−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
−Removed: CONDITION AND RESULTS OF OPERATIONS
+Added: MANAGEMENT’S DISCUSSION AND
+Added: ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
1 unchanged sentence
elsewhere in this Report.
−Removed: We are a medical technology
−Removed: company focused on the development and commercialization of thin film electrode technology for continuous electroencephalogram (“cEEG”)
−Removed: and stereoelectrocencephalography (“sEEG”), spinal cord stimulation, brain stimulation, drug delivery and ablation solutions
−Removed: for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries
−Removed: and other related neurological disorders.
−Removed: We are also developing the capability to use our sEEG electrode technology to deliver drugs
−Removed: or gene therapy while being able to record brain activity before, during, and after delivery.
−Removed: Additionally, we are investigating the potential
−Removed: applications of our technology associated with artificial intelligence.
−Removed: We have 510(k) clearance for three of our devices
−Removed: from the FDA, including:
−Removed: (i) our Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue for up to 30
−Removed: days, (ii) our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment
−Removed: for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, and (iii) our OneRF ablation
−Removed: system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
−Removed: Our other products are still
+Added: We are a medical technology company focused on
+Added: (i) diagnostic, ablation and deep brain stimulation technology for brain related conditions such as epilepsy and Parkinson’s disease;
+Added: (ii) ablation and stimulation for pain management throughout the body;
+Added: and (iii) drug delivery including diagnostic and stimulation capabilities.
+Added: We are developing and commercializing thin film
+Added: electrode technology for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography (“sEEG”),
+Added: spinal cord stimulation, brain stimulation, drug delivery and ablation solutions for patients suffering from epilepsy, trigeminal neuralgia,
+Added: Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other pain-related neurological
+Added: The Company is also developing the capability to use its sEEG electrode technology to deliver drugs or gene therapy while being
+Added: able to record activity before, during, and after delivery.
+Added: We have received 510(k) clearance for four of
+Added: our devices from the Food and Drug Administration (“FDA”), including:
+Added: (i) our Evo cortical electrode technology for recording,
+Added: monitoring, and stimulating brain tissue for up to 30 days (“Evo Cortical”), (ii) our Evo sEEG electrode technology for temporary
+Added: (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical
+Added: signals at the subsurface level of the brain (“Evo sEEG”), (iii) our OneRF ablation system for creation of radiofrequency
+Added: lesions in nervous tissue for functional neurosurgical procedures (“OneRF Ablation System”), (iv) our OneRF TN ablation system
+Added: for use in procedures to create radiofrequency (RF) lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical
+Added: procedures (“OneRF TN Ablation System”).
+Added: We have a distribution agreement with Zimmer, Inc.
+Added: (“Zimmer”) providing
+Added: Zimmer with a license to commercialize and distribute the Evo Cortical, Evo sEEG, and OneRF Ablation System in the brain.
+Added: a limited market release of the OneRF TN Ablation System in December 2025.
+Added: The Company’s other products and indications are still
under development.
−Removed: We distribute our cEEG strip/grid electrodes,
−Removed: cable assembly products and our OneRF Ablation System with Zimmer Biomet.
−Removed: We have incurred losses
−Removed: since inception.
−Removed: As of September 30, 2024, we had an accumulated deficit of $75.0 million, primarily as a result of expenses incurred
−Removed: in connection with our research and development, selling, general and administrative expenses associated with our operations and interest
−Removed: expense, fair value adjustments and loss on extinguishments related to our debt, offset in part by collaborations and product revenues.
−Removed: Prior to FDA clearance
−Removed: of certain of our products, our main sources of cash, cash equivalents and short-term investments were proceeds from the issuances of
−Removed: notes, common stock, warrants and unsecured loans.
+Added: We have largely incurred losses since inception.
+Added: As of September 30, 2025, we had an accumulated deficit of $78.6 million, primarily as a result of expenses incurred in connection with
+Added: our research and development, selling, general and administrative expenses associated with our operations and interest expense, fair value
+Added: adjustments and loss on extinguishments related to our debt, offset in part by license and product revenues.
+Added: Prior to FDA clearance of certain of our products,
+Added: our main sources of cash, cash equivalents and short-term investments were proceeds from the issuances of notes, common stock, warrants
+Added: and unsecured loans.
See “ Liquidity and Capital Resources—Capital Resources ” below.
−Removed: we have begun to generate revenue from the sale of products based on our cEEG and sEEG technology, and OneRF System, and through
−Removed: milestone and other payments from our current collaboration with Zimmer, we expect to continue to incur significant expenses and
−Removed: increasing operating and net losses for the foreseeable future until and unless we generate a higher level of revenue from commercial
−Removed: sales, and we will need to obtain substantial additional funding in connection with our continuing operations through public
−Removed: or private equity or debt financings, through collaborations or partnerships with other companies or other sources.
−Removed: We may be unable to raise
−Removed: additional funds when needed on favorable terms or at all.
−Removed: Our failure to raise such capital as and when needed would have a negative
−Removed: impact on our financial condition and our ability to develop and commercialize our cortical strip, grid electrode and depth electrode
−Removed: technology and future products and our ability to pursue our business strategy.
−Removed: See “Liquidity and Capital Resources—Liquidity
−Removed: Outlook” below.
+Added: While we have begun
+Added: to generate revenue from the sale of our Evo Cortical, Evo sEEG, OneRF Ablation System, and OneRF TN Ablation System, and through milestone
+Added: and other payments from our current collaboration and distribution arrangement with Zimmer, we expect to continue to incur significant
+Added: expenses and may incur increasing operating and net losses for the foreseeable future until we generate a higher level of revenue from
+Added: commercial sales.
+Added: NeuroOne Medical Technologies Corporation
Recent Developments
Corporate Updates
−Removed: OneRF Ablation System
−Removed: In March 2024, we announced a limited commercial
−Removed: launch of our OneRF ablation system.
−Removed: In October 2024, we amended and restated our Distribution Agreement with Zimmer to provide exclusive
−Removed: right and license to distribute also our OneRF Ablation System.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Nasdaq Notice
−Removed: Since May 28, 2024, the closing price of our common
−Removed: stock has been below $1.00.
−Removed: On July 11, 2024, we received a letter from the Listing Qualifications Department of the Nasdaq informing
−Removed: us that because the closing bid price for our common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company
−Removed: was not in compliance with the Minimum Bid Price Requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq
−Removed: Marketplace Rule 5550(a)(2).
−Removed: In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from
−Removed: July 11, 2024, or until January 7, 2025, to regain compliance with the Minimum Bid Price Requirement.
−Removed: If at any time before January 7,
−Removed: 2025, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading
−Removed: days (which number days may be extended by Nasdaq), Nasdaq will provide written notification that the Company has achieved compliance
−Removed: with the Minimum Bid Price Requirement, and the matter would be resolved.
−Removed: The Notice also disclosed that in the event we
−Removed: do not regain compliance with the Rule by January 7, 2025, we may be eligible for additional time.
−Removed: To qualify for additional time, we
−Removed: would be required to meet the applicable market value of publicly held shares requirement for continued listing and all other applicable
−Removed: standards for initial listing on The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide
−Removed: written notice of our intention to cure the deficiency during the second compliance period.
−Removed: If we meet these requirements, Nasdaq will
−Removed: inform us that it has been granted an additional 180 calendar days.
−Removed: However, if it appears to the Staff that we will not be able to cure
−Removed: the deficiency, or if we are otherwise not eligible, Nasdaq will provide notice that our securities will be subject to delisting.
