18 unchanged sentences
Forward-looking statements include statements about:
−Removed: our ability to maintain
−Removed: regulatory clearance of our cortical strip and grid electrode technology, our sEEG electrode technology, and our RF ablation
+Added: our ability to maintain regulatory clearance of our cortical strip and grid electrode technology, our sEEG electrode technology, and our RF ablation system;
our ability to successfully commercialize our technology in the United States;
3 unchanged sentences
the clinical utility of our cortical strip, grid and depth electrodes, RF ablation system, and technology under development;
−Removed: our ability to develop
−Removed: additional applications of our cortical strip, grid and depth electrode and RF ablation technology with the benefits we hope to
−Removed: offer as compared to existing technology, or at all;
+Added: our ability to develop additional applications of our cortical strip, grid and depth electrode and RF ablation technology with the benefits we hope to offer as compared to existing technology, or at all;
the results of our development and distribution relationship with Zimmer, Inc.
we have been the victim of a cyber-related crime, and our controls may not be successful in avoiding future cyber-related crimes;
−Removed: the performance,
−Removed: productivity, reliability and regulatory compliance of our third-party manufacturers of our cortical strip, electrode and depth
−Removed: electrode and RF ablation technology;
−Removed: our ability to develop
−Removed: future generations of our cortical strip, grid and depth electrode and RF ablation technology;
+Added: the performance, productivity, reliability and regulatory compliance of our third-party manufacturers of our cortical strip, electrode and depth electrode and RF ablation technology;
+Added: our ability to develop future generations of our cortical strip, grid and depth electrode and RF ablation technology;
our future development priorities;
our ability to obtain reimbursement coverage for our cortical strip, grid and depth electrode technology;
−Removed: NeuroOne Medical Technologies
−Removed: our expectations about the
−Removed: willingness of healthcare providers to recommend our cortical strip, grid and depth electrode and RF ablation technology to people
−Removed: with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related
−Removed: neurological disorders;
+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: NeuroOne Medical Technologies Corporation
our future commercialization, marketing and manufacturing capabilities and strategy;
1 unchanged sentence
our ability to maintain our intellectual property position;
−Removed: our expectations regarding
−Removed: international opportunities for commercializing our cortical strip, grid and depth electrode and RF ablation technology under
−Removed: including technology under development;
+Added: our expectations regarding international opportunities for commercializing our cortical strip, grid and depth electrode and RF ablation technology under including technology under development;
our estimates regarding the size of, and future growth in, the market for our technology, including technology under development;
+Added: our ability to satisfy the continued listing requirements of Nasdaq;
our estimates regarding our future expenses and needs for additional financing.
27 unchanged sentences
applications of our technology associated with artificial intelligence.
−Removed: NeuroOne has received 510(k) clearance for
−Removed: three of its devices from the FDA, including:
−Removed: (i) our Evo cortical electrode technology for recording, monitoring, and stimulating
−Removed: brain tissue for up to 30 days, (ii) our Evo sEEG electrode technology for temporary (less than 30 days) use with recording,
−Removed: monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level
−Removed: of the brain, and (iii) our OneRF ablation system for creation of radiofrequency lesions in nervous tissue for functional
−Removed: neurosurgical procedures.
−Removed: Our other products are still under development.
−Removed: NeuroOne Medical Technologies
−Removed: We commenced commercial sales of cEEG strip/grid and electrode cable
−Removed: assembly products beginning in the first quarter of fiscal year 2021.
−Removed: We sold, on a limited application basis for design verification,
−Removed: sEEG depth electrode products for non-human use beginning in late fiscal year 2021, and we commenced commercial sales of our sEEG depth
−Removed: electrode products in late calendar 2022.
−Removed: We initiated a limited commercial launch of our OneRF ablation system in March 2024.
+Added: NeuroOne has received 510(k) clearance for three
+Added: of its 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: Under the Zimmer Development Agreement, we commenced
+Added: commercial sales of cEEG strip/grid electrodes and cable assembly products beginning in the first quarter of fiscal year 2021.
+Added: on a limited application basis for design verification, sEEG depth electrode products for non-human use beginning in late fiscal year
+Added: 2021, and we commenced commercial sales of our sEEG depth electrode products in late calendar 2022.
+Added: We have also initiated a limited commercial
+Added: launch of our OneRF ablation system in March 2024 without a distribution partner.
+Added: NeuroOne Medical Technologies Corporation
We have incurred losses
since inception.
−Removed: As of March 31, 2024, we had an accumulated deficit of $68.9 million, primarily as a result of expenses incurred in connection
+Added: As of June 30, 2024, we had an accumulated deficit of $71.7 million, primarily as a result of expenses incurred in connection
with our research and development, selling, general and administrative expenses associated with our operations and interest expense, fair
22 unchanged sentences
We do not have a distribution partner for the OneRF ablation system at this time, and are continuing
−Removed: to pursue potential strategic partnerships for this product.
