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NeuroOne® Reports Second Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update

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EDEN PRAIRIE, Minn., May 11, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces its operating results for the fiscal second quarter 2023 ended March 31, 2023.

Fiscal Second Quarter 2023 and Recent Business Updates

Evo® sEEG:

  • Announced the commercial launch of the Evo sEEG electrode product line in the United States with exclusive distribution partner Zimmer Biomet. The new technology potentially provides NeuroOne with a new revenue stream.
  • The first clinical case using the Evo® sEEG electrode was performed at the Mayo Clinic using a stereotactic frame system. Another procedure using the Evo® sEEG electrode in robotic neurosurgery was performed at a different medical facility. This procedure was the first to utilize NeuroOne’s Evo sEEG electrode with Zimmer Biomet’s ROSA One® Brain, a robotic platform that assists surgeons in planning and performing complex yet minimally invasive neurosurgical procedures.
  • Fulfilled five shipments of sEEG product to Zimmer Biomet in preparation for launch.
  • Completed initial training for the sEEG product line to select Zimmer Biomet sales personnel.
  • Presented the Evo sEEG system alongside Zimmer Biomet at the American Association of Neurological Surgeons (AANS) annual meeting.

OneRFAblation:

  • Successfully completed usability testing for OneRF with 15 neurosurgeons.
  • Successfully completed execution of internal device verification and validation protocols for the final OneRF Ablation System.

Spinal Cord Stimulation Program:

  • Successfully completed an initial animal implant of novel thin film paddle leads for spinal cord stimulation (SCS). The devices are intended for the treatment of patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back, and leg pain. A percutaneous (through a needle) delivery system for paddle leads is also under development and has been successfully bench-tested.

Drug Delivery Program:

  • Successfully completed feasibility bench top testing of first drug delivery and recording system prototype.

Other Updates:

  • Expanded IP portfolio with new U.S. patent titled “Improved Neural Depth Probes and Related Systems and Methods” focused on a layered thin film neural depth electrode. The electrode could have potential applications in a wide variety of neurological procedures for both diagnostic and therapeutic use.
  • Expanded management team with the appointment of Anthony Millar as Vice-President of Operations.
  • Oral presentation delivered at the North American Neuromodulation Society (NANS) annual meeting titled “Electrochemical Characterization of the First FDA-Cleared Thin-Film Electrodes for Recording and Stimulation of Brain Activity.”

Dave Rosa, CEO of NeuroOne, commented, “We were excited to officially announce the commercial release of our Evo sEEG electrode and look forward to a successful launch with Zimmer Biomet. In addition, we continued to make critical progress with the OneRF ablation system design verification testing and remain on track to submit a 510(k) to FDA for OneRF in the second calendar quarter of 2023. We made meaningful progress with our spinal cord stimulation program, as well as our recording and drug delivery system. We also filled a key executive role and are excited to have Anthony Millar join our team as our VP of Operations.”

Upcoming Targeted Milestones

Evo sEEG:

  • Successful market launch of Evo sEEG system.
  • Expand sales training of the sEEG product line to Zimmer personnel.

OneRF:

  • Complete design verification and validation testing for OneRF confirming that the full feature system meets its design specifications and is fully functional.
  • Submit a 510(k) application to the FDA for OneRF ablation system in the second quarter of calendar year 2023.
  • Initiate transfer of OneRF to production activities.
  • Perform in vivo animal study with six neurosurgeons utilizing the complete OneRF ablation system.
  • Presentation of OneRF® Ablation System preclinical study at Neurological Disorders Summit (NDS-2023) Italy, June 2023.

SCS Program:

  • Complete bench top testing of percutaneous implantation of thin film paddle electrode in spinal cord model by a physician.
  • Complete first animal study to assess biocompatibility of NeuroOne’s thin film electrode in the spinal cord.

Drug Delivery Program:

  • Complete testing of drug delivery and recordings in a small animal model.

Fiscal Second Quarter 2023 Financial Results

Product revenue was $466,000 in the fiscal second quarter 2023, compared to product revenue of $37,000 in the fiscal second quarter 2022. For the first six months of fiscal 2023, product revenue was $581,000, compared to $70,000 for the same period in fiscal 2022. Collaboration revenue was $1.46 million in the first six months of fiscal 2023, compared to collaboration revenue of $6,000 in the first six months of fiscal 2022. Collaboration revenue was derived from the Zimmer Development Agreement and represents the portion of the exclusivity and milestone fee payments eligible for revenue recognition during the respective periods.