−Removed: We intend to continue actively monitor the closing
−Removed: bid price for our common stock between now and January 7, 2025, and will consider available options to resolve the deficiency and regain
−Removed: compliance with the Minimum Bid Price Requirement.
−Removed: If we do not regain compliance within the allotted compliance period, including any
−Removed: extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting.
−Removed: We would then
−Removed: be entitled to appeal that determination to a Nasdaq hearings panel.
−Removed: There can be no assurance that we will regain compliance with the
−Removed: Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of 180 calendar days to regain compliance,
−Removed: or maintain compliance with the other Nasdaq listing requirements.
−Removed: Debt Facility Agreement
−Removed: On August 2, 2024, we entered into a loan and
−Removed: security agreement with Growth Opportunity Funding, LLC, as the Lender, which provides for a delayed draw term loan Debt Facility in an
−Removed: aggregate principal amount not to exceed $3.0 million.
−Removed: We are permitted to borrow loans under the Debt Facility from time to time, for
−Removed: general corporate purposes and subject to certain specified conditions, until the earliest of:
−Removed: (i) November 30, 2024, (ii) the occurrence
−Removed: of any monetization or change in control, or (iii) at the Lender’s option, upon the occurrence and during the continuance of an
−Removed: event of default under the Debt Facility Agreement.
−Removed: The Loan(s), upon issuance, will be secured by substantially all of our assets, subject
−Removed: to certain exceptions set forth in the Debt Facility Agreement, and will be subject to covenants.
−Removed: On November 7, 2024, we mutually agreed
−Removed: with the Lender to terminate the loan facility.
−Removed: On August 2, 2024, we issued 100,000 Lender Warrants
−Removed: to Lender to purchase shares of the Company’s common stock at exercise price of $0.66 per share.
−Removed: The warrants are immediately exercisable
−Removed: and expire on August 2, 2029.
−Removed: 2024 Private Placement
−Removed: On August 1, 2024, we entered into a Securities
−Removed: Purchase Agreement which closed on August 2, 2024, with certain Purchasers, pursuant to which we, in the Private Placement, agreed to
−Removed: issue and sell an aggregate of (i) 2,944,446 shares of the our common stock, and (ii) warrants to purchase an aggregate of 2,208,338 shares
−Removed: of common stock at a purchase price of $0.90 per unit, consisting of one share and a PIPE warrant to purchase 0.75 shares of common stock,
−Removed: resulting in total gross proceeds of approximately $2.65 million before deducting estimated expenses.
−Removed: In connection with the 2024 Private
−Removed: Placement, we filed a registration statement with the U.S.
−Removed: Securities and Exchange Commission (“SEC”) covering the resale
−Removed: of the securities issued in the 2024 Private Placement.
−Removed: One of the Purchasers in the 2024 Private Placement included Paul Buckman, a director
−Removed: on the Company’s Board of Directors.
−Removed: NeuroOne Medical Technologies Corporation
+Added: 510(k) Clearance for Trigeminal Facial Pain
+Added: On August 15, 2025 we received FDA 510(k) clearance
+Added: to market its OneRF® Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for the treatment of
+Added: pain, or for lesioning nerve tissue for functional neurosurgical procedures.
+Added: 2025 Financing
+Added: 4, 2025, we entered into an underwriting agreement with Ladenburg Thalmann & Co.
+Added: as underwriter ( “Ladenburg”), relating
+Added: to the issuance and sale of 16,000,000 shares of the Company’s common stock, at a price to the public of $0.50 per share (the “April
+Added: 2025 Financing”).
+Added: In addition, under the terms of the underwriting agreement, we granted Ladenburg an option, exercisable for 45
+Added: days, to purchase up to an additional 2,400,000 shares of common stock on the same terms as the offering, which was exercised in full.
+Added: Net proceeds to the Company were approximately $8.2 million.
+Added: Zimmer Amended and Restated Distribution Agreement
+Added: On October 25, 2024, we entered into the Zimmer
+Added: Amended and Restated Distribution Agreement (the “Amendment”) with Zimmer, Inc.
+Added: (“Zimmer”) pursuant to which we
+Added: granted Zimmer the exclusive right and license to distribute our OneRF Ablation System for an upfront payment of $3.0 million, with eligibility
+Added: for an additional $1.0 million payment from Zimmer upon achievement of certain specified net sales milestones.
+Added: We previously entered into an Exclusive Development
+Added: and Distribution Agreement dated July 20, 2020 with Zimmer, related to the Evo Cortical and Evo sEEG products, which was subsequently
+Added: amended pursuant to the terms and conditions of a letter agreement dated January 6, 2021, a Second Amendment to Exclusive Development
+Added: and Distribution Agreement dated June 28, 2022, and a Third Amendment to Exclusive Development and Distribution Agreement dated August
+Added: 2, 2022 (collectively, the “EDDA”).The EDDAs executed prior to the Amendment granted Zimmer exclusive global rights to distribute
+Added: the Evo Cortical and Evo sEEG products.
+Added: In addition, under the prior EDDAs, we agreed to collaborate with respect to development activities
+Added: through a joint development committee composed of an equal number of representatives of Zimmer and the Company.
+Added: Under the Amendment, Zimmer paid us $3.0 million
+Added: for an exclusive RF Distribution License (the “RF Distribution License” and “License”) for commercialization of
+Added: the OneRF Ablation System in the brain.
+Added: In addition, we are eligible to receive a future milestone payment of $1.0 million upon reaching
+Added: a one-time sales volume threshold.
+Added: We do not anticipate receiving this milestone payment.
+Added: The revised term under the Amendment (the “Term”) began
+Added: on the effective date and will remain in effect until October 31, 2034.
+Added: Upon the expiration of the Term, it may be renewed upon the mutual
+Added: written of the Parties.
+Added: The Zimmer Amended and Restated Exclusive Development and Distribution Agreement may be terminated before the
+Added: expiration of the Term only by the Parties in accordance with certain terms under the Amendment.
+Added: In addition, the license rights granted
+Added: to Zimmer under this Amendment shall be exclusive (i) from the original effective date until September 30, 2032 for the Evo Cortical and
+Added: Evo sEEG products;
+Added: and (ii) from the effective date until October 31, 2034 for the OneRF Ablation System.
Global Economic Conditions
9 unchanged sentences
to decline, our future cost of equity or debt capital and access to the capital markets could be adversely affected.
+Added: We have experienced
+Added: minor price increases from our suppliers related to tariffs on imported goods, and may experience additional price increases.
+Added: NeuroOne Medical Technologies Corporation
Our operating results could be materially impacted
7 unchanged sentences
Our product revenue was derived from the sale
−Removed: of our Strip/Grid Products, the sEEG Products and the Electrode Cable Assembly Products based on Evo cortical electrode technology and
−Removed: the OneRF Products, which are products based on our OneRF Ablation System.
−Removed: We anticipate that we will generate additional revenue from
−Removed: the sale of products based on Evo cortical electrode technology and our OneRF Ablation System.
−Removed: In November 2019, we received FDA 510(k) clearance
−Removed: for our cortical electrode for temporary (less than 30 days) recording, monitoring, and stimulation on the surface of the brain.
−Removed: 2022, we received FDA 510(k) clearance for our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring,
−Removed: and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
−Removed: December 2023, we received FDA 510(k) clearance for our OneRF Ablation System for creation of radiofrequency lesions in nervous tissue
−Removed: for functional neurosurgical procedure.