+Added: to pursue a potential strategic partnership for the OneRF Products.
+Added: Nasdaq Notice
+Added: Since May 28, 2024, the closing price of our common
+Added: stock has been below $1.00.
+Added: On July 11, 2024, we received a letter (the “Notice”) from the Listing Qualifications Department
+Added: (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) informing us that because the closing bid price for our common
+Added: stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company was not in compliance with the minimum bid price requirement
+Added: for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
+Added: In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from July 11, 2024, or until January
+Added: 7, 2025, to regain compliance with the Minimum Bid Price Requirement.
+Added: If at any time before January 7, 2025, the closing bid price of
+Added: the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days (which number days may
+Added: be extended by Nasdaq), Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement,
+Added: and the matter would be resolved.
+Added: The Notice also disclosed that in the event we
+Added: do not regain compliance with the Rule by January 7, 2025, we may be eligible for additional time.
+Added: To qualify for additional time, we
+Added: would be required to meet the applicable market value of publicly held shares requirement for continued listing and all other applicable
+Added: standards for initial listing on The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide
+Added: written notice of its intention to cure the deficiency during the second compliance period.
+Added: If we meet these requirements, Nasdaq will
+Added: inform us that it has been granted an additional 180 calendar days.
+Added: However, if it appears to the Staff that we will not be able to cure
+Added: the deficiency, or if we are otherwise not eligible, Nasdaq will provide notice that our securities will be subject to delisting.
+Added: We intend to continue actively monitor the closing
+Added: bid price for our common stock between now and January 7, 2025, and will consider available options to resolve the deficiency and regain
+Added: compliance with the Minimum Bid Price Requirement.
+Added: If we do not regain compliance within
+Added: the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock
+Added: will be subject to delisting.
+Added: We would then be entitled to appeal that determination to a Nasdaq hearings panel.
+Added: There can be no assurance
+Added: that we will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period, secure a second period of
+Added: 180 calendar days to regain compliance, or maintain compliance with the other Nasdaq listing requirements.
+Added: NeuroOne Medical Technologies Corporation
Global Economic Conditions
15 unchanged sentences
in fiscal and monetary policy, including increased interest rates.
−Removed: NeuroOne Medical Technologies
Financial Overview
2 unchanged sentences
of our Strip/Grid Products, sEEG Products and electrode cable assembly products (“Electrode Cable Assembly Products”) based
−Removed: on Evo cortical electrode technology.
−Removed: We anticipate that we will generate additional revenue from the sale of products based on Evo cortical
−Removed: electrode technology and our OneRF ablation system.
+Added: on Evo cortical electrode technology and products based on our OneRF ablation system (“OneRF Products”).
+Added: We anticipate that
+Added: we will generate additional revenue from the sale of products based on Evo cortical electrode technology and our OneRF ablation system.
In November 2019, we received FDA 510(k) clearance
for our cortical electrode for temporary (less than 30 days) recording, monitoring, and stimulation on the surface of the brain.
−Removed: In October 2022, we received FDA 510(k) clearance for our Evo sEEG electrode technology for temporary (less than 30 days) use with recording,
−Removed: monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of
−Removed: In December 2023, we received FDA 510(k) clearance for our OneRF ablation system for creation of radiofrequency lesions
−Removed: in nervous tissue for functional neurosurgical procedure.
+Added: 2022, we received FDA 510(k) clearance for our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring,
+Added: and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
+Added: December 2023, we received FDA 510(k) clearance for our OneRF ablation system for creation of radiofrequency lesions in nervous tissue
+Added: for functional neurosurgical procedure.
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 and outside supplier materials costs of producing the
−Removed: Electrode Cable Assembly Products.
−Removed: In addition, cost of product revenue includes royalty fees incurred in connection with our license
+Added: contract manufacturer in connection with our Strip/Grid Products, sEEG Products, OneRF Products and outside supplier materials costs of
+Added: producing the Electrode Cable Assembly Products.
+Added: In addition, cost of product revenue includes royalty fees incurred in connection with
+Added: our license agreements.
Collaborations Revenue
8 unchanged sentences
Agreement through a joint development committee composed of an equal number of representatives of Zimmer and the Company.
+Added: NeuroOne Medical Technologies Corporation
Under the terms of the Zimmer Development Agreement, we are responsible
19 unchanged sentences
$2.0 million for satisfaction of each of the milestone events related to the design of sEEG Products set forth in the Zimmer Development Agreement, even though the satisfaction was after the deadlines originally identified.
