8-K
NEUROONE MEDICAL TECHNOLOGIES Corp (NMTC)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): February 14, 2023
NeuroOneMedical Technologies Corporation
(Exact name of registrant as specified in its charter)
| Delaware | 001-40439 | 27-0863354 |
|---|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (Commission<br> File Number) | (IRS Employer<br><br> <br>Identification No.) |
7599Anagram Dr., Eden Prairie, MN 55344
(Address of principal executive offices and zip code)
952-426-1383
(Registrant’s telephone number including area code)
(Registrant’s former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.001 per share | NMTC | The<br> Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item2.02 Results of Operations and Financial Condition.
On February 14, 2023, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended December 31, 2022. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
Item7.01 Regulation FD Disclosure.
On February 14, 2023, the Company posted an updated corporate fact sheet to its website at www.nmtc1.com/investors, which the Company may use from time to time in communications or conferences. A copy of the corporate fact sheet is furnished herewith as Exhibit 99.2 to this Current Report and is incorporated herein by reference.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01, and Exhibit 99.2 hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing. The Company’s submission of this Current Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
This Current Report and Exhibit 99.2 hereto contain forward-looking statements within the meaning of the federal securities laws. These forward looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit 99.2 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.
Item9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated February 14, 2023 |
| 99.2 | Corporate Fact Sheet, dated February 14, 2023 |
| 104 | Cover Page Interactive Data File (embedded with Inline XBRL document). |
| 1 |
| --- |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NOONE<br> MEDICAL TECHNOLOGIES CORPORATION | |
|---|---|
| Dated:<br> February 14, 2023 | |
| By: | |
All values are in Euros.
2
Exhibit99.1
NeuroOne^®^Reports First Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update
EDEN PRAIRIE, Minn., February 14, 2023 (PR 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 first quarter 2023 ended December 31, 2022.
Fiscal First Quarter 2023 and Recent BusinessUpdates
| · | Received FDA 510(k) clearance to market the Evo® sEEG Electrode technology<br>for temporary (less than 30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation<br>of electrical signals at the subsurface level of the brain, enabling NeuroOne to fully address the approximately $100M diagnostic electrode<br>market. |
|---|---|
| · | A feasibility animal study of the Company’s OneRF® therapeutic<br>radiofrequency ablation electrode system was completed under the guidance of Dr. Jamie Van Gompel at the Mayo Clinic in Rochester,<br>MN. OneRF is an sEEG probe-guided RF based system to monitor and adjust settings based on temperature throughout an ablation, a feature<br>designed to improve the safety of the procedure. |
| --- | --- |
| · | The first commercial order of Evo^®^ sEEG electrodes for temporary<br>use (less than 30 days) was shipped to the Company’s distribution and development partner Zimmer Biomet. NeuroOne continues to build<br>up inventory to meet product forecasts and fulfill additional orders in-house. |
| --- | --- |
| · | The Company developed and successfully bench tested an early prototype of<br>a first-of-a-kind device that can deliver drugs (or other diagnostic or therapeutic agents) to the brain while also having the capability<br>to stimulate and record before and after application. |
| --- | --- |
| · | Held discussions with strategic organizations regarding the Company’s<br>technology in an effort to potentially expand the product footprint in neurology. |
| --- | --- |
| · | Exhibited the Evo electrode product family with Zimmer Biomet at the Congress<br>of Neurological Surgeons annual meeting and the American Epilepsy Society and Congress of Neurological Surgeons annual meetings. |
| --- | --- |
| · | The Company’s scientific posters were presented at the following meetings: |
| --- | --- |
| · | Congress of Neurosurgical Surgeons: Title: A Novel Polyimide Stereo-electroencephalographic<br>(sEEG) Electrode: Safety and Performance Testing |
| --- | --- |
| · | Society of Neuroscience Meeting: Title: A Novel Polyimide-Based Electroencephalographic<br>Depth Electrode Array: Safety and Performance Testing |
| --- | --- |
| · | American Epilepsy Society Annual Meeting: Title: Novel Polyimide Stereoelectroencephalographic<br>Depth Electrodes: Safety and Performance Testing |
| --- | --- |
| · | CEO Dave Rosa featured on Fox Business Network’s ‘Mornings with<br>Maria.’ |
| --- | --- |
| · | Rang Nasdaq Stock Market closing bell to commemorate the FDA clearance milestone<br>for Evo sEEG Electrode technology. |
| --- | --- |
Dave Rosa, CEO of NeuroOne, commented, “We were thrilled to receive FDA clearance of our Evo sEEG electrode, which was the culmination of years of hard work and determination. This represents the beginning of our commercialization strategy with Zimmer Biomet. Just as critical, we are well positioned to submit our OneRF Ablation System to the FDA for 510(k) clearance, marking a key milestone for the Company as we enter the therapeutic space. We continue to explore additional exciting markets as we seek to improve upon existing technology with the goal of making current procedures safer and more cost effective, with potential improved efficacy for patients suffering from epilepsy, Parkinson’s disease, and chronic pain. We also continue to explore potential strategic partnerships to expand our presence beyond our current areas of focus.”