+Added: of our Evo Cortical, Evo sEEG, and OneRF Ablation System, which have each received FDA 510(k) clearance.
Product Gross Profit
2 unchanged sentences
Our cost of product revenue consists of the manufacturing and materials costs incurred by our third-party
−Removed: contract manufacturer in connection with our Strip/Grid Products, sEEG Products, OneRF Products and outside supplier materials costs of
−Removed: producing the Electrode Cable Assembly Products.
−Removed: In addition, cost of product revenue includes royalty fees incurred in connection with
−Removed: our license agreements.
−Removed: Collaborations Revenue
−Removed: On July 20, 2020, we entered into an exclusive
−Removed: development and distribution agreement (the “Zimmer Distribution Agreement”) with Zimmer, pursuant to which we granted Zimmer
−Removed: exclusive global rights to distribute the Strip/Grid Products and Electrode Cable Assembly Products.
−Removed: Additionally, we granted Zimmer the
−Removed: exclusive right and license to distribute certain sEEG Products developed by the Company.
−Removed: The OneRF ablation system is not covered by
−Removed: the Zimmer Distribution Agreement.
−Removed: The parties agreed to collaborate with respect to development activities under the Zimmer Distribution
−Removed: Agreement through a joint development committee composed of an equal number of representatives of Zimmer and the Company.
−Removed: Under the terms of the Zimmer Distribution Agreement,
−Removed: we are responsible for all costs and expenses related to developing the Products (as defined therein), and Zimmer is responsible for all
−Removed: costs and expenses related to the commercialization of the Products.
−Removed: In addition to the Zimmer Distribution Agreement, Zimmer and the
−Removed: Company have entered into a MS Agreement and a Quality Agreement with respect to the manufacturing and supply of the Products.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Pursuant to the Zimmer Distribution Agreement,
−Removed: Zimmer made an upfront initial exclusivity fee payment of $2.0 million (the “Initial Exclusivity Fee”) to the Company
−Removed: in fiscal year 2020.
−Removed: In addition, on August 2, 2022, we entered into a Third Amendment to the Zimmer Distribution Agreement (the “Zimmer
−Removed: Amendment”) with Zimmer.
−Removed: Pursuant to the terms and conditions of the Zimmer Amendment, Zimmer made a $3.5 million payment to
−Removed: us in August 2022.
−Removed: In consideration of the mutual covenants and agreements contained in the Zimmer Distribution Agreement, certain fee
−Removed: and milestone payment provisions in the Zimmer Distribution Agreement were replaced with the following below:
−Removed: ● $1.5 million for the sEEG exclusivity maintenance fee;
−Removed: $2.0 million for satisfaction of each of the milestone events related to the design of sEEG Products set forth in the Zimmer Distribution Agreement, even though the satisfaction was after the deadlines originally identified.
−Removed: In addition, in connection with the Zimmer Amendment,
−Removed: we issued to Zimmer a warrant to purchase common stock (the “2022 Zimmer Warrant”).
−Removed: The 2022 Zimmer Warrant is exercisable
−Removed: for up to an aggregate of 350,000 shares of our common stock.
−Removed: The 2022 Zimmer Warrant has an exercise price of $3.00 per
−Removed: share, is exercisable commencing six months from the issuance date, and will expire on August 2, 2027.
−Removed: The Zimmer Distribution Agreement and Zimmer Amendment
−Removed: were accounted for under the provisions of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with
−Removed: Customers (“ASC 606”) .
−Removed: In accordance with the provisions under ASC 606, we identified five performance obligations
−Removed: under the Zimmer Distribution Agreement and Zimmer Amendment:
−Removed: (1) our obligation to grant Zimmer access to our intellectual property;
−Removed: (2) completion of sEEG Product development;
−Removed: (3) completion of Strip/Grid Product development;
−Removed: (4) the provision of sEEG exclusivity maintenance;
−Removed: and (5) sEEG design modifications as requested by Zimmer.
−Removed: All performance obligations under the Zimmer Distribution Agreement and Zimmer
−Removed: Amendment were met as of December 31, 2022.
−Removed: In October 2022, we received 510(k) clearance
−Removed: from the FDA for our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment
−Removed: for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
−Removed: Accordingly, we recognized
−Removed: revenue in the amount of $1.5 million during the year ended September 30, 2023 related to the completion of the sEEG exclusivity maintenance
−Removed: There was no collaboration revenue during the year ended September 30, 2024.
−Removed: In October 2024, we amended and restated our development
−Removed: and distribution agreement with Zimmer to grant exclusive right and license to distribute also our OneRF Ablation System for an upfront
−Removed: fee of $3.0 million dollars and up to an additional $1.0 million dollars upon achievement of certain net sales milestone by Zimmer.
−Removed: The Zimmer Amended and Restated Distribution Agreement
−Removed: will expire on September 30, 2034 (the “Zimmer Term”), unless terminated earlier pursuant to its terms.
−Removed: Either party may terminate
−Removed: the Zimmer Amended and Restated Distribution Agreement (x) with written notice for the other party’s material breach following a
−Removed: cure period or (y) if the other party becomes subject to certain insolvency proceedings.
−Removed: In addition, Zimmer may terminate the Zimmer
−Removed: Amended and Restated Distribution Agreement for any reason with 90 days’ written notice, and the Company may terminate the Zimmer
−Removed: Amended and Restated Distribution Agreement if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors
−Removed: of the Company.
−Removed: The license rights granted to Zimmer under the Zimmer Amended and Restated Distribution Agreement shall be exclusive from
−Removed: the effective date of the Zimmer Amendment until the end of the Zimmer Term.
−Removed: All payments attributed to the Initial Exclusivity
−Removed: Fee, the sEEG exclusivity maintenance fee and sEEG design milestone payment are non-refundable.
−Removed: The achievement of the level of sales required
−Removed: to earn royalty payments from Zimmer is uncertain.
−Removed: For further discussion about the determination
−Removed: of collaborations revenue, product revenue and cost of product revenue, and for a discussion of milestones and royalty payments under
−Removed: the Zimmer Distribution Agreement, see “—Liquidity and Capital Resources—Liquidity Outlook” below and see
−Removed: “Note 7 — Zimmer Distribution Agreement” included in our financial statements
−Removed: included in Item 8 — Financial Statements and Supplementary Data” in this Report.
−Removed: NeuroOne Medical Technologies Corporation
+Added: contract manufacturers in connection with our Evo Cortical, Evo sEEG, and OneRF Ablation Systems, and outside supplier costs of producing
+Added: our electrode cable assembly products.
+Added: In addition, the cost of product revenue includes royalty fees incurred in connection with our
+Added: license agreements as well as valuation adjustments for excess or obsolete inventory.
+Added: License Revenue
+Added: The Company determined that the RF Distribution License granted
+Added: under the Zimmer Amended and Restated Distribution Agreement represented functional intellectual property given Zimmer’s access
+Added: to the underlying intellectual property associated with the OneRF Ablation System.
+Added: As such, the revenue related to the license was recognized
+Added: at the point in time in which the license/know-how was delivered to Zimmer which occurred in October 2024.
+Added: Revenue recognized under
+Added: the Amendment during the year ended September 30, 2025 was $3.0 million.