−Removed: NeuroOne Medical Technologies
In addition, in connection with the Zimmer Amendment,
32 unchanged sentences
Accordingly, we recognized
−Removed: revenue in the amount of $1.5 million during the six months ended March 31, 2023 related to the completion of the sEEG exclusivity maintenance
−Removed: There was no collaboration revenue during the six months ended March 31, 2024.
+Added: revenue in the amount of $1.5 million during the nine months ended June
+Added: 30, 2023 related to the completion of the sEEG exclusivity maintenance milestone.
+Added: There was no collaboration revenue during the nine months
+Added: ended June 30, 2024.
+Added: NeuroOne Medical Technologies Corporation
The achievement of the level of sales required
11 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 and electrode cable assembly products.
−Removed: We anticipate that our selling, general
−Removed: and administrative expenses will increase in the future to support our continued research and development activities, further commercialization
−Removed: of our cortical strip and grid technology, and our depth electrode technology, and the increased costs of operating as a public company.
−Removed: These increases will include increased costs related to the hiring of additional personnel and fees for legal and professional services,
−Removed: as well as other public company related costs.
−Removed: NeuroOne Medical Technologies
+Added: the commercial sale of cEEG strip/grid, sEEG depth electrode, OneRF ablation system and electrode cable assembly products.
+Added: We anticipate
+Added: that our selling, general and administrative expenses will increase in the future to support our continued research and development activities,
+Added: further commercialization of our cortical strip and grid technology, ablation system and our depth electrode technology, and the increased
+Added: costs of operating as a public company.
+Added: These increases will include increased costs related to the hiring of additional personnel and
+Added: fees for legal and professional services, as well as other public company related costs.
Research and Development
Research and development expenses consist of expenses
−Removed: incurred in performing research and development activities in developing our cortical strip and grid electrode and depth electrode technology.
−Removed: Research and development expenses include compensation and benefits for research and development employees including stock-based compensation,
−Removed: overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory
−Removed: operations, fees paid to consultants and other outside expenses.
−Removed: Research and development costs are expensed as incurred and costs incurred
−Removed: by third parties are expensed as the contracted work is performed.
−Removed: Lastly, de minimis income from the sale of prototype products and related
−Removed: materials are offset against research and development expenses.
+Added: incurred in performing research and development activities in developing our cortical strip, grid electrode, depth electrode and ablation
+Added: system technology.
+Added: Research and development expenses include compensation and benefits for research and development employees including
+Added: stock-based compensation, overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses,
+Added: costs related to regulatory operations, fees paid to consultants and other outside expenses.
+Added: Research and development costs are expensed
+Added: as incurred and costs incurred by third parties are expensed as the contracted work is performed.
+Added: Lastly, de minimis income from the sale
+Added: of prototype products and related materials are offset against research and development expenses.
We expect our research and development expenses
−Removed: to increase over the next several years as we develop additional applications for our electrode technology and conduct preclinical testing
−Removed: and clinical trials.
−Removed: Other Income (Expense), net
−Removed: Other income (expense), net primarily consists
−Removed: of interest income related to our cash, cash equivalents, investment income or loss from short-term investments and other income or expense
−Removed: outside of normal operating activity relating to legal settlements, sales of non-commercial supplies and other items as applicable.
+Added: to increase over the next several years as we develop additional applications for our electrode and ablation system technology and conduct
+Added: preclinical testing and clinical trials.
+Added: Other Income, net
+Added: Other income, net primarily consists of interest
+Added: income related to our cash, cash equivalents, investment income or loss from short-term investments and other income or expense outside
+Added: of normal operating activity relating to legal settlements, sales of non-commercial supplies and other items as applicable.
+Added: NeuroOne Medical Technologies Corporation
Results of Operations
−Removed: Comparison of the Three Months Ended March
+Added: Comparison of the Three Months Ended June 30,
2024 and 2023
The following table sets forth the results of
−Removed: operations for the three months ended March 31, 2024 and 2023, respectively.
+Added: operations for the three months ended June 30, 2024 and 2023, respectively.
Three Months Ended
7 unchanged sentences
Loss from operations
−Removed: Other income (expense), net
+Added: Other income, net
Loss before income taxes
3 unchanged sentences
Product Revenue and Product Gross Profit
−Removed: Product revenue and product gross profit was $1.4
−Removed: million and $0.4 million, respectively, during the three months ended March 31, 2024.
−Removed: Product revenue and product gross profit was $0.5
−Removed: million and $32,000, respectively, during the three months ended March 31, 2023.
−Removed: The product revenue consists of the sale of our strip/grid,
−Removed: sEEG and electrode cable assembly products.
−Removed: Cost of product revenue consisted of the manufacturing and materials costs incurred by our
−Removed: third-party contract manufacturer in connection with our strip/grid and sEEG products, and outside supplier materials costs in connection
+Added: Product revenue was $0.8 million during the three
+Added: months ended June 30, 2024 with a gross margin and gross profit percentage of $0.3 million and 34.1%, respectively.
