinical
+Added: Experience, Future Development and Clinical Trial Plans” in our Annual Report on Form 10-K for the year ended September 30, 2021
+Added: for a discussion of design, development, pre-clinical and clinical activities that we may conduct in the future, including expected cash
+Added: expenditures required for some of those activities, to the extent we are able to estimate such costs.
+Added: On January 22, 2020, we entered into an Amended
+Added: and Restated License Agreement (the “WARF License”) with WARF, which amended and restated in full our prior license agreement
+Added: with WARF, dated October 1, 2014 (the “Original WARF License”).
+Added: Under the WARF License, we have agreed to pay WARF a royalty
+Added: equal to a single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000
+Added: for 2020, $100,000 for 2021 and $150,000 for 2022 and each calendar year thereafter that the WARF License is in effect.
+Added: of our sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency of such contest
+Added: and, if the contested patent is found to be valid and would be infringed by us if not for the WARF License, the royalty rate will be
+Added: tripled for the remaining term of the WARF License.
+Added: Under the Amended and Restated License and Development
+Added: Agreement with Mayo (the “Mayo Development Agreement”), we have agreed to pay Mayo a royalty equal to a single-digit percentage
+Added: of our product sales pursuant to the Mayo Development Agreement.
+Added: See “Note 4 – Commitments and Contingencies” included
+Added: in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report for more information
+Added: about the WARF License and the Mayo Development Agreement.
+Added: Our other cash requirements within the next twelve
+Added: months include accounts payable, accrued expenses, purchase commitments and other current liabilities.
+Added: Our other cash requirements greater
+Added: than twelve months from various contractual obligations and commitments include operating leases and contracted services.
+Added: Refer to “Note
+Added: 4 – Commitments and Contingencies” included in our condensed financial statements included in “Part 1, Item 1 –
+Added: Financial Statements” in this Report for further detail of our lease obligations and the timing of expected future payments.
+Added: services include agreements with third-party service providers for clinical research, product development, manufacturing, supplies, payroll
+Added: services, equipment maintenance services, and audits for periods up to fiscal 2023.
+Added: We expect to satisfy our short-term and long-term
+Added: obligations through cash on hand and, until we generate an adequate level of revenue from commercial sales to cover expenses, if ever,
+Added: from future equity and debt financings.
+Added: Liquidity Outlook
+Added: For a discussion of potential fee payments under
+Added: the Zimmer Development Agreement, see “Note 7 — Zimmer Development Agreement” included in our condensed financial statements
+Added: included in “Part 1, Item 1 – Financial Statements” in this Report.
+Added: The Company does not intend to deliver saleable
+Added: product to Zimmer unless and until it receives regulatory clearance to expand the use of its Evo sEEG Electrode technology for up to
+Added: 30 days, at which point the Company and Zimmer intend to commence negotiations regarding payments of applicable milestone payments described
+Added: therein, notwithstanding the deadlines for the Product Availability Date and the Acceptance of all Deliverables for SEEG Products.
+Added: has exclusive global rights to distribute our strip and grid cortical electrodes, depth electrodes and electrode cable assembly products.
+Added: Zimmer’s failure to timely develop or commercialize these products would have a material adverse effect on our business and operating
+Added: Further, our inability to agree with Zimmer on dates of completion for product development, regulatory clearance and commercialization
+Added: milestones on which various fee payments to the Company are based under the Zimmer Development Agreement could have a material adverse
+Added: impact on our financial and operating results.
+Added: At December 31, 2021, we had approximately $16.2
+Added: million in cash deposits.
+Added: Management has noted the existence of substantial doubt about our ability to continue as a going concern.
+Added: Additionally,
+Added: our independent registered public accounting firm and our former independent registered public accounting firm included explanatory paragraphs
+Added: in the reports on our financial statements as of and for the years ended September 30, 2021 and 2020, respectively, noting the existence
+Added: of substantial doubt about our ability to continue as a going concern.
+Added: Our existing cash may not be sufficient to fund our operating
expenses through at least twelve months from the date of this filing.