+Added: For further discussion about the determination of license
+Added: revenue, product revenue and cost of product revenue, and for a discussion of milestones and royalty payments under the Zimmer Amended
+Added: and Restated Distribution Agreement, see “—Liquidity and Capital Resources—Liquidity Outlook” below and see “Note
+Added: 7 — Zimmer Distribution Agreement and Other Product Revenue” included in our financial statements included in Item 8
+Added: — Financial Statements and Supplementary Data” in this Report.
Selling, General and Administrative
4 unchanged sentences
costs, professional fees for consultants assisting with financial and administrative matters, and sales and marketing in connection with
−Removed: the commercial sale of cEEG strip/grid, sEEG depth electrode, OneRF ablation system and electrode cable assembly products.
−Removed: We anticipate
−Removed: that our selling, general and administrative expenses will increase in the future to support our continued research and development activities,
−Removed: further commercialization of our cortical strip and grid technology, ablation system and our depth electrode technology, and the increased
−Removed: costs of operating as a public company.
−Removed: These increases will include increased costs related to the hiring of additional personnel and
−Removed: fees for legal and professional services, as well as other public company related costs.
+Added: the commercial sale of our Evo Cortical, Evo sEEG, and OneRF Ablation Systems.
+Added: We anticipate that our selling, general and administrative
+Added: expenses will increase in the future to support our continued research and development activities, further commercialization of our technology,
+Added: and the increased costs of operating as a public company.
Research and Development
2 unchanged sentences
Research and development expenses include compensation
−Removed: and benefits for research and development employees including stock-based compensation, overhead expenses, cost of laboratory supplies,
−Removed: clinical trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to consultants and other
−Removed: outside expenses.
−Removed: Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted
−Removed: work is performed.
+Added: and benefits for research and development employees including stock-based compensation, overhead expenses, laboratory supplies, clinical
+Added: trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to consultants and other outside
+Added: Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work
+Added: is performed.
+Added: NeuroOne Medical Technologies Corporation
Fair Value Change in Warrant Liability
−Removed: The net change in fair value line item is attributed
−Removed: to the warrant liability while outstanding.
+Added: The net change in the fair value line item is
+Added: attributed to the warrant liability while outstanding.
Financing Costs
Financing costs consists of the amortization of
−Removed: the deferred issuance costs associated with the debt facility (as described further below) and issuance costs attributed to the warrants
−Removed: issued in connection with the 2024 Private Placement (as described further below).
−Removed: Other Income, net
−Removed: Other income, net primarily consists of interest
−Removed: income related to our cash, cash equivalents, investment income or loss from short-term investments, while outstanding, and other income
−Removed: or expense outside of normal operating activity relating to legal settlements, sales of non-commercial supplies and other items as applicable.
+Added: the deferred issuance costs and other lending and issuance costs in connection with the debt facility and at-the market offering facility
+Added: (both described below).
+Added: Other income primarily consists of interest income
+Added: related to our cash and cash equivalents,
Results of Operations
15 unchanged sentences
(11,887,209 )
−Removed: (11,955,250 )
Fair value change in warrant liability
3 unchanged sentences
(12,318,110 )
−Removed: (11,859,491 )
Provision for income taxes
1 unchanged sentence
$ (12,318,110 )
−Removed: NeuroOne Medical Technologies Corporation
Product Revenue and Product Gross Profit
3 unchanged sentences
$3.5 million during the year ended September 30, 2024 with a gross profit and gross profit percentage of $1.1 million and 31.3%, respectively.
−Removed: The increase in gross profit percentage during the current period was largely due to the higher sales volume that exceeded fixed royalty
−Removed: and overhead period costs and due to slightly lower overall material supply costs.
−Removed: Product revenue consisted of Strip/Grid Products, sEEG
−Removed: Products, OneRF Products and Electrode Cable Assembly Products sales.
−Removed: Cost of product revenue consisted of the manufacturing and materials
−Removed: costs incurred by our third-party contract manufacturer in connection with our Strip/Grid Products, sEEG Products and OneRF Products,
−Removed: and outside supplier materials costs in connection with the Electrode Cable Assembly Products.
+Added: The increase in gross profit percentage during the current period was largely due to the higher margin OneRF Ablation System being sold
+Added: in the current period under the Amendment with Zimmer.
+Added: Product revenue consisted primarily of sales of the OneRF Ablation System to Zimmer
+Added: during the year ended September 30, 2025 while revenue consisted of Evo Cortical, Evo sEEG, and OneRF Ablation System sales during the
+Added: prior year period.
+Added: The cost of product revenue consisted of the manufacturing and materials costs incurred by our third-party contract
+Added: manufacturers in connection with our Evo Cortical, Evo sEEG, and OneRF Ablation System.
In addition, cost of product revenue included
−Removed: royalty fees incurred of approximately $157,000 in connection with our license agreements during each of the years ended September 30,
−Removed: 2024 and 2023.
+Added: royalty fees incurred of approximately $150,000 and $157,000 in connection with our license agreements during the years ended September
+Added: 30, 2025 and 2024, respectively.
+Added: NeuroOne Medical Technologies Corporation
Collaborations Revenue
−Removed: There was no collaborations revenue during the
−Removed: year ended September 30, 2024.
−Removed: Collaborations revenue was approximately $1.5 million during the year ended September 30, 2023.
−Removed: during the prior year period was derived from the Zimmer Distribution Agreement in connection with the completion of the sEEG maintenance
−Removed: fee obligation as a result of securing FDA approval.
+Added: License revenue was $3.0 million for the year ended September 30, 2025
+Added: which related to the distribution license granted to Zimmer for the OneRF Ablation System in October 2024.
+Added: No license revenue was generated
+Added: from the Zimmer Amended and Restated Development Agreement during the year ended September 30, 2024.
Selling, General and Administrative Expenses
1 unchanged sentence
$7.4 million and $7.9 million for the years ended September 30, 2025 and 2024, respectively.
−Removed: The $1.0 increase period over period was
−Removed: primarily due to an increase in payroll related costs of approximately $0.4 million, stock-based compensation of $0.2 million, professional
−Removed: and board fees of $0.3 million and marketing and sales costs of $0.2 million, offset slightly by a reduction in general operating costs
−Removed: of $0.1 million on a net basis.
+Added: The $0.5 million decrease period over period
+Added: was primarily due to a decrease in both legal fees in the amount of $0.4 million and investor relations related expense of $0.6 million,
+Added: offset in part by increases in payroll related costs of approximately $0.1 million, non-legal professional fees of $0.2 million, marketing
+Added: and sales costs of $0.1 million and other operating cost increases of $0.1 million on a net basis.
Research and Development Expenses
2 unchanged sentences
The $0.1 million decrease
−Removed: period over period was attributed to the net reduction in development activities associated with our sEEG Products, Strip/Grid Products
−Removed: and OneRF Products given the commercialization of these products.
−Removed: Activity associated with new technology development partially offset
−Removed: the overall net decrease in research and development costs during the current period.
+Added: period over period was attributed to the net reduction in development activities associated with our Evo Cortical, Evo sEEG, and OneRF
+Added: Ablation System, given the commercialization of these products.
+Added: Activity associated with new technology development largely offset the
+Added: overall net decrease in research and development costs during the current period.
Development activities primarily included salary-related
−Removed: expenses and costs related to consulting services, materials and supplies.
+Added: expenses and costs related to consulting services, testing, materials and supplies.
Fair Value Change in Warrant Liability
The net change in fair value of the warrant liability
−Removed: during the year ended September 30, 2024 was $0.3 million.
+Added: during the year ended September 30, 2025 resulted in a $0.8 million benefit compared to an expense of $0.3 million during the year ended
+Added: September 30, 2024.