+Added: During the three months
+Added: ended June 30, 2023, product revenue was $0.6 million with a gross margin and gross profit percentage of $0.2 million and 38.7%, respectively.
+Added: The decrease in the gross profit percentage in the current period when compared to the corresponding prior year period was primarily due
+Added: to an increase in material supply costs.
+Added: Product revenue consisted of the sale of our Strip/Grid Products, sEEG Products, OneRF Products
+Added: and Electrode Cable Assembly Products.
+Added: Cost of product revenue consisted of the manufacturing and materials costs incurred by our third-party
+Added: contract manufacturer in connection with our Strip/Grid, sEEG Products and OneRF Products, and outside supplier materials costs in connection
with the Electrode Cable Assembly Products.
In addition, cost of product revenue included royalty fees incurred of approximately $38,000
−Removed: and $38,000 in connection with our license agreements during the three months ended March 31, 2024 and 2023, respectively.
−Removed: NeuroOne Medical Technologies
−Removed: Selling, General and Administrative Expenses
+Added: and $43,000 in connection with our license agreements during the three months ended June 30, 2024 and 2023, respectively.
Selling, General and Administrative Expenses
−Removed: were $2.0 and $1.8 million during the three months ended March 31, 2024 and 2023, respectively.
−Removed: The $0.2 million expense increase in
−Removed: the current quarter over the comparable prior year quarter was attributed to higher administrative payroll of $0.2 million and stock-based
−Removed: compensation of $0.1 million, partially offset by lower professional services and marketing expenses of $0.1 million.
−Removed: Selling, general
−Removed: and administrative expenses included $0.3 million and $0.2 million of stock-based compensation during the three months ended March 31,
−Removed: 2024 and 2023, respectively.
+Added: Selling, general and administrative expenses were
+Added: $1.9 million during each of the three months ended June 30, 2024 and 2023.
+Added: The negligible increase in costs during the current three-month
+Added: period was attributed to higher administrative payroll costs of approximately $0.1 million offset largely by professional service costs
+Added: which decreased by approximately $0.1 million.
Research and Development Expenses
Research and development expenses were $1.2 million
−Removed: for the three months ended March 31, 2024, compared to $1.7 million during for the three months ended March 31, 2023.
−Removed: The $0.4 million
−Removed: decrease in the current period over the prior year period was attributed largely to the timing and overall lower OneRF Product development
−Removed: activities in the current quarter when compared to the comparable prior year quarter.
−Removed: Research and development expenses primarily included
−Removed: salary-related expenses and costs related to consulting services, materials and supplies associated with the development of sEEG Products
−Removed: and to a much lesser extent Strip/Grid Products.
−Removed: Research and development expenses included $76,000 and $38,000 of stock-based compensation
−Removed: during the three months ended March 31, 2024 and 2023, respectively.
−Removed: Other Income (expense), net
−Removed: Other income during the three months ended March
−Removed: 31, 2024 and 2023 related to interest income on our cash, cash equivalents and short-term investments in the amount of $31,000 and $67,000,
−Removed: respectively.
−Removed: Other expense during the three months ended March
−Removed: 31, 2023 was attributed to an exploit loss of $94,000.
−Removed: There were no other expenses during the three months ended March 31, 2024.
−Removed: Comparison of the Six Months Ended March 31,
+Added: for the three months ended June 30, 2024, compared to $1.9 million during for the three months ended June 30, 2023.
+Added: The $0.7 million decrease
+Added: period over period was attributed to the net reduction in development activities associated with our sEEG Products, Strip/Grid Products
+Added: and OneRF Products given the commercialization of these products.
+Added: Activity associated with new technology development partially offset
+Added: the overall net decrease in research and development costs during the current period.
+Added: Development activities primarily included salary-related
+Added: expenses and costs related to consulting services, materials and supplies.
+Added: NeuroOne Medical Technologies Corporation
+Added: Other Income, net
+Added: Other income during the three months ended June
+Added: 30, 2024 and 2023 related to interest income on our cash and cash equivalents in the amount of $26,000 and $41,000, respectively.
+Added: Comparison of the Nine Months Ended June 30,
2024 and 2023
The following table sets forth the results of
−Removed: operations for the six months ended March 31, 2024 and 2023, respectively.
−Removed: Six Months Ended
+Added: operations for the nine months ended June 30, 2024 and 2023, respectively.
+Added: Nine Months Ended
Product revenue
12 unchanged sentences
$ (8,724,370 )
−Removed: NeuroOne Medical Technologies
Product Revenue and Product Gross Profit
−Removed: Product revenue and product gross profit was $2.4
−Removed: million and $0.7 million during the six months ended March 31, 2024, respectively.
