1 unchanged sentence
Condition and Results of Operations
−Removed: The following discussion of our financial condition
−Removed: and results of operations should be read in conjunction with the financial statements and notes included in Part I “Financial Information”,
−Removed: Item I “Financial Statements” of this Quarterly Report on Form 10-Q (the “Report”) and the audited financial statements
−Removed: and related footnotes included in our Annual Report on Form 10-K for the year ended September 30, 2024.
−Removed: Forward-Looking Statements
This Report contains forward-looking statements
10 unchanged sentences
Forward-looking statements include statements about:
−Removed: ability to maintain regulatory clearance of our cortical strip and grid electrode technology, and our OneRF ablation system;
−Removed: ability to successfully commercialize our technology in the United States;
−Removed: ability to achieve or sustain profitability;
−Removed: ability to raise additional capital and to fund our operations;
−Removed: availability of additional capital on acceptable terms or at all as or when needed;
−Removed: clinical utility of our cortical strip, grid and depth electrode, RF ablation system, and technology under development;
−Removed: ability to develop additional applications of our cortical strip, grid and depth electrode technology with the benefits we hope to offer
−Removed: as compared to existing technology, or at all;
−Removed: results of our development and distribution relationship with Zimmer, Inc.
−Removed: have been the victim of a cyber-related crime, and our controls may not be successful in avoiding future cyber-related crimes;
−Removed: performance, productivity, reliability and regulatory compliance of our third-party manufacturers of our cortical strip, grid electrode
−Removed: and depth electrode and RF ablation technology;
−Removed: ability to develop future generations of our cortical strip, grid and depth electrode technology;
−Removed: future development priorities;
−Removed: ability to obtain reimbursement coverage for our cortical strip, grid and depth electrode technology;
−Removed: expectations about the willingness of healthcare providers to recommend our cortical strip, grid and depth electrode and RF ablation
−Removed: technology to people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries
−Removed: and other related neurological disorders;
+Added: our ability to maintain regulatory clearance of our cortical strip and grid electrode technology, and our OneRF ablation system;
+Added: our ability to successfully commercialize our technology in the United States;
+Added: our ability to achieve or sustain profitability;
+Added: our ability to raise additional capital and to fund our operations;
+Added: the availability of additional capital on acceptable terms or at all as or when needed;
+Added: the clinical utility of our cortical strip, grid and depth electrode, RF ablation system, and technology under development;
+Added: our ability to develop additional applications of our cortical strip, grid and depth electrode technology with the benefits we hope to offer as compared to existing technology, or at all;
+Added: the results of our development and distribution relationship with Zimmer, Inc.
+Added: we have been the victim of a cyber-related crime, and our controls may not be successful in avoiding future cyber-related crimes;
+Added: the performance, productivity, reliability and regulatory compliance of our third-party manufacturers of our cortical strip, grid electrode and depth electrode and RF ablation technology;
+Added: our ability to develop future generations of our cortical strip, grid and depth electrode technology;
+Added: our future development priorities;
+Added: our ability to obtain reimbursement coverage for our cortical strip, grid and depth electrode technology;
+Added: our expectations about the willingness of healthcare providers to recommend our cortical strip, grid and depth electrode and RF ablation technology to people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders;
+Added: our future commercialization, marketing and manufacturing capabilities and strategy;
+Added: our ability to comply with applicable regulatory requirements;
+Added: our ability to maintain our intellectual property position;
NeuroOne Medical Technologies Corporation
−Removed: future commercialization, marketing and manufacturing capabilities and strategy;
−Removed: ability to comply with applicable regulatory requirements;
−Removed: ability to maintain our intellectual property position;
−Removed: expectations regarding international opportunities for commercializing our cortical strip, grid and depth electrode technology under
−Removed: including technology under development;
−Removed: estimates regarding the size of, and future growth in, the market for our technology, including technology under development;
−Removed: estimates regarding our future expenses and needs for additional financing.
+Added: our expectations regarding international opportunities for commercializing our cortical strip, grid and depth electrode technology under including technology under development;
+Added: our estimates regarding the size of, and future growth in, the market for our technology, including technology under development;
+Added: our estimates regarding our future expenses and needs for additional financing.
Forward-looking statements are based on management’s
25 unchanged sentences
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
−Removed: under development.
−Removed: We distribute our cEEG strip/grid electrodes,
−Removed: cable assembly products and our OneRF Ablation System with Zimmer Biomet.
+Added: We have received 510(k) clearance for three of
+Added: our devices from the FDA, including:
+Added: (i) our Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue
+Added: for up to 30 days, (ii) our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation
+Added: equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, and (iii) our OneRF
+Added: ablation system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
+Added: Our other products are
+Added: still under development.