The change was due primarily to fluctuations in our common stock fair value.
−Removed: There were no warrants outstanding during the year ended September 30, 2023 that were measured on a fair value basis.
Financing Costs
Financing costs during the year ended September
−Removed: 30, 2024 consisted of the amortization of the deferred issuance costs associated with the debt facility (described further below) in the
−Removed: amount of $0.1 million and issuance costs attributed to the warrants issued in connection with the 2024 Private Placement (described further
−Removed: below) in the amount of $0.1 million.
−Removed: We did not incur any financing costs during the year ended September 30, 2023.
−Removed: NeuroOne Medical Technologies Corporation
+Added: 30, 2025 of $0.3 million consisted of the amortization of the deferred issuance costs associated with the debt facility (described further
+Added: below) in the amount of $0.2 million and additional legal and loan facility termination costs of $0.1 million upon the termination of
+Added: the debt facility in November 2024.
+Added: In addition, $9,000 in legal fees were incurred in connection with the at-the market offering program
+Added: (described further below).
+Added: Financing costs during the year ended September
+Added: 30, 2024 of $0.2 million consisted of the amortization of the deferred issuance costs associated with the debt facility (described further
+Added: below) in the amount of $0.1 million and issuance costs attributed to the warrants issued in connection with the 2024 Private Placement
+Added: (described further below) in the amount of $0.1 million.
Other Income, net
Other income, net during the year ended September
−Removed: 30, 2024 consisted principally of interest income attributed to our cash and cash equivalents.
−Removed: Other income, net during the year ended September
−Removed: 30, 2023 related to interest income attributed to our cash, cash equivalents and short-term investments in the amount of $0.2 million,
−Removed: while outstanding, which was partially offset by an exploit loss of $94,000 and a loss on disposal of equipment in the amount of $32,000.
+Added: 30, 2025 and 2024 consisted principally of interest income attributed to our cash and cash equivalents.
Liquidity and Capital Resources
1 unchanged sentence
of liquidity consisted of cash and cash equivalents in the aggregate of approximately $6.6 million.
−Removed: While we began to generate revenue
−Removed: in fiscal year 2021 from commercial sales and through milestone and other payments under our collaboration with Zimmer, we expect to continue
−Removed: to incur significant expenses and increasing operating and net losses for the foreseeable future until and unless we generate an adequate
−Removed: level of revenue from commercial sales to cover expenses.
−Removed: Our most significant cash requirements relate to the funding of our ongoing
−Removed: product development and commercialization operations.
−Removed: Our additional material cash needs include commitments under operating leases, royalty
−Removed: obligations under our intellectual property licenses with the Wisconsin Alumni Research Foundation and the Mayo Foundation for Medical
−Removed: Education and Research as well as other administrative services.
−Removed: See “Funding Requirements” below for more information.
−Removed: anticipate that our expenses will increase substantially as we continue to develop and commercialize our electrode technology and pursue
−Removed: pre-clinical and clinical trials, seek regulatory approvals, manufacture products, market and distribute our OneRF Products, hire additional
−Removed: staff, add operational, financial and management systems and continue to operate as a public company.
−Removed: On August 2, 2024, we closed the
−Removed: 2024 Private Placement, a private placement of shares of common stock and warrants for total gross proceeds of approximately $2.65 million,
−Removed: and entered into the Debt Facility, a delayed draw term debt facility in an aggregate principal amount not to exceed $3.0 million.
+Added: NeuroOne Medical Technologies Corporation
Capital Resources
−Removed: Our sources of cash, cash equivalents and short-term
−Removed: investments to date have been limited to collaboration and product revenues, along with proceeds from the issuances of notes with warrants,
−Removed: common stock with and without warrants and unsecured loans with the terms of our more recent financings described below.
+Added: Our sources of cash and cash equivalents to date
+Added: have been limited to license, collaboration and product revenues, along with proceeds from the issuances of notes with warrants, common
+Added: stock with and without warrants and unsecured loans with the terms of our more recent financings described below.
+Added: 2025 Financing
+Added: 4, 2025, we entered into an underwriting agreement with Ladenburg, relating to the issuance and sale of 16,000,000 shares of our common
+Added: stock, at a price to the public of $0.50.
+Added: In addition, under the terms of the underwriting agreement, we granted Ladenburg an option,
+Added: exercisable for 45 days, to purchase up to an additional 2,400,000 shares of common stock on the same terms as the offering, which was
+Added: exercised in full.
+Added: Issuance costs in connection with the April 2025 Financing amounted to approximately $1.0 million which included a
+Added: 7.0% commission to the Underwriter and legal and other expenses in the amount of $0.3 million.
+Added: The Company received approximately $8.2
+Added: million in net proceeds.
August 2024 Private Placement
−Removed: On August 1, 2024,
−Removed: we entered into a Securities Purchase Agreement with certain Purchasers, pursuant to which we, in a private placement,
−Removed: agreed to issue and sell an aggregate of (i) 2,944,446 shares of our Company’s common stock (the “Shares”), par value
−Removed: $0.001 per share and (ii) warrants to purchase an aggregate of 2,208,333 shares of common stock (the “PIPE Warrants”)
−Removed: at a purchase price of $0.90 per unit, consisting of one share and a PIPE Warrant to purchase 0.75 shares of common stock, resulting
−Removed: in total gross proceeds of approximately $2.65 million before deducting estimated expenses.
−Removed: The 2024 Private Placement closed on
−Removed: August 2, 2024.
−Removed: Issuance costs attributed to the 2024 Private Placement amounted to $0.2 million.
−Removed: The PIPE Warrants are
−Removed: exercisable beginning on the date of issuance, have an exercise price of $1.19 per share, subject to adjustment, and will expire on the
−Removed: third anniversary of the date of issuance .
−Removed: connection with the 2024 Private Placement, we agreed to file a registration statement with the SEC covering the resale of the Shares
−Removed: and the shares of common stock issuable upon exercise of the PIPE Warrants which became effective on September 13, 2024.
−Removed: NeuroOne Medical Technologies Corporation
+Added: On August 1, 2024, we entered into a Securities
+Added: Purchase Agreement with certain purchasers, pursuant to which we, in a private placement, agreed to issue and sell an aggregate of
+Added: (i) 2,944,446 shares of our Company’s common stock (the “Shares”), par value $0.001 per share and (ii) warrants to purchase
+Added: an aggregate of 2,208,338 shares of common stock (the “PIPE Warrants”) at a purchase price of $0.90 per unit, consisting of
+Added: one share and a PIPE Warrant to purchase 0.75 shares of common stock, resulting in total gross proceeds of approximately $2.65 million
+Added: before deducting expenses.
+Added: The 2024 Private Placement closed on August 2, 2024.
+Added: Issuance costs attributed to the 2024 Private Placement
+Added: amounted to $0.2 million.
+Added: The PIPE Warrants are exercisable beginning on
+Added: the date of issuance and had an initial exercise price of $1.19 per share, subject to adjustment.
+Added: In April 2025, the exercise price was
+Added: reset to $0.465 upon the close of the April 2025 Financing for all of the PIPE Warrants, except for the PIPE Warrants to purchase 20,834
+Added: shares of common stock issued to a director on our Board of Directors for which the exercise price was reset to $0.876 per share.
+Added: PIPE Warrants will expire on the third anniversary of the date of issuance.