−Removed: Product revenue and product gross profit was $0.6 million
−Removed: and $19,000 during the six months ended March 31, 2023, respectively.
+Added: Product revenue was $3.2 million during the nine
+Added: months ended June 30, 2024 with a gross profit and gross profit percentage of $0.9 million and 29.5%, respectively.
+Added: Product revenue was
+Added: $1.2 million during the nine months ended June 30, 2023 with a gross margin and gross profit percentage of $0.3 million and 21.7%, respectively.
+Added: The increase in gross profit percentage during the current period was largely due to the higher sales volume that exceeded fixed royalty
+Added: period costs and due to slightly lower overall material supply costs.
Product revenue consisted of Strip/Grid Products, sEEG Products,
−Removed: and Electrode Cable Assembly Products sales.
−Removed: Cost of product revenue consisted of the manufacturing and materials costs incurred by our
−Removed: third-party contract manufacturer in connection with our Strip/Grid Products, sEEG Products and outside supplier materials costs in connection
−Removed: with the Electrode Cable Assembly Products.
−Removed: In addition, cost of product revenue included royalty fees incurred of approximately $79,000
−Removed: and $76,000 in connection with our license agreements during the six months ended March 31, 2024 and 2023, respectively.
+Added: OneRF Products and Electrode Cable Assembly Products sales.
+Added: Cost of product revenue consisted of the manufacturing and materials costs
+Added: incurred by our third-party contract manufacturer 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 $117,000 and $119,000 in connection with our license agreements during the nine months ended June 30, 2024
+Added: and 2023, respectively.
Collaborations Revenue
−Removed: Collaborations revenue was zero and $1.5 million
−Removed: for the six months ended March 31, 2024 and 2023, respectively.
−Removed: Revenue was derived from the Zimmer Development Agreement and represented
−Removed: the portion of the upfront initial development fee payment eligible for revenue recognition during such period.
−Removed: The amount of revenue
−Removed: recognized in the current six months related to the completion of the sEEG maintenance fee obligation as a result of securing FDA approval.
−Removed: For the comparable prior year period, the upfront fee was based on development completed in connection with depth electrode products,
−Removed: and to a lesser extent, the strip/grid products.
+Added: Collaborations revenue was $1.5 million for the
+Added: nine months ended June 30, 2023.
+Added: Revenue during the period was derived from the Zimmer Development Agreement in connection with the completion
+Added: of the sEEG maintenance fee obligation as a result of securing FDA approval.
+Added: There was no collaborations revenue during the nine months
+Added: ended June 30, 2024.
+Added: NeuroOne Medical Technologies Corporation
Selling, General and Administrative Expenses
Selling, general and administrative expenses were
−Removed: $4.2 million for the six months ended March 31, 2024, compared to $3.5 million for the six months ended March 31, 2023.
+Added: $6.1 million for the nine months ended June 30, 2024, compared to $5.3 million for the nine months ended June 30, 2023.
The $0.7 million
−Removed: increase in the current six month period compared to the comparable prior year period was primarily due to higher administrative payroll
−Removed: of $0.3 million, professional fees of $0.3 million, mainly in connection with legal services, and other general operating expenses of
−Removed: $0.1 million on a net basis.
−Removed: Selling, general and administrative expenses included $0.5 million of stock-based compensation during each
−Removed: of the six months ended March 31, 2024 and 2023.
+Added: increase during the current period was primarily attributed to higher administrative payroll costs of $0.4 million, professional services
+Added: of $0.2 million and sales and marketing costs of $0.1 million.
Research and Development Expenses
Research and development expenses were $4.0 million
−Removed: for the six months ended March 31, 2024, compared to $3.3 million for the six months ended March 31, 2023.
+Added: for the nine months ended June 30, 2024, compared to $5.2 million for the nine months ended June 30, 2023.
The $1.2 million decrease period
−Removed: over period was attributed to the timing and an overall reduction in supporting OneRF development activities during the current six month
−Removed: period when compared to the comparable prior year period.
−Removed: Research and development primarily included salary-related expenses and costs
−Removed: related to consulting services, materials and supplies associated with the development of sEEG Products and to a much lesser extent Strip/Grid
−Removed: Research and development expenses included $142,000 and $83,000 of stock-based compensation during the six months ended March
−Removed: 31, 2024 and 2023, respectively,
+Added: over period was attributed to the net reduction in development activities associated with our sEEG Products, Strip/Grid Products and OneRF
+Added: Products given the commercialization of these products.
+Added: Activity associated with new technology development partially offset the overall
+Added: net decrease in research and development costs during the current period.
+Added: Development activities primarily included salary-related expenses
+Added: and costs related to consulting services, materials and supplies.