Total operating expenses in the fiscal second quarter 2023 were $3.5 million, compared with $3.0 million in the same period of the prior fiscal year. Research and Development expense in the fiscal second quarter 2023 was $1.7 million compared with $1.2 million in the same period of fiscal 2022. Selling General and Administrative expense in the fiscal second quarter 2023 was $1.8 million compared with $1.8 million in the prior year period. For the first six months of fiscal 2023, total operating expenses were $6.8 million, compared with $5.8 million in the same period of the prior fiscal year. R&D expense in the first six months of fiscal 2023 was $3.3 million compared with $2.3 million in the same period of fiscal 2022. SG&A expense in the first six months of fiscal 2023 was $3.5 million compared with $3.6 million in the prior year period.

Net loss was $3.5 million for the fiscal second quarter 2023, compared to a net loss of $3.1 million in the prior year period. Net loss for the first six months of fiscal 2023 was $5.3 million compared with $5.9 million in the same period of fiscal 2022.

As of March 31, 2023, the Company had cash, cash equivalents, and short-term investments of $4.6 million, compared to $11.1 million as of September 30, 2022. The Company had working capital of $4.8 million as of March 31, 2023, compared to working capital of $9.1 million as of September 30, 2022.

The Company had no debt outstanding as of March 31, 2023.

Conference Call and Webcast Information

Thursday, May 11, 2023 – 4:30 PM Eastern Time

Participant Dial-In:
877-405-1216 / 201-689-8336

Participant Dial-In:
888-645-4404 / 862-298-0702

Live Webcast: 
Join here.

Phone Replay:
877-660-6853 / 201-612-7415, Access ID: 13738525; available through May 25, 2023

Webcast Replay:
Available for 12 months

About NeuroOne

NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit nmtc1.com

Forward Looking Statements

This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this presentation may be a forward–looking statement that reflects NeuroOne’s current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward–looking statements by the words or phrases “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue, “focused on,” “committed to” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding the development of the Company’s electrode technology program, applications for, or receipt of, regulatory clearance, the timing and extent of product launch and commercialization of our technology, receipt of revenues from sale of the sEEG electrodes, timing and success of any clinical and pre-clinical testing, development of our OneRF, SCS and drug delivery programs, business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that the partnership with Zimmer Biomet may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages, the impact of COVID-19 or otherwise; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company’s capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks relate to clinical trial patient enrollment and the results of clinical trials; that we may be unable to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Contact:
800-631-4030
[email protected]

NeuroOne Medical Technologies Corporation 
Condensed Balance Sheets
(unaudited)

    March 31,
2023
    September 30,
2022
 
Assets            
Current assets:            
Cash and cash equivalents   $ 3,602,163     $ 8,160,329  
Short-term investments     995,432       2,981,010  
Accounts receivable     213,952       33,237  
Inventory     1,174,307       704,538  
Prepaids     370,703       296,649  
Total current assets     6,356,557       12,175,763  
Intangible assets, net     100,734       111,892  
Right-of-use asset     225,005       181,355  
Property and equipment, net     522,810       353,599  
Total assets   $ 7,205,106     $ 12,822,609  
                 
Liabilities and Stockholders’ Equity                
Current liabilities:                
Accounts payable   $ 953,446     $ 927,662  
Accrued expenses and other liabilities     596,940       715,839  
Deferred revenue           1,455,188  
Total current liabilities     1,550,386       3,098,689  
Operating lease liability, long term     121,896       119,556  
Total liabilities     1,672,282       3,218,245  
                 
Commitments and contingencies (Note 4)                
                 
Stockholders’ equity:                
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of March 31, 2023 and September 30, 2022; no shares issued or outstanding as of March 31, 2023 and September 30, 2022.            
Common stock, $0.001 par value; 100,000,000 shares authorized as of March 31, 2023 and September 30, 2022; 16,887,738 and 16,216,540 shares issued and outstanding as of March 31, 2023 and September 30, 2022, respectively.     16,888       16,217  
Additional paid–in capital     61,598,345       60,414,959  
Accumulated deficit     (56,082,409 )     (50,826,812 )
Total stockholders’ equity     5,532,824       9,604,364  
Total liabilities and stockholders’ equity   $ 7,205,106     $ 12,822,609  