+Added: In connection with the 2024 Private Placement,
+Added: we agreed to file a registration statement with the SEC covering the resale of the Shares and the shares of common stock issuable upon
+Added: exercise of the PIPE Warrants which became effective on September 13, 2024.
At-The-Market Offering
1 unchanged sentence
on Demand TM Sales Agreement (“Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”)
−Removed: to create an at-the-market offering program (“ATM”) under which we may offer and sell shares having an aggregate offering
+Added: to create an at-the-market offering program (“ATM Program”) under which we may offer and sell shares having an aggregate offering
price of up to $14.5 million.
8 unchanged sentences
including the shares of common stock previously sold.
−Removed: Through September 30, 2024, we have issued 5,188,590 shares of common stock under
−Removed: the ATM for gross proceeds in the amount of $7.6 million.
−Removed: We incurred issuance costs in connection with the ATM in the amount of $0.5
−Removed: million through September 30, 2024 of which $41,000 was reflected as a deferred cost on our balance sheet.
−Removed: On August 16, 2024, we increased
−Removed: the amount of common stock that can be sold pursuant to the Sales Agreement by $3.0 million.
+Added: On August 16, 2024, we increased the amount of common stock that can be sold pursuant
+Added: to the Sales Agreement by $3.0 million.
+Added: On April 3, 2025, we decreased the amount of common stock that can be sold pursuant to the Sales
+Added: Agreement to zero.
+Added: On August 15, 2025, we increased the amount of common stock that can be sold pursuant to the Sales Agreement to $6,750,000.
+Added: Through September 30, 2025, we have issued 5,544,489 shares of common stock under the ATM Program for gross proceeds in the amount of
+Added: $8.0 million.
+Added: We incurred issuance costs in connection with the ATM Program in the amount of $0.6 million through September 30, 2025.
+Added: NeuroOne Medical Technologies Corporation
Debt Facility Financing
5 unchanged sentences
(i) November 30, 2024, (ii) the occurrence of any
−Removed: Monetization Event (as defined below) or Change of Control (as defined in the Debt Facility Agreement), or (iii) at the Lender’s
−Removed: option, upon the occurrence and during the continuance of an event of default under the Debt Facility Agreement.
−Removed: On November 7, 2024,
−Removed: the Company terminated the Debt Facility Agreement and no amounts were drawn under the Debt Facility Agreement.
−Removed: The Loans would have matured on February 2,
−Removed: 2026 if issued.
−Removed: The rate of interest on any outstanding principal amount would have been 10% per annum, payable monthly in arrears and
−Removed: at the maturity date.
−Removed: As of the closing date of the Debt Facility Agreement, no amounts were drawn by the Company thereunder.
−Removed: costs incurred in connection with the Debt Facility Agreement amounted to $0.3 million inclusive of the standby fee of $0.1 million to
−Removed: 2, 2024, we issued to the Lender a warrant exercisable for five years for 100,000 shares of our common stock at an exercise price
−Removed: of $0.66 per share, subject to adjustment (the “Closing Date Debt Facility Warrant”).
−Removed: At the time of any borrowing of Loans,
−Removed: we would have been required to issue to the Lender additional warrants exercisable for five years for 50,000 shares of common stock (for
−Removed: each $500,000 of Loans borrowed) at the same per share exercise price as the Closing Date Debt Facility Warrant (the “Additional
−Removed: Debt Facility Warrants”, and together with the Closing Date Debt Facility Warrant, the “Debt Facility Warrants”).
−Removed: We were permitted to
−Removed: voluntarily prepay the outstanding Loans at any time, without premium or penalty, upon five business days’ prior written notice
−Removed: to the Lender.
−Removed: We were required to prepay outstanding Loans upon the occurrence of (i) any Change of Control or (ii) certain other events
−Removed: as more fully described in the Debt Facility Agreement, but in any event including any capital raise or other transaction pursuant to
−Removed: which we received cumulative cash proceeds in excess of $5.0 million in the aggregate (each such event in this prong (ii), a “Monetization
−Removed: Our obligations under the Debt Facility Agreement were secured by a first-priority security interest in substantially all
−Removed: assets of the Company, subject to certain exceptions set forth in the Debt Facility Agreement.
−Removed: The Debt Facility Agreement
−Removed: included other customary representations and warranties, conditions, affirmative and negative covenants, and events of default.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: July 2023 Public Offering
−Removed: On July 24, 2023, we entered into an underwriting
−Removed: agreement with The Benchmark Company, LLC, as underwriter (“Benchmark”), relating to the issuance and sale of 5,250,000 shares
−Removed: of our common stock, par value $0.001 per share, at a price to the public of $1.00 per share (the “July 2023 Public Offering”).
−Removed: In addition, under the terms of the July 2023 Public Offering, we granted Benchmark an option, exercisable for 30 days, to purchase up
−Removed: to an additional 787,500 shares of common stock on the same terms (“the Overallotment Option”).
−Removed: The July 2023 Public Offering
−Removed: closed on July 27, 2023, and we completed the sale and issuance of an aggregate of 6,037,500 shares of our common stock, including the
−Removed: exercise in full of the Overallotment Option.
−Removed: The net proceeds to us from the July 2023 Public
−Removed: Offering were approximately $5.2 million after deducting underwriting discounts and other offering expenses payable by the Company.
+Added: Monetization Event as defined in the Debt Facility Agreement or a change of control, or (iii) at the Lender’s option, upon the occurrence
+Added: and during the continuance of an event of default under the Debt Facility Agreement.
+Added: On November 7, 2024, the Company terminated the Debt
+Added: Facility Agreement, and no amounts were drawn under the Debt Facility Agreement.
+Added: Total costs incurred under the debt facility financing
+Added: was $0.4 million.
Funding Requirements
−Removed: As noted above, certain of our cash requirements
−Removed: relate to the funding of our ongoing product development and commercialization operations and our milestone and royalty obligations under
−Removed: our intellectual property licenses with WARF and Mayo.
−Removed: See “Item 1—Business—Clinical
−Removed: Development and Regulatory Pathway—Clinical Experience, Future Development and Clinical Trial Plans” of this Report for a
−Removed: discussion of design, development, pre-clinical and clinical activities that we may conduct in the future, including expected cash expenditures
−Removed: required for some of those activities, to the extent we are able to estimate such costs.
−Removed: On January 21, 2020,
−Removed: we entered into an Amended and Restated License Agreement (the “WARF License”) with WARF, which amended and restated in full
−Removed: our prior license agreement with WARF, dated October 1, 2014.
−Removed: Under the WARF License, we have agreed to pay WARF a royalty equal to a
−Removed: single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000 for 2020,
−Removed: $100,000 for 2021 and $150,000 for 2022 and each calendar year thereafter that the WARF License is in effect.
−Removed: If we or any of our sublicensees
−Removed: contest the validity of any licensed patent, the royalty rate will be doubled during the pendency of such contest and, if the contested
−Removed: patent is found to be valid and would be infringed by us if not for the WARF License, the royalty rate will be tripled for the remaining
−Removed: 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: 4 – Commitments and Contingencies” included in our financial statements included in “Item 8 — Financial
−Removed: Statements and Supplementary Data” in this Report.
−Removed: for more information about the WARF License
−Removed: and the Mayo Development Agreement.
+Added: Certain of our cash requirements relate to the
+Added: funding of our ongoing product development and commercialization operations and our milestone and royalty obligations under our intellectual
+Added: property licenses with WARF and Mayo.