Other Income, net
−Removed: Other income, net during the six months ended
−Removed: March 31, 2024 consisted of $77,000 related to interest income attributed to our cash and cash equivalents.
−Removed: Other income, net during the six months ended
−Removed: March 31, 2023 consisted of $119,000 related primarily to interest income attributed to our cash, cash equivalents and short-term investments,
−Removed: partially offset by an exploit loss of $94,000.
−Removed: NeuroOne Medical Technologies
+Added: Other income, net during the nine months ended
+Added: June 30, 2024 of $0.1 million consisted of interest income attributed to our cash and cash equivalents.
+Added: Other income, net during the nine months ended June 30, 2023 of $66,000
+Added: consisted of $160,000 related primarily to interest income attributed to our cash, cash equivalents and short-term investments, while
+Added: outstanding, which was partially offset by an exploit loss of $94,000.
Liquidity and Capital Resources
−Removed: As of March 31, 2024, our principal source of
−Removed: liquidity consisted of cash and cash equivalents in the aggregate of approximately $2.4 million.
−Removed: While we began to generate revenue in
−Removed: 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 and our royalty obligations under our intellectual property licenses with the Wisconsin
−Removed: Alumni Research Foundation (“WARF”) and the Mayo Foundation for Medical Education and Research (“Mayo”).
−Removed: additional material cash needs include commitments under operating leases and other administrative services.
−Removed: See “Funding Requirements”
−Removed: below for more information.
−Removed: We anticipate that our expenses will increase substantially as we develop and commercialize our electrode
−Removed: technology and pursue pre-clinical and clinical trials, seek regulatory approvals, manufacture products, establish our own sales, marketing
−Removed: and distribution infrastructure to commercialize our ablation electrode technology, hire additional staff, add operational, financial
−Removed: and management systems and continue to operate as a public company.
+Added: As of June 30, 2024, our principal source of liquidity
+Added: consisted of cash and cash equivalents in the aggregate of approximately $1.6 million.
+Added: While we began to generate revenue in fiscal year
+Added: 2021 from commercial sales and through milestone and other payments under our collaboration with Zimmer, we expect to continue to incur
+Added: significant expenses and increasing operating and net losses for the foreseeable future until and unless we generate an adequate level
+Added: of revenue from commercial sales to cover expenses.
+Added: Our most significant cash requirements relate to the funding of our ongoing product
+Added: development and commercialization operations.
+Added: Our additional material cash needs include commitments under operating leases, royalty obligations
+Added: under our intellectual property licenses with the Wisconsin Alumni Research Foundation (“WARF”) and the Mayo Foundation for
+Added: Medical Education and Research (“Mayo”) as well as other administrative services.
+Added: See “Funding Requirements” below
+Added: for more information.
+Added: We anticipate that our expenses will increase substantially as we continue to develop and commercialize our electrode
+Added: technology and pursue pre-clinical and clinical trials, seek regulatory approvals, manufacture products, market and distribute our OneRF
+Added: Products, hire additional staff, add operational, financial and management systems and continue to operate as a public company.
+Added: 2, 2024, we closed a private placement of shares of common stock and warrants for total gross proceeds of approximately $2.65 million,
+Added: and entered into a delayed draw term loan facility in an aggregate principal amount not to exceed $3.0 million.
Capital Resources
7 unchanged sentences
price of up to $14.5 million.
−Removed: JonesTrading is entitled to a commission at a fixed commission rate of up to 3% of the gross proceeds.
−Removed: On July 24, 2023, we decreased the amount of common stock that can be sold pursuant to the Sales Agreement, such that we were offering
−Removed: up to an aggregate of $2.6 million of our common stock for sale under the Sales Agreement, including the shares of common stock previously
−Removed: Subsequently on December 1, 2023, however, we increased the amount of common stock that can be sold pursuant to the Sales Agreement,
−Removed: such that we were offering up to an aggregate of $4.8 million of our common stock for sale under the Sales Agreement, including the shares
−Removed: of common stock previously sold.
−Removed: On January 5, 2024, we further increased the amount of common stock that can be sold pursuant to
−Removed: the Sales Agreement, such that we are offering up to an aggregate of $9.3 million of our common stock for sale under the Sales Agreement,
−Removed: including the shares of common stock previously sold.
−Removed: Through March 31, 2024, we have issued 3,769,273
+Added: JonesTrading is entitled to a commission at a fixed commission
+Added: rate of up to 3% of the gross proceeds.
+Added: On July 24, 2023, we decreased the amount of common stock that can be sold pursuant to the Sales
+Added: Agreement, such that we were offering up to an aggregate of $2.6 million of our common stock for sale under the Sales Agreement, including
+Added: the shares of common stock previously sold.