Upcoming Targeted Milestones
| · | Commercial launch of Evo sEEG electrodes with Zimmer Biomet in the first<br>quarter of calendar year 2023. |
|---|---|
| · | Along with Zimmer Biomet, present the newly launched Evo sEEG system at the<br>American Association of Neurological Surgeons (AANS) annual meeting at the end of April 2023. |
| --- | --- |
| · | Submit a 510(k) application to the FDA for OneRF in the second quarter of<br>calendar year 2023. |
| --- | --- |
| · | Complete design verification testing for OneRF confirming that the full feature<br>system meets its design specifications and is fully functional. |
| --- | --- |
| · | Complete next in vivo animal testing of the OneRF system with multiple surgeons<br>with the objective of gathering additional in vivo data on the system’s performance. |
| --- | --- |
| · | Pre-clinical implantation for spinal cord stimulation (SCS) electrodes intended<br>for permanent implant to treat chronic pain. |
| --- | --- |
Fiscal First Quarter 2023 Financial Results
Product revenue was $115,000 in the fiscal first quarter 2023, compared to product revenue of $34,000 in the fiscal first quarter 2022. Collaboration revenue was $1.46 million in the fiscal first quarter 2023, compared to collaboration revenue of $6,000 in the fiscal first quarter 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 first quarter 2023 were $3.2 million, compared with $2.8 million in the same period of the prior fiscal year. R&D expense in the fiscal first quarter 2023 was $1.6 million compared with $1.1 million in the same period of fiscal 2022. SG&A expense in the fiscal first quarter 2023 was $1.7 million compared with $1.7 million in the prior year period.
Net loss was $1.7 million for the fiscal first quarter 2023, compared to a net loss of $2.8 million in the prior year period.
As of December 31, 2022, the Company had cash, cash equivalents, and short-term investments of $7.6 million, compared to $11.1 million as of September 30, 2022. The Company had working capital of $7.6 million as of December 31, 2022, compared to working capital of $9.1 million as of September 30, 2022.
The Company had no debt outstanding as of December 31, 2022.
2
Conference Call and Webcast Information
Tuesday, February 14, 2023 – 4:30 PM Eastern Time
Participant Dial-In:
877-405-1216 / 201-689-8336
Live Webcast: ****
Join here
Phone Replay:
877-660-6853 / 201-612-7415, Access ID: 13736384; available through February 28, 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, cost reduction of our new cable assembly, shelf life for Evo cortical electrodes, expected negotiations with Zimmer Biomet, clinical and pre-clinical testing, what the future may hold for electrical stimulation and NeuroOne’s potential role, 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
ir@nmtc1.com
3
NeuroOne Medical Technologies Corporation
Balance Sheets
(unaudited)
| September 30, <br> 2022 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 4,667,432 | $ | 8,160,329 | ||
| Short-term investments | 2,975,194 | 2,981,010 | |||
| Accounts receivable | 95,319 | 33,237 | |||
| Inventory | 903,554 | 704,538 | |||
| Prepaid and other assets | 325,488 | 296,649 | |||
| Total current assets | 8,966,987 | 12,175,763 | |||
| Intangible assets, net | 106,313 | 111,892 | |||
| Right-of-use asset | 252,119 | 181,355 | |||
| Property and equipment, net | 334,801 | 353,599 | |||
| Total assets | 9,660,220 | $ | 12,822,609 | ||
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 861,638 | $ | 927,662 | ||
| Accrued expenses | 473,085 | 715,839 | |||
| Deferred revenue | — | 1,455,188 | |||
| Total current liabilities | 1,334,723 | 3,098,689 | |||
| Operating lease liability, long term | 153,721 | 119,556 | |||
| Total liabilities | 1,488,444 | 3,218,245 | |||
| Commitments and contingencies (Note 4) | |||||
| Stockholders’ equity: | |||||
| Preferred stock, 0.001 par value; 10,000,000 shares authorized as of December 31, 2022 and September 30, 2022; no shares issued or outstanding as of December 31, 2022 and September 30, 2022. | — | — | |||
| Common stock, 0.001 par value; 100,000,000 shares authorized as of December 31, 2022 and September 30, 2022; 16,238,464 and 16,216,540 shares issued and outstanding as of December 31, 2022 and September 30, 2022, respectively. | 16,239 | 16,217 | |||
| Additional paid–in capital | 60,715,118 | 60,414,959 | |||
| Accumulated deficit | (52,559,581 | ) | (50,826,812 | ) | |
| Total stockholders’ equity | 8,171,776 | 9,604,364 | |||
| Total liabilities and stockholders’ equity | 9,660,220 | $ | 12,822,609 |
All values are in US Dollars.
See accompanying notes to condensed financial statements
4
NeuroOne Medical Technologies Corporation
Statements of Operations
(unaudited)
| For the three months ended<br> December 31, | ||||||
|---|---|---|---|---|---|---|
| 2022 | 2021 | |||||
| Product revenue | $ | 114,579 | $ | 33,748 | ||
| Cost of product revenue | 126,886 | 46,844 | ||||
| Product gross loss | (12,307 | ) | (13,096 | ) | ||
| Collaborations revenue | 1,455,188 | 6,374 | ||||
| Operating expenses: | ||||||
| Selling, general and administrative | 1,663,737 | 1,742,141 | ||||
| Research and development | 1,563,496 | 1,060,462 | ||||
| Total operating expenses | 3,227,233 | 2,802,603 | ||||
| Loss from operations | (1,784,352 | ) | (2,809,325 | ) | ||
| Other income | 51,583 | 1,850 | ||||
| Loss before income taxes | (1,732,769 | ) | (2,807,475 | ) | ||
| Provision for income taxes | — | — | ||||
| Net loss | $ | (1,732,769 | ) | $ | (2,807,475 | ) |
| Net loss per share: | ||||||
| Basic and diluted | $ | (0.11 | ) | $ | (0.18 | ) |
| Number of shares used in per share calculations: | ||||||
| Basic and diluted | 16,230,997 | 15,408,480 |
See accompanying notes to condensed financial statements
5
Exhibit 99.2