+Added: We distribute each of these three devices with Zimmer Biomet.
We have incurred mostly losses since inception.
−Removed: As of December 31, 2024, we had an accumulated deficit of $73.2 million, primarily as a result of expenses incurred in connection with
−Removed: our research and development, selling, general and administrative expenses associated with our operations and interest expense, fair value
+Added: As of March 31, 2025, we had an accumulated deficit of $75.5 million, primarily as a result of expenses incurred in connection with our
+Added: research and development, selling, general and administrative expenses associated with our operations and interest expense, fair value
adjustments and loss on extinguishments related to our debt, offset in part by license and product revenues.
−Removed: NeuroOne Medical Technologies Corporation
Prior to FDA clearance of certain of our products,
2 unchanged sentences
See “ Liquidity and Capital Resources—Capital Resources ” below.
−Removed: While we have begun to
−Removed: generate revenue from the sale of products based on our cEEG and sEEG technology, and OneRF System, and through milestone and other payments
−Removed: from our current collaboration and distribution arrangement 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 additional funds when
−Removed: needed on favorable terms or at all.
−Removed: Our failure to raise such capital as and when needed would have a negative impact on our financial
−Removed: condition and our ability to develop and commercialize our cortical strip, grid electrode and depth electrode technology and future products
−Removed: and our ability to pursue our business strategy.
−Removed: See “Liquidity and Capital Resources—Liquidity Outlook” below.
+Added: While we have begun
+Added: to generate revenue from the sale of products based on our cEEG and sEEG technology, and OneRF System, and through milestone and other
+Added: payments from our current collaboration and distribution arrangement with Zimmer, we expect to continue to incur significant expenses
+Added: and may incur increasing operating and net losses for the foreseeable future until we generate a higher level of revenue from commercial
+Added: NeuroOne Medical Technologies Corporation
Recent Developments
Corporate Updates
+Added: 510(k) Submission for Trigeminal Facial Pain
+Added: On April 22, 2025, we filed a 510(k) submission
+Added: to the FDA for our OneRF® Trigeminal Nerve Ablation System to treat facial pain.
+Added: 2025 Financing
+Added: 4, 2025, we entered into an Underwriting Agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co.
+Added: underwriter (the “Underwriter”), relating to the issuance and sale of 16,000,000 shares of the Company’s common stock,
+Added: at a price to the public of $0.50 per share (the “April 2025 Financing”).
+Added: In addition, under the terms of the Underwriting
+Added: Agreement, we granted the Underwriter an option, exercisable for 45 days, to purchase up to an additional 2,400,000 shares of common stock
+Added: on the same terms as the offering, which was exercised in full.
+Added: Net proceeds to the Company were approximately $8.2 million.
Zimmer Amended and Restated Distribution Agreement
20 unchanged sentences
sales volume threshold.
−Removed: NeuroOne Medical Technologies Corporation
The revised term under the Amendment (the “Term”)
9 unchanged sentences
for the OneRF™ Product System (the “RF Term”).
−Removed: Nasdaq Notice
−Removed: As previously reported, on July 11, 2024, we received
−Removed: a letter (the “Bid Price Deficiency Notice”) from the Listing Qualifications Department (the “Staff”) of the Nasdaq
−Removed: Stock Market (“Nasdaq”) notifying the Company that, because the closing bid price for its common stock had been below $1.00
−Removed: per share for 30 consecutive trading days, it was not compliant with Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price
−Removed: Requirement”).
−Removed: In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), we had a period of 180 calendar days from July 11, 2024,
−Removed: or until January 7, 2025, to regain compliance with the Minimum Bid Price Requirement.
−Removed: On January 8, 2025, we received a letter from
−Removed: the Staff indicating the Company’s continued non-compliance with the Minimum Bid Price Requirement.
−Removed: The letter further informed
−Removed: us that our common stock would be delisted from the Nasdaq Capital Market unless the Company appeals the Staff’s delisting determination
−Removed: by requesting a hearing before the Nasdaq Hearings Panel (the “Panel”).
−Removed: On January 15, 2025, the Company requested a hearing
−Removed: before the Panel to appeal the determination by the Staff, and to present its plan to regain and sustain compliance with the Minimum Bid
−Removed: Price Requirement.
−Removed: The request was granted and a hearing was scheduled for February 20, 2025.
−Removed: O n February 3, 2025,
−Removed: the Company received a letter from the Staff of Nasdaq that the Company’s bid price deficiency had been cured and that the Company
−Removed: was in compliance with all applicable listing standards.
−Removed: Based on the foregoing, the previously scheduled
−Removed: Nasdaq hearing has been cancelled and the matter is now closed.