See accompanying notes to condensed financial statements


NeuroOne Medical Technologies Corporation

Condensed Statements of Operations
(unaudited)

    For the
Three Months Ended
    For the
Six Months Ended
 
    March 31,     March 31,  
    2023     2022     2023     2022  
Product revenue   $ 466,176     $ 36,584     $ 580,755     $ 70,332  
Cost of product revenue     434,673       72,807       561,559       119,651  
Product gross profit (loss)     31,503       (36,223     19,196       (49,319
                                 
Collaborations revenue                 1,455,188       6,374  
                                 
Operating expenses:                                
Selling, general and administrative     1,821,108       1,818,207       3,484,845       3,560,348  
Research and development     1,706,314       1,205,380       3,269,810       2,265,842  
Total operating expenses     3,527,422       3,023,587       6,754,655       5,826,190  
Loss from operations     (3,495,919 )     (3,059,810 )     (5,280,271 )     (5,869,135 )
Other (expense) income, net     (26,909     1,743       24,674       3,593  
Loss before income taxes     (3,522,828 )     (3,058,067 )     (5,255,597 )     (5,865,542 )
Provision for income taxes                        
Net loss   $ (3,522,828 )   $ (3,058,067 )   $ (5,255,597 )   $ (5,865,542 )
                                 
Net loss per share:                                
Basic and diluted   $ (0.21 )   $ (0.19 )   $ (0.32 )   $ (0.37 )
Number of shares used in per share calculations:                                
Basic and diluted     16,414,795       16,189,867       16,321,891       15,794,880  

See accompanying notes to condensed financial statements

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Confluence former executive joins fintech Premialab

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James Carrington, a former executive at Confluence, Investment Metrics, Style Analytics has joined fintech Premialab. He brings extensive client engagement expertise in investment analytics and data for the institutional investment community.
LONDON, Feb. 27, 2024 /PRNewswire/ — Premialab, the financial data and analytics firm, announced today the appointment of James Carrington as Head of Client Engagement. Mr. Carrington, based in London, will spearhead global client engagement, leveraging over 10 years of experience in driving client engagement gained at Investment Metrics, Style Analytics, and most recently at Confluence, part of the Clearlake Capital Group portfolio. His primary focus will be on enabling faster tailor-made investment analytics delivery and data integration for Premialab’s pension funds, foundations, endowments, and insurance clients.

Adrien Geliot, Co-Founder & Chief Executive Officer of Premialab, said, “I am delighted to welcome James to the team. His appointment confirms our commitment to delivering first-class service to our customers across global locations. His experience in maximizing the value derived from investment analytics will be invaluable in serving our clients as we continue scaling our activities worldwide.”
Commenting on his appointment, James Carrington said, “I am delighted to have joined the Premialab team. Their innovative solution makes a real difference to institutional investors looking at quant investments. The evolution of Premialab over the last number of years has been something that I have followed closely, and I am looking forward to working with the team to further support our customer base across our established and emerging demographics.”
The announcement follows recent senior appointments at Premialab, including Philippe Jacson, former BNP Paribas, Merrill Lynch and MSCI executive; Daniel Fields, former Global Head of Markets at Societe Generale; John Macpherson, former Managing Director at Goldman Sachs, Citibank, and Nomura; Marc Fisher, former Managing Director at Citibank with a prior position at Deutsche Bank; and Georgios Sittas, former Managing Director at HSBC, Standard Chartered, and previously a director at Lehman Brothers.
Recognized as the reference for data and risk analytics on quantitative strategies, Premialab’s capital markets infrastructure is currently used by leading asset managers, insurance companies and pensions funds, accelerating their digitalization and enhancing performance and risk control while reducing costs. The platform’s client AUM is representing an estimated USD$10 trillion.
About Premialab
Premialab is an independent platform providing data, analytics and risk solutions on systematic and factor-based strategies in collaboration with leading investment banks and institutional investors globally. Combining intelligent technology with a unique source of information the platform empowers asset allocators to make better investment decisions whilst achieving utmost time and cost efficiency.
With offices in London, Paris, New York, Hong Kong, Sydney, and Dubai, its international team is dedicated to supporting a global client base with the most up-to-date risk premia dataset, advanced portfolio construction, performance and risk analytics. The firm has established strong partnerships with the top 18 investments banks, global asset managers, pensions funds and insurance companies.