−Removed: While our future operating activities under the distribution and
−Removed: development agreement with Zimmer, Inc.
−Removed: coupled with our plans to raise capital or issue debt financing, may provide additional liquidity
−Removed: in the future, these actions are not solely within our control.
−Removed: If we are unable to raise additional funds, or if our anticipated operating
−Removed: results are not achieved, we believe planned expenditures may need to be reduced in order to extend the time period that existing resources
−Removed: can fund our operations.
−Removed: If we are unable to obtain the necessary capital, it may have a material adverse effect on our operations and
−Removed: the development of our technology, or we may have to cease operations altogether.
−Removed: have agreements with the Wisconsin Alumni Research Foundation (“WARF”) and the Mayo Foundation for Medical Education and
−Removed: Research (“Mayo”) that require us to make certain milestone and royalty payments.
−Removed: Medical Technologies Corporation
−Removed: January 22, 2020, we entered into an Amended and Restated License Agreement (the “WARF License”) with WARF, which amended
−Removed: and restated in full our prior license agreement with WARF, dated October 1, 2014 (the “Original WARF License”).
−Removed: WARF License, we have agreed to pay WARF a royalty equal to a single-digit percentage of our product sales pursuant to the WARF License,
−Removed: with a minimum annual royalty payment of $50,000 for 2020, $100,000 for 2021 and $150,000 for 2022 and each calendar year thereafter
−Removed: that the WARF License is in effect.
−Removed: The minimum annual royalty payment for calendar year 2020 in the amount of $50,000 was paid in January
−Removed: If we or any of our sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency
−Removed: of such contest and, if the contested patent is found to be valid and would be infringed by us if not for the WARF License, the royalty
−Removed: rate will be tripled for the remaining term of the WARF License.
−Removed: the Amended and Restated License and Development Agreement with Mayo (the “Mayo Development Agreement”), we have agreed to
−Removed: pay Mayo a royalty equal to a single-digit percentage of our product sales pursuant to the Mayo Development Agreement.
−Removed: Nothing further
−Removed: was due until we started selling our products.
−Removed: As of June 30, 2020, $3,894 in royalty payments were earned by Mayo given the commencement
−Removed: of commercial sales in fiscal year 2021.
−Removed: to the Company’s Annual Report on Form 10-K for the year ended September 30, 2020 with regard to:
−Removed: “Item 1—Business—WARF
−Removed: License,” “Business—Mayo Foundation for Medical Education and Research License and Development Agreement,” “Item
−Removed: 1A—Risk Factors—Risks Relating to Our Business—We depend on intellectual property licensed from WARF for our technology
−Removed: under development, and the termination of this license would harm our business” and “Item 1A—Risk Factors—We
−Removed: depend on our partnership with Mayo to license certain know how for the development and commercialization of our technology.”
−Removed: continue to fund operations, we will need to secure additional funding or take steps to reduce expenses.
−Removed: We may obtain additional financing
−Removed: in the future through the issuance of our common stock and securities convertible into our common stock, through other equity or debt
−Removed: financings or through collaborations or partnerships with other companies.
−Removed: We may not be able to raise additional capital on terms acceptable
−Removed: to us, or at all.
−Removed: Further, any failure to raise capital when needed could compromise our ability to execute on our business plan.
−Removed: development and commercialization of our cortical strip, grid electrode and depth electrode technology is subject to numerous uncertainties,
−Removed: and we have based these estimates on assumptions that may prove to be substantially different than we currently anticipate and could
−Removed: use our cash resources sooner than we expect.
−Removed: Additionally, the process of developing medical devices is costly, and the timing of progress
−Removed: in pre-clinical tests and clinical trials is uncertain.
−Removed: Our ability to successfully transition to profitability will be dependent upon
−Removed: achieving certain regulatory approval and then a level of product sales adequate to support our cost structure.
−Removed: We cannot assure you
−Removed: that we will ever be profitable or generate positive cash flow from operating activities.
−Removed: following is a summary of cash flows for each of the periods set forth below.