−Removed: Debt Facility Agreement
−Removed: In August 2024, we entered into a loan and security
−Removed: agreement (the “Debt Facility Agreement”) with Growth Opportunity Funding, LLC, as the Lender, which provided for a delayed
−Removed: draw term loan facility in an aggregate principal amount not to exceed $3.0 million.
−Removed: On November 7, 2024, we mutually agreed with the
−Removed: Lender to terminate the loan facility under which no amounts were drawn under the facility.
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 do not currently
+Added: anticipate any meaningful impact from current or proposed tariffs on imported goods.
NeuroOne Medical Technologies Corporation
12 unchanged sentences
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: We have received FDA 510(k) clearance for our
+Added: cortical electrode for temporary (less than 30 days) recording, monitoring, and stimulation on the surface of the brain, our Evo sEEG
+Added: electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring,
+Added: and stimulation of electrical signals at the subsurface level of the brain, and our OneRF Ablation System for creation of radiofrequency
+Added: lesions in nervous tissue for functional neurosurgical procedure.
Product Gross Profit
13 unchanged sentences
Revenue recognized under
−Removed: the Amendment during the three months ending December 31, 2024 was $3.0 million.
−Removed: For further discussion about the determination of
−Removed: license revenue, product revenue and cost of product revenue, and for a discussion of milestones and royalty payments under the Amended
−Removed: and Restated Zimmer Distribution Agreement, see “—Liquidity and Capital Resources—Liquidity Outlook” below and
−Removed: see “Note 7 — Zimmer Distribution Agreement and Other Product Revenue” included in our condensed financial statements
−Removed: included in “Part 1, Item 1 – Financial Statements” in this Report.
+Added: the Amendment during the six months ending March 31, 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 Amended and Restated
+Added: Zimmer 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 condensed financial statements included in “Part
+Added: 1, Item 1 – Financial Statements” in this Report.
Selling, General and Administrative
16 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.
Fair Value Change in Warrant Liability
7 unchanged sentences
Results of Operations
−Removed: Comparison of the Three Months Ended December 31, 2024 and 2023
+Added: Comparison of the Three Months Ended March
+Added: 31, 2025 and 2024
The following table sets forth the results of
−Removed: operations for the three months ended December 31, 2024 and 2023, respectively.
−Removed: For the three months ended
+Added: operations for the three months ended March 31, 2025 and 2024, respectively.
+Added: Three Months Ended
Product revenue
1 unchanged sentence
Product gross profit
−Removed: License revenue
Operating expenses:
2 unchanged sentences
Total operating expenses
−Removed: Income (loss) from operations
+Added: Loss from operations
Fair value change in warrant liability
−Removed: Financing cost
−Removed: Income (loss) before income taxes
+Added: Loss before income taxes
Provision for income taxes
−Removed: Net income (loss)
$ (2,270,607 )
+Added: $ (2,855,090 )
NeuroOne Medical Technologies Corporation
1 unchanged sentence
Product revenue was $1.4 million during the three
−Removed: months ended December 31, 2024 with a gross profit and gross profit percentage of $1.9 million and 58.9%, respectively.
−Removed: Product revenue
−Removed: was $1.0 million during the three months ended December 31, 2023 with a gross profit and gross profit percentage of $0.3 million and 27.2%,
−Removed: respectively.
−Removed: The increase in gross profit percentage during the current period was largely due to the higher sales volume that exceeded
−Removed: fixed royalty and overhead period costs and due to lower overall material supply costs in the current period.
−Removed: Product revenue consisted
−Removed: of Strip/Grid Products, sEEG Products, OneRF Products and Electrode Cable Assembly Products sales.
−Removed: The cost of product revenue consisted
−Removed: of the manufacturing and materials costs incurred by our third-party contract manufacturers in connection with our Strip/Grid Products,
−Removed: sEEG Products and OneRF Products, and outside supplier materials costs in connection with the Electrode Cable Assembly Products.
−Removed: cost of product revenue included royalty fees incurred of approximately $38,000 in connection with our license agreements during each
−Removed: of the three months ended December 31, 2024 and 2023, respectively.
−Removed: License Revenue
−Removed: License revenue was $3.0 million for the three
−Removed: months ended December 31, 2024.
−Removed: License revenue during the current period related to the distribution license granted to Zimmer for the
−Removed: OneRF Product in October 2024.
−Removed: No license revenue was generated from the Amended and Restated Zimmer Development Agreement during the
−Removed: three months ended December 31, 2023.
+Added: months ended March 31, 2025 with a gross profit and gross profit percentage of $0.8 million and 55.6%, respectively.
+Added: Product revenue was
+Added: $1.4 million during the three months ended March 31, 2024 with a gross profit and gross profit percentage of $0.4 million and 28.3%, respectively.