+Added: See “Item 1—Business—Clinical Development
+Added: and Regulatory Pathway—Clinical Experience, Future Development and Clinical Trial Plans” of this Report for a discussion of
+Added: design, development, pre-clinical and clinical activities that we may conduct in the future, including expected cash expenditures required
+Added: for some of those activities, to the extent we are able to estimate such costs.
+Added: On January 21, 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.
+Added: Under the WARF License, we have agreed to pay WARF a royalty equal to a single-digit percentage of certain
+Added: of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000 for 2020, $100,000 for 2021 and $150,000
+Added: for 2022 and each calendar year thereafter that the WARF License is in effect.
+Added: If we or any of our sublicensees contest the validity of
+Added: any licensed patent, the royalty rate will be doubled during the pendency of such contest and, if the contested patent is found to be
+Added: valid and would be infringed by us if not for the WARF License, the royalty rate will be tripled for the remaining term of the WARF License.
+Added: Under the Amended and
+Added: Restated License and Development Agreement with Mayo (the “Mayo Development Agreement”), we have agreed to pay Mayo a royalty
+Added: equal to a single-digit percentage of certain of our product sales pursuant to the Mayo Development Agreement.
+Added: “Note 4 – Commitments and Contingencies” included in our financial statements included in “Item 8 —
+Added: Financial Statements and Supplementary Data” in this Report.
+Added: for more information about the
+Added: WARF License and the Mayo Development Agreement.
Our other cash requirements
7 unchanged sentences
periods up to fiscal year 2028.
−Removed: We expect to satisfy
−Removed: our short term and long term obligations through cash on hand and, until we generate an adequate level of revenue from commercial sales
−Removed: to cover expenses, if ever, from future equity and debt financings.
+Added: We expect to satisfy our short-term and long-term
+Added: obligations through cash on hand and revenue from commercial sales to cover expenses.
NeuroOne Medical Technologies Corporation
1 unchanged sentence
For a discussion of potential fee payments under
−Removed: the Zimmer Distribution Agreement, see “Note 7 — Zimmer Distribution Agreement and Other Product Revenue” included in
−Removed: our financial statements included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
−Removed: we have received regulatory clearance to expand the use of our Evo sEEG electrode technology for up to 30 days, commercial sales of the
−Removed: sEEG electrodes and OneRF Products are expected to take some time to be a significant source of liquidity.
−Removed: Zimmer has exclusive global
−Removed: rights to distribute our strip and grid cortical electrodes, depth electrodes and electrode cable assembly products.
−Removed: Zimmer’s failure
−Removed: to timely develop or commercialize these products would have a material adverse effect on our business and operating results.
−Removed: October 2024, we entered into an Amended and Restated Distribution Agreement with Zimmer to provide Zimmer with the exclusive right and
−Removed: license to distribute also our OneRF Ablation System for an upfront payment of $3.0 million, with eligibility for an additional $1.0 million
−Removed: payment from Zimmer upon achievement of certain specified net sales milestones.
−Removed: As of September 30, 2024, we had cash and cash
−Removed: equivalents in the aggregate of approximately $1.5 million.
−Removed: Management has noted the existence of substantial doubt about our ability
−Removed: to continue as a going concern.
−Removed: Additionally, our independent registered public accounting firm included an explanatory paragraph in the
−Removed: report on our financial statements as of and for the years ended September 30, 2024 and 2023, respectively, noting the existence of substantial
+Added: the Amended and Restated Zimmer Development Agreement, see “Note 7 — Zimmer Distribution Agreement and Other Product Revenue”
+Added: included in our financial statements included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
+Added: Even though we have received regulatory clearance to expand the use of our Evo sEEG electrode technology for up to 30 days, commercial
+Added: sales of the sEEG electrodes and OneRF Ablation System are expected to take some time to be a significant source of liquidity.
+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: In October 2024, we entered into an Amended and Restated Distribution Agreement with Zimmer to provide Zimmer with the
+Added: exclusive right and license to distribute our OneRF Ablation System in the brain for an upfront payment of $3.0 million, with eligibility
+Added: for an additional $1.0 million payment from Zimmer upon achievement of certain specified net sales milestones.
+Added: At September 30, 2025, we had cash and cash equivalents
+Added: in the aggregate of approximately $6.6 million.
+Added: Management has noted the existence of substantial doubt about our ability to continue
+Added: as a going concern.
+Added: Additionally, our independent registered public accounting firm included an explanatory paragraph in the report on
+Added: our financial statements as of and for the years ended September 30, 2025 and 2024, respectively, noting the existence of substantial
doubt about our ability to continue as a going concern.
2 unchanged sentences
To continue to fund operations, we will need to secure additional
−Removed: funding through public or private equity or debt financings, through collaborations or partnerships with other companies or other sources.
−Removed: We may not be able to raise additional capital on terms acceptable to us, or at all.
−Removed: Any failure to raise capital when needed could compromise
−Removed: our ability to execute on our business plan.
−Removed: If we are unable to raise additional funds, or if our anticipated operating results are not
−Removed: achieved, we believe planned expenditures may need to be reduced in order to extend the time period that existing resources can fund our
−Removed: If we are unable to obtain the necessary capital, it may have a material adverse effect on our operations and the development
−Removed: of our technology, or we may have to cease operations altogether.
+Added: funding through public or private equity or debt financing, through collaborations or partnerships with other companies, or other sources.
+Added: We may not be able to raise additional capital
+Added: on terms acceptable to us, or at all.
+Added: Any failure to raise capital when needed could compromise our ability to execute on our business
+Added: If we are unable to raise additional funds, or if our anticipated operating results are not achieved, we believe planned expenditures
+Added: may need to be reduced in order to extend the time period that existing resources can fund our operations.
+Added: If we are unable to obtain
+Added: the necessary capital in the future from operating results or future financing, it may have a material adverse effect on our operations
+Added: and the development of our technology, or we may have to cease operations altogether.
The development and commercialization of our cortical
7 unchanged sentences
We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.
+Added: Our other cash requirements
+Added: within the next twelve months include accounts payable, accrued expenses, purchase commitments and other current liabilities.
+Added: cash requirements greater than twelve months from various contractual obligations and commitments include operating leases and contracted
+Added: We expect to satisfy
+Added: our short term and long term obligations through cash on hand and, until we generate an adequate level of revenue from commercial sales
+Added: to cover expenses, if ever, from future equity and debt financings.
The following is a summary of cash flows for each
5 unchanged sentences
$ (11,011,840 )
−Removed: Net cash (used in) provided by investing activities
+Added: Net cash used in investing activities
Net cash provided by financing activities
−Removed: Net decrease in cash and cash equivalents
−Removed: $ (3,862,451 )
+Added: Net increase (decrease) in cash and cash equivalents
$ (3,862,451 )
2 unchanged sentences
Net cash used in operating activities was $2.8
−Removed: million for the year ended September 30, 2024, which consisted of a net loss of $12.3 million partially offset by non-cash stock-based
−Removed: compensation, depreciation, amortization related to intangible assets and deferred financing costs, operating lease expense, fair value
−Removed: change in warrant liability and the proceeds from the issuance of warrants in connection with the 2024 Private Placement totaling approximately
−Removed: $2.3 million in the aggregate.
−Removed: The net change in our net operating assets and liabilities associated with fluctuations in our operating
−Removed: activities resulted in a cash use of approximately $1.0 million.
−Removed: The net cash use stemming from the change in operating assets and liabilities
−Removed: was primarily attributable to an increase in inventory purchases and to an increases in our accounts receivable attributed largely to
−Removed: the timing of customer payments.