−Removed: nine Months Ended
−Removed: cash used in operating activities
+Added: To continue to fund operations, we will need to secure additional
+Added: funding through public or private equity or debt financings, through collaborations or partnerships with other companies or other sources.
+Added: We may not be able to raise additional capital on terms acceptable to us, or at all.
+Added: Any failure to raise capital when needed could compromise
+Added: our ability to execute on our business plan.
+Added: If we are unable to raise additional funds, or if our anticipated operating results are
+Added: not achieved, we believe planned expenditures may need to be reduced in order to extend the time period that existing resources can fund
+Added: our operations.
+Added: If we are unable to obtain the necessary capital, it may have a material adverse effect on our operations and the development
+Added: of our technology, or we may have to cease operations altogether.
+Added: The development and commercialization of our
+Added: cortical strip, grid electrode and depth electrode technology is subject to numerous uncertainties, and we could use our cash resources
+Added: sooner than we expect.
+Added: Additionally, the process of developing medical devices is costly, and the timing of progress in pre-clinical
+Added: tests and clinical trials is uncertain.
+Added: Our ability to successfully transition to profitability will be dependent upon achieving further
+Added: regulatory approvals and achieving a level of product sales adequate to support our cost structure.
+Added: We cannot assure you that we will
+Added: ever be profitable or generate positive cash flow from operating activities.
+Added: The following is a summary of cash flows for
+Added: each of the periods set forth below.
+Added: For the Three Months
+Added: Net cash used in operating activities
$ (2,679,136 )
$ (1,904,232 )
−Removed: used by investing activities
−Removed: cash provided by financing activities
−Removed: increase in cash
−Removed: cash used in operating activities
−Removed: cash used in operating activities was $6.6 million for the nine months ended June 30, 2021, which consisted of a net loss of $7.3 million
−Removed: partially offset principally by non-cash stock-based compensation, depreciation, amortization related to intangible assets, revaluation
−Removed: of convertible notes, operating lease expense and the forgiveness of the paycheck protection program loan, totaling approximately $1.5
−Removed: million in the aggregate.
+Added: Net cash used by investing activities
+Added: Net cash provided by financing activities
+Added: Net increase in cash
+Added: Net cash used in operating activities
+Added: Net cash used in operating activities was $2.7
+Added: million for the three months ended December 31, 2021, which consisted of a net loss of $2.8 million partially offset by non-cash stock-based
+Added: compensation, depreciation, amortization related to intangible assets and operating lease expense, totaling approximately $0.3 million
+Added: in the aggregate.
The net change in our net operating assets and liabilities associated with fluctuations in our operating activities
resulted in a cash use of $0.1 million.
−Removed: The change in operating assets and liabilities was primarily attributable to a decrease in accounts
−Removed: payable and accrued expenses attributed to the timing of payments coupled to a lesser extent with an increase in accounts receivable,
−Removed: inventory and prepaid and other assets.
−Removed: cash used in operating activities was $3.7 million for the nine months ended June 30, 2020, which consisted of a net loss of $13.1 million
−Removed: partially offset primarily by non-cash interest, stock-based compensation, depreciation, amortization related to intangible assets, operating
−Removed: lease expense, revaluation of convertible notes and loss on notes extinguishment, totaling approximately $9.8 million in the aggregate.
−Removed: The net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash
−Removed: use of approximately $0.5 million.
−Removed: The change in operating assets and liabilities was primarily attributable to a decrease in accounts
−Removed: payable and accrued expenses and by an increase in our prepaid expenses.
−Removed: Medical Technologies Corporation
−Removed: cash used by investing activities
−Removed: cash used by investing activities was $32,000 and $66,000 during the nine months ended June 30, 2021 and 2020, respectively, and consisted
−Removed: of outlays for furniture and equipment.
−Removed: cash provided by financing activities
−Removed: cash provided by financing activities was $11.6 million for the nine months ended June 30, 2021, which consisted primarily of net proceeds
−Removed: received from the 2021 Private Placement in the amount of $11.3 million.