+Added: The increase in gross profit percentage during the current period was largely due to the higher margin OneRF Products being sold in the
+Added: current period under the Amendment with Zimmer.
+Added: Product revenue consisted of Strip/Grid Products, sEEG Products, Electrode Cable Assembly
+Added: Products, and for the current three-month period, OneRF Product sales.
+Added: The cost of product revenue consisted of the manufacturing and
+Added: materials costs incurred by our third-party contract manufacturers in connection with our Strip/Grid Products, sEEG Products and OneRF
+Added: Products, and outside supplier materials costs in connection with the Electrode Cable Assembly.
+Added: In addition, cost of product revenue included
+Added: royalty fees incurred of approximately $38,000 and $42,000 in connection with our license agreements during the three months ended March
+Added: 31, 2025 and 2024, respectively.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were
−Removed: $2.0 million for the three months ended December 31, 2024, compared to $2.2 million for the three months ended December 31, 2023.
−Removed: $130,000 decrease was primarily due to an overall decrease in legal, investor relations, and other professional service fees.
−Removed: general and administrative expenses included stock-based compensation of $270,000 and $243,000 during the three months ended December
−Removed: 31, 2024 and 2023, respectively.
+Added: $1.9 million and $2.0 million during the three months ended March 31, 2025 and 2024, respectively.
+Added: The $0.1 million expense decrease in
+Added: the current quarter over the comparable prior year quarter was largely attributed to lower administrative payroll and stock-based compensation
+Added: of $0.1 million, lower legal costs of $0.1 million and lower public company costs of $0.1 million, partially offset by higher professional
+Added: services and marketing expenses of $0.2 million.
+Added: Selling, general and administrative expenses included $0.2 million and $0.3 million of
+Added: stock-based compensation during the three months ended March 31, 2025 and 2024, respectively.
Research and Development Expenses
Research and development expenses were $1.5 million
−Removed: for the three months ended December 31, 2024, compared to $1.5 million during the three months ended December 31, 2023.
−Removed: The $0.3 million
−Removed: decrease period over period was attributed largely to the timing of development of activities, which primarily included salary-related
−Removed: expenses and costs related to consulting services, materials and supplies associated with the development of OneRF Products, depth electrode
−Removed: products and to a lesser extent strip/grid products.
−Removed: Research and development expenses included stock-based compensation of $70,000 and
−Removed: $65,000 during the three months ended December 31, 2024 and 2023, respectively.
+Added: for the three months ended March 31, 2025, compared to $1.3 million for the three months ended March 31, 2024.
+Added: The $0.2 million increase
+Added: in the current period over the prior year period was attributed largely to the timing of product development activities in the current
+Added: quarter when compared to the comparable prior year quarter.
+Added: Research and development expenses primarily included salary-related expenses
+Added: and costs related to consulting services, materials and supplies associated with the development of sEEG Products and to a much lesser
+Added: extent Strip/Grid Products.
+Added: Research and development expenses included $55,000 and $76,000 of stock-based compensation during the three
+Added: months ended March 31, 2025 and 2024, respectively.
+Added: Fair Value Change
+Added: in Warrant Liability
+Added: The net change in fair
+Added: value of the warrant liability during the three months ended March 31, 2025 was $0.4 million benefit.
+Added: The change was due primarily to
+Added: fluctuations in our common stock fair value.
+Added: There were no warrants outstanding during the three months ended March 31, 2024 that were
+Added: measured on a fair value basis.
+Added: Other income during the three months ended March
+Added: 31, 2025 and 2024 related to interest income on our cash, cash equivalents and short-term investments in the amount of $19,000 and $31,000,
+Added: respectively.
+Added: NeuroOne Medical Technologies Corporation
+Added: Comparison of the Six Months Ended March 31,
+Added: 2025 and 2024
+Added: The following table sets forth the results of
+Added: operations for the six months ended March 31, 2025 and 2024, respectively.
+Added: Six Months Ended
+Added: Product revenue
+Added: Cost of product revenue
+Added: Product gross profit
+Added: License revenue
+Added: Operating expenses:
+Added: Selling, general and administrative
+Added: Research and development
+Added: Total operating expenses
+Added: Loss from operations
Fair value change in warrant liability
−Removed: The net change in fair value of the warrant liability
−Removed: during the three months ended December 31, 2024 was $0.4 million benefit.
−Removed: The change was due primarily to fluctuations in our common stock
−Removed: There were no warrants outstanding during the three months ended December 31, 2023 that were measured on a fair value basis.
Financing costs
−Removed: Financing costs during the three months ended
−Removed: December 31, 2024 consisted of the amortization of the deferred issuance costs associated with the debt facility (described further below)
−Removed: in the amount of $0.2 million and additional legal and loan facility termination costs of $0.1 million upon the termination of the Debt
−Removed: Facility in November 2024.