+Added: Subsequently on December 1, 2023, however, we increased the amount of common stock that can
+Added: be sold pursuant to the Sales Agreement, such that we were offering up to an aggregate of $4.8 million of our common stock for sale under
+Added: the Sales Agreement, including the shares of common stock previously sold.
+Added: On January 5, 2024, we further increased the amount of
+Added: common stock that can be sold pursuant to the Sales Agreement, such that we are offering up to an aggregate of $9.3 million of our common
+Added: stock for sale under the Sales Agreement, including the shares of common stock previously sold.
+Added: NeuroOne Medical Technologies Corporation
+Added: Through June 30, 2024, we have issued 5,188,590
shares of common stock under the ATM for gross proceeds in the amount of $7.6 million.
We incurred issuance costs in connection with the
−Removed: ATM in the amount of $0.4 million through March 31, 2024.
−Removed: Between April 1 and May 10, 2024, we issued an additional 1,093,135 shares of
−Removed: common stock for net proceeds in the amount of $1.3 million in connection with the Sales Agreement.
−Removed: NeuroOne Medical Technologies
+Added: ATM in the amount of $0.5 million through June 30, 2024.
July 2023 Public Offering
36 unchanged sentences
Refer to “Note 4 – Commitments and Contingencies” included in our condensed
−Removed: financial statements included in “Part 1, Item 1 – Financial Statements” in this Report for further detail of our lease
−Removed: obligations and the timing of expected future payments.
−Removed: Contracted services include agreements with third-party service providers
−Removed: for clinical research, product development, manufacturing, supplies, payroll services, equipment maintenance services, and audits for
−Removed: periods up to fiscal year 2025.
+Added: financial statements included in “Part 1, Item 1 – Financial Statements”
+Added: in this Report for further detail of our lease obligations and the timing of expected future payments.
+Added: Contracted services include agreements
+Added: with third-party service providers for clinical research, product development, manufacturing, supplies, payroll services, equipment maintenance
+Added: services, and audits for periods up to fiscal year 2028.
+Added: NeuroOne Medical Technologies Corporation
We expect to satisfy
1 unchanged sentence
to cover expenses, if ever, from future equity and debt financings.
−Removed: NeuroOne Medical Technologies
Liquidity Outlook
3 unchanged sentences
Even though we have received regulatory clearance to expand the use of our Evo sEEG electrode technology for up to 30 days, commercial
−Removed: sales of the sEEG electrodes are expected to take some time to be a significant source of liquidity.
−Removed: Zimmer has exclusive global rights
−Removed: to distribute our strip and grid cortical electrodes, depth electrodes and electrode cable assembly products.
−Removed: Zimmer’s failure to
−Removed: timely develop or commercialize these products would have a material adverse effect on our business and operating results.
−Removed: At March 31, 2024, we had cash and cash equivalents
+Added: sales of the sEEG electrodes and OneRF Products are expected to take some time to be a significant source of liquidity.
+Added: Zimmer has exclusive
+Added: global rights to distribute our strip and grid cortical electrodes, depth electrodes and electrode cable assembly products.
+Added: failure to timely develop or commercialize these products would have a material adverse effect on our business and operating results.
+Added: We do not have a distribution partner for the OneRF ablation system at this time, and are continuing to pursue a potential strategic partnership
+Added: for the OneRF Products.
+Added: At June 30, 2024, we had cash and cash equivalents
in the aggregate of approximately $1.6 million.
16 unchanged sentences
The development and commercialization of our cortical
−Removed: strip, grid electrode and depth electrode technology is subject to numerous uncertainties, and we could use our cash and cash equivalent
−Removed: resources sooner than we expect.
−Removed: Additionally, the process of developing medical devices is costly, and the timing of progress in pre-clinical
−Removed: tests and clinical trials is uncertain.
−Removed: Our ability to successfully transition to profitability will be dependent upon achieving further
−Removed: regulatory approvals and achieving a level of product sales adequate to support our cost structure.
−Removed: We cannot assure you that we will
−Removed: ever be profitable or generate positive cash flow from operating activities.
+Added: strip, grid electrode, depth electrode and ablation system technology is subject to numerous uncertainties, and we could use our cash
+Added: and cash equivalent resources sooner than we expect.
+Added: Additionally, the process of developing medical devices is costly, and the timing
+Added: of progress in pre-clinical tests and clinical trials is uncertain.
+Added: Our ability to successfully transition to profitability will be dependent
+Added: upon achieving further regulatory approvals and achieving a level of product sales adequate to support our cost structure.
+Added: We cannot assure
+Added: you that we will ever be profitable or generate positive cash flow from operating activities.
The following is a summary of cash flows for each
of the periods set forth below.