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Axon Technologies and Keyrus Announce Strategic Partnership to Elevate Cybersecurity Business

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Keyrus Acquires Minority Stake in Axon Technologies, adding Axon’s Cybersecurity Portfolio to Keyrus Solutions, and Expanding Keyrus Reach across Middle East and Africa
PARIS and DUBAI, UAE, Feb. 27, 2024 /PRNewswire/ — In a significant development in the cybersecurity sector, Keyrus, an international leader in data intelligence and digital transformation, has announced the acquisition of a minority stake in Axon Technologies, a premier provider of cybersecurity services based in Dubai, UAE. This strategic investment marks a major milestone in Keyrus’ cybersecurity strategy, signalling an ambitious step towards establishing a global cybersecurity powerhouse.

Strategic Expansion and Enhanced Cybersecurity Solutions
The collaboration between Keyrus and Axon Technologies is set to revolutionize the cybersecurity landscape in the Middle East and Africa, particularly with Keyrus’ entry into the lucrative Saudi Arabian market. This move enables Keyrus to pursue its investment in a newly formed cybersecurity business, offering enhanced data security solutions to both existing and new clients.
Eric Cohen, Founder and CEO of Keyrus, expressed his enthusiasm: “This investment in Axon Technologies marks a significant step in our cybersecurity strategy. We’re embarking on an exciting journey to amplify our cybersecurity capabilities and establish a world-class global player in this domain. Axon Technologies’ innovative approach to consulting and managed services aligns perfectly with our vision and culture. We eagerly anticipate integrating Axon into our ecosystem to bolster our cybersecurity solutions and address the digital security challenges of our clients.”
Hadi Hosn, CEO of Axon Technologies, also shared his thoughts: “This partnership marks a new era for Axon Technologies, propelling us further in our mission to protect organizations from cyber threats. We admire the Keyrus vision and believe that our combined strengths will lead to disruptive data and cybersecurity solutions, addressing critical challenges in digital identity, application security, API, and data security across various environments and industries.”
Hadi Darwiche, Chairman of DIV Capital & Co-founder of Axon Technologies: “It’s gratifying to see Axon Technologies grow from a concept into a key player in the cybersecurity field. With Keyrus joining forces with us, we anticipate a period of sustained growth, leveraging our combined experience and established reputations. We are confident that together, Axon Technologies will continue to extend its market presence and deliver top-tier solutions.”
Comprehensive Cybersecurity Portfolio and Global Reach
In a relatively short period, Axon Technologies, founded in 2020, has emerged as a beacon of excellence and innovation in the cybersecurity field, demonstrating remarkable growth and agility in its operations. With a revenue of $3.2 million USD in 2023 and a projected substantial increase of the activities, it represents a testament to its robust business model, exceptional service delivery, and the trust clients place in Axon Technologies. The team made of 30 dedicated professionals is its most valuable asset. Axon Technologies commits to growing its team, fostering a culture of innovation, collaboration, and continuous learning.
Axon Technologies, renowned for its expertise in cybersecurity, will now be able to leverage Keyrus global presence and capabilities. With headquarters in Dubai and a significant footprint in the Middle East, Europe and Africa, Axon Technologies is well-positioned to monitor threats and support client cybersecurity programs across these regions effectively. With the backing of Keyrus’s global network, Axon Technologies is poised for unprecedented growth and are dedicated to setting new standards in the cybersecurity landscape.
The partnership is also expected to enhance the offerings of both companies. Axon Technologies’ expertise in Data Security, Cloud Security, DevSecOps and Managed Security Services aligns seamlessly with the Keyrus strategic objectives in digital, data, AI and cloud transformation initiatives.
About Axon Technologies
Axon Technologies offers comprehensive cybersecurity services including consulting, managed security services, engineering, and testing. The company is a leader in addressing critical infrastructure customers’ cybersecurity needs, from strategic consulting to hands-on management and technical security engineering support and managed security services, ensuring a robust and comprehensive approach to cybersecurity. The company’s service portfolio includes:
Technical Security Consulting & Advisory: Guidance and expertise for technical cybersecurity programs.Advanced Security Testing: Rigorous cybersecurity testing across the environment to identify and address vulnerabilities.Security Engineering & Architecture: Designing and implementing robust security architectures across on-premises and cloud environments.Managed Security Services: Ongoing management and support of cybersecurity operations. About Keyrus
Keyrus, an international player in the consulting and technology sectors and a specialist in data and digital technology, is dedicated to helping enterprises take advantage of the data and digital paradigm to enhance their performance, facilitate and accelerate their transformation, and generate new drivers of growth and competitiveness.
Placing innovation at the heart of its strategy, Keyrus develops a value proposition that is unique in the market and centred around five major service groups, each comprised of multiple solutions:
Automation and Artificial IntelligenceHuman-Centric Digital ExperienceData and Analytics enablementCloud and SecurityBusiness transformation and InnovationBuilding on the combined expertise of more than 3,500 employees active across 27 countries and 4 continents, Keyrus is one of the leading international experts in data, consulting and technology.
Keyrus is listed on Euronext Growth Paris. (ALKEY – ISIN Code: FR0004029411 – Reuters: KEYR.PA – Bloomberg: ALKEY: FP).
About DIV Capital
DIV Capital, originally starting as a family office, now operating as a strategic investment holding firm, specializing in bespoke advisory services. The firm focuses on fortifying family capital through comprehensive offerings that encompass support for early-stage enterprises, strategic asset allocation, and robust governance infrastructure development. The firm operates out of Geneva and Dubai and provides three core services:
Family Asset Support: Tailored support to construct an asset allocation that meets wealth goals.Family Financial Sponsorship: Reinforcement for family-operated businesses, aimed at fostering enduring value creation.Governance and Reporting: Consultation on governance frameworks and the enhancement of reporting standards for comprehensive asset oversight.Forward Looking Statements
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Axon Technologies, Keyrus or DIV Capital do not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will the companies and the affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.
Contact: [email protected]
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NDC Group and Valantic form a strategic partnership in EPM solutions