−Removed: We did not incur any financing costs during the three months ended December 31, 2023.
−Removed: Other income during the three months ended December
−Removed: 31, 2024 consisted of interest income in the amount of $9,000 attributed to our cash and cash equivalents.
−Removed: Other income during the three months ended December
−Removed: 31, 2023 consisted of interest income in the amount of $46,000 attributed to our cash and cash equivalents.
+Added: Loss before income taxes
+Added: Provision for income taxes
+Added: $ (6,199,990 )
+Added: Product Revenue and Product Gross Profit
+Added: Product revenue was $4.7 million during the six
+Added: months ended March 31, 2025 with a gross profit and gross profit percentage of $2.7 million and 57.9%, respectively.
+Added: Product revenue was
+Added: $2.4 million during the six months ended March 31, 2024 with a gross profit and gross profit percentage of $0.7 million and 27.9%, respectively.
+Added: The increase in gross profit percentage during the current period was largely due to higher margin OneRF Products being sold in the current
+Added: period under the Amendment with Zimmer.
+Added: Product revenue consisted of Strip/Grid Products, sEEG Products, Electrode Cable Assembly Products,
+Added: and for the current six-month period, OneRF Product sales.
+Added: The cost of product revenue consisted of the manufacturing and materials costs
+Added: incurred by our third-party contract manufacturers in connection with our Strip/Grid Products, sEEG Products and OneRF Products, and outside
+Added: supplier materials costs in connection with the Electrode Cable Assembly Products.
+Added: In addition, cost of product revenue included royalty
+Added: fees incurred of approximately $75,000 and $79,000 in connection with our license agreements during the six months ended March 31, 2025
+Added: and 2024, respectively.
+Added: License Revenue
+Added: License revenue was $3.0 million for the six months
+Added: ended March 31, 2025.
+Added: License revenue during the current period related to the distribution license granted to Zimmer for the OneRF Product
+Added: in October 2024.
+Added: No license revenue was generated from the Amended and Restated Zimmer Development Agreement during the six months ended
+Added: March 31, 2024.
NeuroOne Medical Technologies Corporation
+Added: Selling, General and Administrative Expenses
+Added: Selling, general and administrative expenses were
+Added: $4.0 million for the six months ended March 31, 2025, compared to $4.2 million for the six months ended March 31, 2024.
+Added: The $0.2 million
+Added: decrease in the current six-month period compared to the comparable prior year period was primarily due to lower administrative payroll
+Added: of $0.1 million, lower legal costs of $0.2 million, lower public company costs of $0.3 million, offset by higher professional fees of
+Added: $0.3 million and facility costs and other general operating expenses of $0.1 million on a net basis.
+Added: Selling, general and administrative
+Added: expenses included $0.5 million of stock-based compensation during each of the six months ended March 31, 2025 and 2024.
+Added: Research and Development Expenses
+Added: Research and development expenses were $2.7 million
+Added: for the six months ended March 31, 2025, compared to $2.8 million for the six months ended March 31, 2024.
+Added: The $0.1 million decrease period
+Added: over period was attributed to the timing and an overall reduction in OneRF Product development activities during the current six-month
+Added: period when compared to the comparable prior year period.
+Added: Research and development primarily included salary-related expenses and costs
+Added: related to consulting services, materials and supplies associated with the development of sEEG Products and to a much lesser extent Strip/Grid
+Added: Research and development expenses included $0.1 million of stock-based compensation during each of the six months ended March
+Added: 31, 2025 and 2024.
+Added: Fair Value Change
+Added: in Warrant Liability
+Added: The net change in fair
+Added: value of the warrant liability during the six months ended March 31, 2025 was $0.8 million.
+Added: The change was due primarily to fluctuations
+Added: in our common stock fair value.
+Added: There were no warrants outstanding during the six months ended March 31, 2024 that were measured on a
+Added: fair value basis.
+Added: Financing Costs
+Added: Financing costs during
+Added: the six months ended March 31, 2025 consisted of the amortization of the deferred issuance costs associated with the debt facility (described
+Added: further below) in the amount of $0.2 million and additional legal and loan facility termination costs of $0.1 million upon the termination
+Added: of the Debt Facility in November 2024.
+Added: We did not incur any financing costs during the six months ended March 31, 2024.
+Added: Other income during the six months ended March
+Added: 31, 2025 and 2024 consisted of $28,000 and $77,000 related to interest income attributed to our cash and cash equivalents, respectively.
Liquidity and Capital Resources
−Removed: As of December 31, 2024, our principal source
−Removed: of liquidity consisted of cash and cash equivalents in the aggregate of approximately $1.1 million.