−Removed: Six Months Ended
+Added: Nine Months Ended
Net cash used in operating activities
6 unchanged sentences
$ (5,076,871 )
+Added: NeuroOne Medical Technologies Corporation
Net cash used in operating activities
Net cash used in operating activities was $8.3
−Removed: million for the six months ended March 31, 2024, which consisted of a net loss of $6.2 million partially offset principally by non-cash
+Added: million for the nine months ended June 30, 2024, which consisted of a net loss of $9.0 million partially offset principally by non-cash
stock-based compensation, depreciation, amortization related to intangible assets, operating lease expense, totaling approximately $1.3
3 unchanged sentences
The net cash use stemming from the change in operating assets and liabilities was
−Removed: primarily attributable to both an increase in our accounts receivable and prepaid expense as well as attributed to a net decrease in our
−Removed: accrued expenses and other liabilities.
−Removed: Partially offsetting the net cash used for the period was the reduction in inventory purchases
−Removed: and increase in our account payable attributed to the timing of payments.
−Removed: NeuroOne Medical Technologies
+Added: primarily attributable to both an increase in our accounts receivable and inventory purchases.
Net cash used in operating activities was $10.0
−Removed: million for the six months ended March 31, 2023, which consisted of a net loss of $5.3 million partially offset principally by non-cash
−Removed: stock-based compensation, depreciation, amortization related to intangible assets and to our short-term investments, operating lease expense,
−Removed: totaling approximately $0.6 million in the aggregate.
−Removed: The net change in our net operating assets and liabilities associated with fluctuations
−Removed: 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
−Removed: assets and liabilities was primarily attributable to a decrease in deferred revenue in connection with the completion of the remaining
−Removed: milestone performance obligation under the Zimmer Development Agreement, and to a lesser extent, to an increase in inventory purchases,
−Removed: accounts receivable and prepaids, coupled with a decrease in the aggregate of account payable and accrued expenses, attributed to the
−Removed: timing of payments.
+Added: million for the nine months ended June 30, 2023, which consisted of a net loss of $8.7 million partially offset principally by non-cash
+Added: stock-based compensation, depreciation, amortization related to intangible assets, operating lease expense, totaling approximately $1.0
+Added: million in the aggregate.
+Added: The net change in our net operating assets and liabilities associated with fluctuations in our operating activities
+Added: resulted in a cash use of approximately $2.3 million.
+Added: The net cash use stemming from the change in operating assets and liabilities was
+Added: primarily attributable to a decrease in deferred revenue in connection with the completion of the remaining milestone performance obligation
+Added: under the Zimmer Development Agreement, and to a lesser extent, to an increase in inventory purchases, coupled with a decrease in the
+Added: aggregate of account payable and accrued expenses, attributed to the timing of payments.
+Added: Partially offsetting the net cash operating use
+Added: during the period was a decrease in our accounts receivable and prepaids in the aggregate of $0.1 million resulting from timing of payments
+Added: and fluctuations in our operations.
Net cash (used in) provided by investing activities
Net cash used in investing activities was $0.1
−Removed: for the six months ended March 31, 2024 and consisted of outlays for purchases of property and equipment.
+Added: million for the nine months ended June 30, 2024 and consisted of outlays for purchases of property and equipment.
Net cash provided by investing activities was
−Removed: $1.8 million for the six months ended March 31, 2023 and consisted of maturities of short-term investments in the amount of $3.5 million,
+Added: $2.7 million for the nine months ended June 30, 2023 and consisted of maturities of short-term investments in the amount of $4.5 million,
offset by purchases of short term investment of $1.5 million, consisting of treasury and corporate notes.
3 unchanged sentences
Net cash provided by financing activities was
−Removed: $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
−Removed: repurchases of common stock for the payment of employee taxes in the amount of $25,000.
+Added: $4.7 million for the nine months ended June 30, 2024, which consisted of net proceeds from the ATM of $4.8 million, offset partially by
+Added: repurchases of common stock for the payment of employee taxes in the amount of $0.1 million.
Net cash provided by financing activities was
−Removed: $0.6 million for the six months ended March 31, 2023, which consisted of net proceeds from the ATM of $0.7 million, offset partially by
+Added: $2.2 million for the nine months ended June 30, 2023, which consisted of net proceeds 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 million.
13 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: NeuroOne Medical Technologies Corporation
+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 collaborations
4 unchanged sentences
and sales returns.
−Removed: NeuroOne Medical Technologies
Stock-based Compensation
15 unchanged sentences
Recent Accounting Pronouncements
−Removed: Refer to “Note 3— Summary of
−Removed: Significant Accounting Policies” to our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
+Added: Refer to “Note 3— Summary of Significant
+Added: Accounting Policies” to our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
in this Report for a discussion of recently issued accounting pronouncements.
2 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.