−Removed: There were also exercises of stock options and warrants during
−Removed: the nine months ended June 30, 2021 resulting in additional cash proceeds of $0.3 million, offset in part by deferred offering costs
−Removed: cash provided by financing activities was $7.3 million for the nine months ended June 30, 2020, which consisted primarily of net proceeds
−Removed: received upon the issuance of the 2019 and 2020 Paulson Notes and the common stock offering totalling $7.2 million in the aggregate,
−Removed: and $0.1 million in proceeds received from the Paycheck Protection Program.
−Removed: Accounting Policies
−Removed: financial statements are prepared in accordance with U.S.
+Added: The net cash use stemming from the change in operating assets and liabilities was primarily attributable
+Added: to an increase in inventory purchases, net decrease in account payable and accrued expenses attributed to the timing of payments, partially
+Added: offset by a decrease in accounts receivable in connection with the Zimmer Development Agreement.
+Added: Net cash used in operating activities was $1.9
+Added: million for the three months ended December 31, 2020, which consisted of a net loss of $2.0 million partially offset by non-cash stock-based
+Added: compensation, depreciation, amortization related to intangible assets, revaluation of convertible notes and operating lease expense,
+Added: totaling approximately $0.3 million in the aggregate.
+Added: The net change in our net operating assets and liabilities associated with fluctuations
+Added: in our operating activities resulted in a cash use of $0.2 million.
+Added: The change in operating assets and liabilities was primarily attributable
+Added: to a net increase in accounts receivable in connection with the Zimmer Development Agreement and a decrease in accounts payable attributed
+Added: to the timing of payments.
+Added: Net cash used by investing activities
+Added: Net cash used by investing activities consisted
+Added: of outlays for furniture and equipment during the three months ended December 31, 2021.
+Added: There were no investing activities during the
+Added: three months ended December 31, 2020.
+Added: Net cash provided by financing activities
+Added: Net cash provided by financing activities was
+Added: $12.0 million for the three months ended December 31, 2021, which consisted of net proceeds from the October 2021 Underwritten Public
+Added: Net cash provided by financing activities was
+Added: $5.0 million for the three months ended December 31, 2020, which consisted primarily of proceeds received in advance of the 2021 Private
+Added: Critical Accounting Estimates
+Added: Our financial statements are prepared in accordance
generally accepted accounting principles.
−Removed: These accounting principles require
−Removed: us to make estimates and judgments that can affect the reported amounts of assets and liabilities as of the date of the financial statements
−Removed: as well as the reported amounts of revenue and expense during the periods presented.
−Removed: We believe that the estimates and judgments upon
−Removed: which we rely are reasonably based upon information available to us at the time that we make these estimates and judgments.
−Removed: To the extent
−Removed: that there are material differences between these estimates and actual results, our financial results will be affected.
−Removed: The accounting
−Removed: policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding
−Removed: and evaluating our reported financial results are described in Note 3 — “Summary of Significant Accounting Policies”
−Removed: to our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.
−Removed: the nine months ended June 30, 2021, we commenced commercial sales of the Strip/Grid Products and Electrode Cable Assembly Products.
−Removed: As a result, we added the following critical accounting policies below:
−Removed: from product sales are recognized when control of the promised goods or services is transferred to our customers, in an amount that reflects
−Removed: the consideration we expect to be entitled to in exchange for those goods or services.
−Removed: At the inception of each contract, performance
−Removed: obligations are identified and the total transaction price is allocated to the performance obligations.
−Removed: of Product Revenue
−Removed: of product revenue consists of the manufacturing and materials costs incurred by our third-party contract manufacturer in connection
−Removed: with our Strip/Grid Products and outside supplier materials costs in connection with the Electrode Cable Assembly Products.
−Removed: cost of product revenue includes royalty fees incurred in connection with our license agreements.
−Removed: Medical Technologies Corporation
−Removed: for Doubtful Accounts
−Removed: record a provision for doubtful accounts, when appropriate, based on historical experience and a detailed assessment of the collectability
−Removed: of our accounts receivable.