−Removed: While we began to generate revenue
−Removed: in fiscal year 2021 from commercial sales and through milestone and other payments under our agreement 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 which
−Removed: was ultimately not used.
+Added: As of March 31, 2025, our principal source of
+Added: liquidity consisted of cash and cash equivalents in the aggregate of approximately $1.3 million.
+Added: Subsequently, on April 7, 2025, we received
+Added: net proceeds of approximately $8.2 million from the April 2025 Financing.
+Added: NeuroOne Medical Technologies Corporation
Capital Resources
2 unchanged sentences
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 (the “Underwriting Agreement”) with Ladenburg Thalmann & Co.
+Added: underwriter (the “Underwriter”), relating to the issuance and sale of 16,000,000 shares of our common stock, at a price to
+Added: the public of $0.50 (the “April 2025 Financing”).
+Added: In addition, under the terms of the Underwriting Agreement, we granted the
+Added: Underwriter an option, exercisable for 45 days, to purchase up to an additional 2,400,000 shares of common stock on the same terms as
+Added: the offering, which was exercised in full.
+Added: Issuance costs in connection with the April 2025 Financing amounted to approximately $1.0 million
+Added: which included a 7.0% commission to the Underwriter and legal and other expenses in the amount of $0.3 million.
+Added: The Company received approximately
+Added: $8.2 million in net proceeds.
August 2024 Private Placement
28 unchanged sentences
including the shares of common stock previously sold.
−Removed: Through December 31, 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 $0.6
−Removed: million through December 31, 2024, of which $83,000 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.
−Removed: NeuroOne Medical Technologies Corporation
+Added: Through March 31, 2025, we have issued 5,544,489 shares of common stock under the
+Added: ATM for gross proceeds in the amount of $8.0 million.
+Added: We incurred issuance costs in connection with the ATM in the amount of $0.6 million
+Added: through March 31, 2025.
+Added: On August 16, 2024, we increased the amount of common stock that can be sold pursuant to the Sales Agreement by
+Added: $3.0 million.
+Added: On April 3, 2025, we decreased the amount of common stock that can be sold pursuant to the Sales Agreement to zero.
Debt Facility Financing
−Removed: On August 2, 2024, we entered into the Debt Facility
−Removed: Agreement with Growth Opportunity Funding, LLC, as the Lender, which provided for a delayed draw term loan facility in an aggregate principal
−Removed: amount not to exceed $3.0 million.
−Removed: We were permitted to borrow loans under the Debt Facility Agreement from time to time, for general
−Removed: corporate purposes and subject to certain specified conditions, until the earliest of:
−Removed: (i) November 30, 2024, (ii) the occurrence of any
−Removed: Monetization Event as defined in the Debt Facility Agreement or a change of control, or (iii) at the Lender’s option, upon the occurrence
−Removed: and during the continuance of an event of default under the Debt Facility Agreement.
−Removed: On November 7, 2024, the Company terminated the Debt
−Removed: Facility Agreement, and no amounts were drawn under the Debt Facility Agreement.
−Removed: Total costs incurred under the debt facility financing
−Removed: was $0.4 million.
−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: On August 2, 2024, we entered into the Debt
+Added: Facility Agreement with Growth Opportunity Funding, LLC, as the Lender, which provided for a delayed draw term loan facility in an
+Added: aggregate principal amount not to exceed $3.0 million.
+Added: We were permitted to borrow loans under the Debt Facility Agreement from time
+Added: to time, for general corporate purposes and subject to certain specified conditions, until the earliest of:
+Added: (i) November 30, 2024,
+Added: (ii) the occurrence of any Monetization Event as defined in the Debt Facility Agreement or a change of control, or (iii) at the
+Added: Lender’s option, upon the occurrence and during the continuance of an event of default under the Debt Facility Agreement.
+Added: November 7, 2024, the Company terminated the Debt Facility Agreement, and no amounts were drawn under the Debt Facility
+Added: Total costs incurred under the debt facility financing was $0.4 million.
+Added: NeuroOne Medical Technologies Corporation
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 Development and Regulatory Pathway—Clinical
+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 “Part 1, Item 1—Business—Clinical Development and Regulatory Pathway—Clinical
Experience, Future Development and Clinical Trial Plans” in our Annual Report on Form 10-K for the year ended September 30, 2024
10 unchanged sentences
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.
−Removed: NeuroOne Medical Technologies Corporation
Under the Amended and Restated License and Development
14 unchanged sentences
We expect to satisfy our short-term and long-term
−Removed: obligations through cash on hand and, until we generate an adequate level of revenue from commercial sales to cover expenses, if ever,
−Removed: from future equity and debt financings.
+Added: obligations through cash on hand and revenue from commercial sales to cover expenses.
Liquidity Outlook
10 unchanged sentences
million payment from Zimmer upon achievement of certain specified net sales milestones.