−Removed: Partially offsetting the net cash operating use during the period was an increase in our accounts payable
−Removed: and accrued expenses coupled with a decrease in prepaid expenses resulting from timing of payments and fluctuations in our operations.
+Added: million for the year ended September 30, 2025, which consisted of a net loss of $3.6 million partially offset principally by non-cash
+Added: stock-based compensation, depreciation, amortization related to intangible assets and deferred issuance costs, operating lease expense,
+Added: fair value change in warrant liability totaling approximately $1.1 million in the aggregate.
+Added: Our net loss was further adjusted to account
+Added: for the reclassification of debt and equity facility termination costs to financing activities in the amount of $0.1 million.
+Added: net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash use
+Added: of approximately $0.4 million.
+Added: The net cash use stemming from the change in operating assets and liabilities was primarily attributable
+Added: to an increase in our accounts receivable attributed largely to the timing of customer payments.
+Added: Partially offsetting the net cash operating
+Added: use during the period was a decrease in our inventory and prepaid expenses as well as a net increase in our accounts payable and accrued
+Added: expenses resulting from timing of payments and fluctuations in our operations.
Net cash used in operating activities was $11.0
−Removed: million for the year ended September 30, 2023, which consisted of a net loss of $11.9 million partially offset by non-cash stock-based
−Removed: compensation, depreciation, amortization related to intangible assets and short term investment premiums and discounts, operating lease
−Removed: expense and loss on disposal of fixed assets, totaling approximately $1.4 million in the aggregate.
−Removed: The net change in our net operating
−Removed: assets and liabilities associated with fluctuations in our operating activities resulted in a cash use of approximately $2.4 million.
−Removed: The net cash use stemming from the change in operating assets and liabilities was primarily attributable to both a decrease in deferred
−Removed: revenue in connection with the completion of the remaining milestone performance obligation under the Zimmer Distribution Agreement and
−Removed: to an increase in inventory purchases, attributed to the timing of payments.
−Removed: Partially offsetting the net cash operating use during the
−Removed: period was a decrease in our accounts receivable, prepaid expenses and by an increase in our accrued expenses, on a net basis, resulting
−Removed: from timing of payments and fluctuations in our operations.
−Removed: Net cash (used in) provided by investing activities
+Added: million for the year ended September 30, 2024, which consisted of a net loss of $12.3 million partially offset principally by non-cash
+Added: stock-based compensation, depreciation, amortization related to intangible assets and deferred issuance costs, operating lease expense,
+Added: fair value change in warrant liability and the proceeds from the issuance of warrants in connection with the 2024 Private Placement totaling
+Added: approximately $2.2 million in the aggregate.
+Added: Our net loss was further adjusted to account for the reclassification of debt and equity
+Added: facility termination costs to financing activities in the amount of $0.1 million.
+Added: net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash use
+Added: of approximately $1.0 million.
+Added: The net cash use stemming from the change in operating assets and liabilities was primarily attributable
+Added: to an increase in inventory purchases and to an increases in our accounts receivable attributed largely to the timing of customer payments.
+Added: Partially offsetting the net cash operating use during the period was an increase in our accounts payable and accrued expenses coupled
+Added: with a decrease in prepaid expenses resulting from timing of payments and fluctuations in our operations.
+Added: Net cash used in investing activities
Net cash used in investing activities was $0.1
−Removed: million for the year ended September 30, 2024 and consisted of outlays for purchases of property and equipment.
−Removed: Net cash provided by investing activities was
−Removed: $2.6 million for the year ended September 30, 2023 and consisted of maturities of short-term investments in the amount of $4.5 million,
−Removed: offset by purchases of short term investments of $1.5 million, consisting of treasury and corporate notes.
−Removed: The balance of activity during
−Removed: the period consisted of outlays for purchases of property and equipment in the amount $0.4 million offset slightly by net proceeds associated
−Removed: with the disposal of equipment.
+Added: million for each of the years ended September 30, 2025 and 2024 consisting of outlays for purchases of property and equipment.
Net cash provided by financing activities
Net cash provided by financing activities was
−Removed: $7.3 million for the year ended September 30, 2024, which consisted of net proceeds from the ATM of $4.8 million and net proceeds from
−Removed: the 2024 Private Placement of $2.6 million, offset partially by repurchases of common stock for the payment of employee taxes in the amount
−Removed: of $81,000 and debt facility issuance costs of approximately $75,000.
−Removed: Net cash provided by financing activities was
−Removed: $7.4 million for the year ended September 30, 2023, which consisted of net proceeds from the July 2023 Public Offering of $5.2 million
−Removed: and from the ATM of $2.3 million, offset partially by repurchases of common stock for the payment of employee taxes in the amount of $0.1
+Added: $8.0 million for the year ended September 30, 2025, which consisted of net proceeds from the April 2025 Financing of approximately $8.2
+Added: million and from the ATM Program in the amount of approximately $0.3 million as well as from the exercise of warrants in the amount of
+Added: $0.1 million.
+Added: Offsetting the net proceeds were debt facility issuance costs of $0.3 million, issuance costs paid in connection with a
+Added: prior year private placement of approximately $0.2 million and as a result of the repurchases of common stock for the payment of employee
+Added: taxes in the amount of $0.1 million.
+Added: Net cash provided by financing activities
+Added: was $7.3 million for the year ended September 30, 2024, which consisted of net proceeds from the ATM Program of $4.8 million and net proceeds
+Added: from the 2024 Private Placement of $2.6 million, offset partially by repurchases of common stock for the payment of employee taxes in
+Added: the amount of $81,000 and debt facility issuance costs of approximately $75,000.
+Added: NeuroOne Medical Technologies Corporation
Critical Accounting Policies and Significant
13 unchanged sentences
8 — Financial Statements and Supplementary Data” in this Report.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: policies, the following are considered critical to an understanding of our financial statements included in “Item 8 — Financial
−Removed: Statements and Supplementary Data” in this Report that require the application of the most subjective and the most complex judgments:
+Added: Of these policies, the
+Added: following are considered critical to an understanding of our financial statements included in “Item 8 — Financial Statements
+Added: and Supplementary Data” in this Report that require the application of the most subjective and the most complex judgments:
For discussion about the determination of collaborations
3 unchanged sentences
chargebacks, sales allowances and sales returns.
−Removed: Stock-based Compensation
−Removed: For discussions about the application of grant
−Removed: date fair value associated with our stock-based compensation, see “Note 8 — Stock-Based Compensation” included in “Item
−Removed: 8 — Financial Statements and Supplementary Data” in this Report.
Fair Value of Warrant
8 unchanged sentences
Equity” included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
−Removed: Income Tax Assets
−Removed: and Liabilities
−Removed: Income tax assets and liabilities include income
−Removed: tax valuation allowances.
−Removed: For additional information, see “Note 12 — Income Taxes” included in “Item 8 —
−Removed: Financial Statements and Supplementary Data” in this Report.
−Removed: Contingencies
−Removed: We are subject to numerous contingencies arising
−Removed: in the ordinary course of business, including legal contingencies.
−Removed: For additional information, see “Note 4 — Commitments
−Removed: and Contingencies” included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
Recent Accounting Pronouncements
2 unchanged sentences
the impact of certain recent accounting pronouncements on our financial statements.
−Removed: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES
+Added: ABOUT MARKET RISK
Not applicable.
1 unchanged sentence
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.