−Removed: In estimating the allowance for doubtful accounts, we consider, among other factors, the aging of the accounts
−Removed: receivable, our historical write-offs, the credit worthiness of each customer, and general economic conditions.
−Removed: Account balances are
−Removed: charged off against the allowance when we believe that it is probable that the receivable will not be recovered.
−Removed: Actual write-offs may
−Removed: be in excess of our estimated allowance.
−Removed: are stated at the lower of cost (using the first-in, first-out “FIFO” method) or net realizable value.
−Removed: We calculate inventory
−Removed: valuation adjustments for excess and obsolete inventory, when appropriate, based on current inventory levels, movement, expected useful
−Removed: lives, and estimated future demand of the products and spare parts.
−Removed: Our inventory is currently comprised of cEEG strip/grid and electrode
−Removed: cable assembly finished good products.
−Removed: The strip/ grid products are produced by a third-party contract manufacturer and the electrode
−Removed: cable assembly products are obtained from outside suppliers.
−Removed: were no additional material changes to our critical accounting policies or estimates disclosed in “Management’s Discussion
−Removed: and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended September
−Removed: Accounting Pronouncements
−Removed: to Note 3 — “Summary of Significant Accounting Policies” to our condensed financial statements included in “Part
−Removed: 1, Item 1 – Financial Statements” in this Report for a discussion of recently issued accounting pronouncements.
−Removed: Balance Sheet Arrangements
−Removed: Quantitative and Qualitative Disclosures About Market Risk
−Removed: applicable for smaller reporting companies.
+Added: These accounting principles require us to make estimates and judgments that can affect
+Added: the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue
+Added: and expense during the periods presented.
+Added: We believe that the estimates and judgments upon which we rely are reasonably based upon information
+Added: available to us at the time that we make these estimates and judgments.
+Added: To the extent that there are material differences between these
+Added: estimates and actual results, our financial results will be affected.
+Added: The accounting policies that reflect our more significant estimates
+Added: and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results
+Added: are described in Note 3 — “Summary of Significant Accounting Policies” to our condensed financial statements included
+Added: in “Part 1, Item 1 – Financial Statements” in this Report.
+Added: Of these policies, the following are considered
+Added: critical to an understanding of our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
+Added: in this Report as they require the application of the most subjective and the most complex judgments:
+Added: For discussion about the determination of collaborations
+Added: revenue, product revenue and cost of product revenue, see “Note 7 — Zimmer Development Agreement” included in our condensed
+Added: financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.
+Added: To date, we have not had,
+Added: nor expect to have in the future, significant variable consideration adjustments related to product revenue, such as chargebacks, sales
+Added: allowances and sales returns.
+Added: Stock-based Compensation
+Added: For discussions about the application of grant
+Added: date fair value associated with our stock-based compensation, see “Note 9 — Stock-Based Compensation” included in our
+Added: condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.
+Added: Income Tax Assets and Liabilities
+Added: Income tax assets and liabilities include income
+Added: tax valuation allowances.
+Added: For additional information, see “Note 11 — Income Taxes” included in our condensed financial
+Added: statements included in “Part 1, Item 1 – Financial Statements” in this Report and “Note 11 – Income Taxes”
+Added: in Part II, Item 8 “Financial Statements" of our Annual Report on Form 10-K for the year ended September 30, 2021.
+Added: Contingencies
+Added: We are subject to numerous contingencies arising
+Added: in the ordinary course of business, including legal contingencies.
+Added: For additional information, see “Note 4 — Commitments
+Added: and Contingencies” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
+Added: in this Report.
+Added: Recent Accounting Pronouncements
+Added: Refer to “Note 3— Summary of Significant
+Added: Accounting Policies” to our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
+Added: in this Report for a discussion of recently issued accounting pronouncements.
+Added: Quantitative and Qualitative Disclosures
+Added: About Market Risk
+Added: Not applicable for smaller reporting companies.
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.