−Removed: At December 31, 2024, we had cash and cash equivalents
−Removed: in the aggregate of approximately $1.1 million.
−Removed: Management has noted the existence of substantial doubt about our ability to continue
−Removed: as a going concern.
−Removed: Additionally, our independent registered public accounting firm included an explanatory paragraph in the report on
−Removed: our financial statements as of and for the years ended September 30, 2024 and 2023, respectively, noting the existence of substantial
−Removed: doubt about our ability to continue as a going concern.
−Removed: Our existing cash and cash equivalents may not be sufficient to fund our operating
−Removed: expenses through at least twelve months from the date of this filing.
−Removed: 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: At March 31, 2025, we had cash and cash
+Added: equivalents in the aggregate of approximately $1.3 million.
+Added: Subsequently, on April 7, 2025, we received net proceeds of
+Added: approximately $8.2 million from the April 2025 Financing.
+Added: Our independent registered public accounting firm included an explanatory
+Added: paragraph in the report on our financial statements as of and for the years ended September 30, 2024 and 2023, respectively, noting
+Added: the existence of substantial doubt about our ability to continue as a going concern.
+Added: We believe our current available cash and cash
+Added: equivalents inclusive of the April 2025 Financing, coupled with the anticipated increase in product revenues from minimum purchases
+Added: and improved gross margins under the Zimmer Amendment and forecasted operating expense reductions, will be sufficient to fund our
+Added: planned expenditures and meet our obligations for at least twelve months from the date of issuance of these financial
+Added: NeuroOne Medical Technologies Corporation
+Added: In the future, however, in the absence of an adequate
+Added: level of commercial sales to cover expenses, we may need to secure additional funding through public or private equity or debt financings,
+Added: through collaborations or partnerships with other companies or other sources.
+Added: We may not be able to raise additional capital on terms
+Added: acceptable to us, or at all.
+Added: Any failure to raise capital when needed could compromise our ability to execute on our business plan.
+Added: we are unable to raise additional funds, or if our anticipated operating results are not achieved, we believe planned expenditures may
+Added: 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 the
+Added: necessary capital in the future from operating results or future financing, it may have a material adverse effect on our operations and
+Added: 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.
−Removed: NeuroOne Medical Technologies Corporation
The following is a summary of cash flows for each
of the periods set forth below.
−Removed: For the Three Months Ended
+Added: Six Months Ended
Net cash provided by (used in) operating activities
2 unchanged sentences
Net cash (used in) provided by financing activities
−Removed: Net decrease in cash
+Added: Net decrease in cash and cash equivalents
$ (2,887,838 )
1 unchanged sentence
Net cash provided by operating activities was
−Removed: $0.2 million for the three months ended December 31, 2024, which consisted of net income of $1.8 million inclusive of non-cash stock-based
−Removed: compensation, depreciation, amortization related to intangible assets and deferred costs, non-cash lease expense, fair value change in
−Removed: warrant liability and reclass of debt facility termination costs totaling approximately $0.4 million in the aggregate.
−Removed: The net change
−Removed: in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a net cash use of approximately
−Removed: $2.0 million.
−Removed: The net cash use stemming from the change in operating assets and liabilities was primarily attributable to an increase
−Removed: in accounts receivable in connection with the Zimmer Distribution Agreement and to a decrease in accrued expenses and accounts payable,
−Removed: offset in part by decreases in prepaid expenses and inventory on hand attributed to the timing of payments and purchases.
+Added: $152,000 for the six months ended March 31, 2025, which consisted of a net loss of $0.5 million partially offset by non-cash stock-based
+Added: compensation, depreciation, amortization related to intangible assets, a fair value change in warrant liability and operating lease expense,
+Added: totaling approximately $0.2 million in the aggregate.
+Added: Our net loss was further adjusted to account for the reclassification of debt termination
+Added: costs to financing activities in the amount of $0.1 million.
+Added: The net change in our net operating assets and liabilities associated with
+Added: fluctuations in our operating activities resulted in a cash source of approximately $0.3 million.
+Added: The net cash source stemming from the
+Added: change in operating assets and liabilities was primarily attributable to both a decrease in inventory and prepaid expenses, partially
+Added: offset by a net decrease in our aggregate accrued expenses, other liabilities and accounts payable as well as by an increase in our accounts
+Added: receivable attributed to the timing of payments.
Net cash used in operating activities was
−Removed: million for the three months ended December 31, 2023, which consisted of a net loss of $3.3 million partially offset by non-cash stock-based
−Removed: compensation, depreciation, amortization related to intangible assets and non-cash lease expense, totaling approximately $0.4 million
−Removed: in the aggregate.