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PRAGUE, Feb. 27, 2024 /PRNewswire/ — NDC Group, a leading company in enterprise performance management (EPM) consultancy and data analytics is pleased to announce a strategic partnership with valantic, renowned digital solutions, consulting, and tech innovation company. Through this partnership, the companies aim to offer a joint portfolio of solutions and services in SAP planning and analytics.

Central to this collaboration is the delivery of NDC Financial Consolidation, which offers an automated and streamlined approach to legal and managerial consolidation. While the solution draws inspiration from the concept and functions of previously popular SAP consolidation solutions, it utilizes the modern technologies to enhance automation, performance, user experience, and seamless data integration.
The partnership also gives the chance to offer additional products, including SAC workforce planning content, SAP BusinessObjects migration accelerators, and pre-built content for SAC financial planning. Overall, the combined expertise and product offering enhance the ability of both companies to support customers in driving data-driven transformations within their organizations.
Stefan Blinkmann, Head of SAP Analytics at valantic, emphasizes: “We are very pleased about our new partnership, and we are convinced that our customers will benefit greatly from it. Above all, the NDC Group’s products create added value in the area of consolidation based on SAP Analytics Cloud, and they expand valantic’s range of services. An integrated solution for reporting, planning, and consolidation in SAP Analytics Cloud provides multiple benefits for our customers and enables them to streamline their system landscape.”
Karel Jirik, Head of Products at NDC Group, is also convinced of the benefits of this collaboration: “Our partnership with valantic is an excellent opportunity to leverage the synergies between our teams to streamline and transform our customers’ data landscape. The jointly offered EPM solutions enable precise and swift decision-making and enhance operational efficiency, crucial elements in today’s competitive landscape. I’m particularly pleased we found a lot of commonalities with valantic, and I am convinced together we can deliver better solutions in a shorter time.”
Vladislav Stefanak, CEO of NDC Group, reflects on the partnership’s potential: “This partnership embodies my vision of equipping our clients with advanced functionalities reminiscent of those found in SAP BPC and SAP Financial Consolidation, yet significantly enhanced by leveraging top-tier SAP technologies. Our collaboration with valantic commenced with remarkable synergy from the outset, underpinned by their extensive expertise and knowledge base.”
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