−Removed: The net change in our net operating assets and liabilities associated with fluctuations in our operating activities
−Removed: resulted in a net cash use of $0.9 million.
−Removed: The net cash use stemming from the change in operating assets and liabilities was primarily
−Removed: attributable to an increase in accounts receivable in connection with the Zimmer Distribution Agreement and to a decrease in accrued expenses,
−Removed: offset in part by decreases in prepaid expenses and inventory on hand attributed to the timing of payments and purchases.
−Removed: Net cash used in investing activities
−Removed: Net cash used in investing activities for the
−Removed: three months ended December 31, 2024 was $24,000 and consisted of outlays for purchases of property and equipment.
−Removed: Net cash used in investing activities for the
−Removed: three months ended December 31, 2023 was $37,000 and consisted of outlays for purchases of property and equipment.
+Added: $6.0 million for the six months ended March 31, 2024, which consisted of a net loss of $6.2 million partially offset principally by
+Added: non-cash stock-based compensation, depreciation, amortization related to intangible assets, operating lease expense, totaling
+Added: approximately $0.8 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 approximately $0.6 million.
+Added: The net cash use stemming from the change in
+Added: operating assets and liabilities was primarily attributable to both an increase in our accounts receivable and prepaid expense as
+Added: well as attributed to a net decrease in our accrued expenses and other liabilities.
+Added: Partially offsetting the net cash used for the
+Added: period was the reduction in inventory purchases and increase in our account payable attributed to the timing of payments.
+Added: NeuroOne Medical Technologies Corporation
+Added: Net used in investing activities
+Added: Net cash used in investing activities was $28,000
+Added: for the six months ended March 31, 2025 and consisted of outlays for purchases of property and equipment.
+Added: Net cash used in investing activities was $68,000
+Added: for the six months ended March 31, 2024 and consisted of outlays for purchases of property and equipment.
Net cash (used in) provided by financing activities
Net cash used in financing activities was $0.3
−Removed: million for the three months ended December 31, 2024, which consisted of the payment of issuance costs related to the August 2024 Private
−Removed: Placement that were unpaid as of September 30, 2024, debt facility costs, and deferred issuance costs in connection with ATM.
−Removed: there were common stock repurchases for the payment of withholding taxes.
+Added: million for the six months ended March 31, 2025, which consisted of issuance costs and repurchases of common stock for the payment of
+Added: employee taxes in the amount of $0.7 million in the aggregate, offset partially by proceeds from the ATM of $0.4 million.
Net cash provided by financing activities was
−Removed: $1.2 million for the three months ended December 31, 2023, which consisted of net proceeds in connection with the ATM, offset in a small
−Removed: part by common stock repurchases for the payment of withholding taxes.
−Removed: NeuroOne Medical Technologies Corporation
+Added: $3.2 million for the six months ended March 31, 2024, which consisted of net proceeds from the ATM of $3.2 million, offset partially by
+Added: repurchases of common stock for the payment of employee taxes in the amount of $25,000.
Critical Accounting Estimates
12 unchanged sentences
“Part 1, Item 1 – Financial Statements” in this Report.
−Removed: Of these policies, the following are considered critical to an understanding
−Removed: of our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report as they require
−Removed: the application of the most subjective and the most complex judgments:
+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:
For discussion about the determination of license
8 unchanged sentences
condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.
−Removed: Fair Value of Warrant liability
−Removed: We issued warrants in connection with our August
−Removed: 2024 Private Placement.
−Removed: The warrants were classified as a liability on our balance sheet and were recorded at fair value as certain provisions
−Removed: precluded equity accounting treatment for these instruments.
−Removed: We will continue to adjust the liabilities for changes in fair value until
−Removed: the earlier of the exercise, expiration, or until such time that cash settlement or indexation provisions are no longer in effect for
−Removed: the warrants.
−Removed: For discussions about the application of fair value associated with the warrants, see “Note 9 – Stockholders’
−Removed: Equity” included in “Part 1, Item 1 – Financial Statements” in this Report.
NeuroOne Medical Technologies Corporation
+Added: Fair Value of Warrant liability
+Added: We issued warrants in connection with our
+Added: August 2024 Private Placement.
+Added: The warrants were classified as a liability on our balance sheet and were recorded at fair value as certain
+Added: provisions precluded equity accounting treatment for these instruments.
+Added: We will continue to adjust the liabilities for changes in fair
+Added: value until the earlier of the exercise, expiration, or until such time that cash settlement or indexation provisions are no longer in
+Added: effect for the warrants.
+Added: For discussions about the application of fair value associated with the warrants, see “Note 12 –
+Added: Stockholders’ Equity” included in “Part 1, Item 1 – Financial Statements” in this Report.
Income Tax Assets and Liabilities
17 unchanged sentences
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.