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 SecuritiesExchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 14, 2023
NeuroOne Medical Technologies Corporation
(Exact name of registrant as specified in its charter)
| Delaware | 001-40439 | 27-0863354 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
7599 Anagram 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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement 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 Stock, par value<br> $0.001 per share | NMTC | The Nasdaq Stock Market<br> 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. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 14, 2023, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended June 30, 2023. 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated August 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 MEDICAL TECHNOLOGIES CORPORATION | |
|---|---|
| Dated: August 14, 2023 | By: |
All values are in Euros.
2
Exhibit 99**.1**
NeuroOne^®^Reports Third Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update
EDEN PRAIRIE, Minn., August 14, 2023 (GlobeNewswire) -- 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 third quarter 2023 ended June 30, 2023.
FiscalThird Quarter 2023 and Recent Business Updates
Financial Highlights
| ● | Product<br> revenue of $630,000 in Q3 2023, compared to $32,000 in Q3 2022 |
|---|---|
| ● | Collaboration<br> revenue of $1.46 million in first nine months of FY 2023, compared to $6,000 in first nine<br> months of FY 2022 |
| --- | --- |
| ● | Operating<br> cash burn reduction expected with the completion of development of the OneRF™ Ablation<br> System beginning in Fiscal Q4 2023 |
| --- | --- |
Evo^®^sEEG:
| ● | Completed<br> limited launch at target centers by end of July; full launch with Zimmer Biomet expected<br> by end of fiscal fourth quarter |
|---|---|
| ● | Positive<br> user feedback received on product evaluation forms |
| --- | --- |
| ● | Initiation<br> of new sites expected to ramp in fiscal fourth quarter |
| --- | --- |
| ● | Received<br> first order for calendar 2024 product supply from Zimmer Biomet |
| --- | --- |
OneRF™Ablation:
| ● | Submitted<br> 510(k) to FDA on June 8th |
|---|---|
| ● | Poster<br> presentation on OneRF Ablation System preclinical study at the Neurological Disorders Summit<br> (NDS 2023) in Italy |
| --- | --- |
| ● | Received<br> feedback from FDA regarding 510(k) submission for OneRF Ablation System |
| --- | --- |
Spinal Cord Stimulation Program:
| ● | Completed<br> 28 day animal implants of the Company’s thin film spinal cord stimulation paddle electrodes<br> without any adverse events or neurological complications |
|---|---|
| ● | Filed<br> a non-provisional patent for a novel conformable thin film paddle lead for spinal cord placement |
| --- | --- |
Drug Delivery Program:
| ● | Successfully<br> completed proof of concept testing of drug delivery into the brain in a small animal model<br> at the Mayo Clinic in Rochester, Minnesota |
|---|
Dave Rosa, CEO of NeuroOne, commented, “The Company continues to execute on a number of commercial, development and financing objectives. We are now beginning to expand the commercial launch of our Evo sEEG electrode with Zimmer Biomet after a successful limited launch. In addition, we received encouraging feedback from the FDA regarding the Company’s recent 510(k) FDA submission of the OneRF Ablation System and believe our previous timelines remain on track. We are excited by the potential of our drug delivery system currently in development after recent testing at the Mayo Clinic in Rochester Minnesota. We also recently raised gross proceeds of $6.0 million through a public offering which included new fundamental institutional investors without having to offer warrants and $2.5 million through the use of an ATM (at-the-market) facility. I am pleased with the Company’s continued execution on our strategic plan and I look forward to our future progress in the areas outlined.”
UpcomingTargeted Milestones
Evo sEEG:
| ● | Full<br> market launch of Evo sEEG system with Zimmer Biomet |
|---|---|
| ● | Expand<br> sales training of the sEEG product line to Zimmer personnel |
| --- | --- |
OneRF Ablation:
| ● | Poster<br> presentation planned for the Congress of Neurological Surgeons (CNS) Meeting in September |
|---|---|
| ● | Initiate<br> component orders for OneRF ablation system for future commercialization |
| --- | --- |
SCS Program:
| ● | Complete<br> testing of an implantable pulse generator (IPG) for fluid ingress |
|---|---|
| ● | Perform<br> percutaneous placement of a paddle electrode in a human cadaver model |
| --- | --- |
2
Drug Delivery Program:
| ● | Define<br> product requirements for drug delivery system for both clinical and research use in the biotech<br> and pharma industry |
|---|---|
| ● | Complete<br> large animal feasibility studies for drug delivery system into the brain. |
| --- | --- |
FiscalThird Quarter 2023 Financial Results
Product revenue was $630,000 in the fiscal third quarter 2023, compared to product revenue of $32,000 in the fiscal third quarter 2022. For the first nine months of fiscal 2023, product revenue was $1.2 million, compared to $102,000 for the same period in fiscal 2022. Collaboration revenue was $1.46 million in the first nine months of fiscal 2023, compared to collaboration revenue of $6,000 in the first nine 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 third quarter 2023 were $3.8 million, compared with $2.8 million in the same period of the prior fiscal year. Research and Development (R&D) expense in the fiscal third quarter 2023 was $1.9 million compared with $1.2 million in the same period of fiscal 2022. Selling, General and Administrative (SG&A) expense in the fiscal third quarter 2023 was $1.9 million compared with $1.5 million in the prior year period. For the first nine months of fiscal 2023, total operating expenses were $10.5 million, compared with $8.6 million in the same period of the prior fiscal year. R&D expense in the first nine months of fiscal 2023 was $5.2 million compared with $3.5 million in the same period of fiscal 2022. SG&A expense in the first nine months of fiscal 2023 was $5.3 million compared with $5.1 million in the prior year period.
Net loss was $3.5 million for the fiscal third quarter 2023, compared to a net loss of $2.8 million in the prior year period. Net loss for the first nine months of fiscal 2023 was $8.7 million compared with $8.6 million in the same period of fiscal 2022.
As of June 30, 2023, the Company had cash and cash equivalents of $3.1 million, compared to $8.1 million in cash and cash equivalents and $3.0 million in short term investments as of September 30, 2022. The Company had working capital of $3.1 million as of June 30, 2023, compared to working capital of $9.1 million as of September 30, 2022.
3
On July 27, 2023, the Company consummated an underwritten public offering of its common stock from which the Company received $5.2 million in net proceeds. In addition, the Company sold common stock under the ATM program from which the Company received net proceeds of $2.5 million.
The Company had no debt outstanding as of June 30, 2023.
ConferenceCall and Webcast Information
Monday, August 14, 2023 – 4:30 PM Eastern Time
Participant Dial-In:
800-267-6316/+1 203-518-9783
Conference ID (required for entry): NEURO
Live Webcast: ****
Join here.
Phone Replay:
877-660-6853 / 201-612-7415,
Available through August 28, 2023
Webcast Replay:
Available for 12 months
AboutNeuroOne
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.
4
ForwardLooking 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
ir@nmtc1.com
5
NeuroOneMedical Technologies Corporation
CondensedBalance Sheets
(unaudited)
| September 30, <br> 2022 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 3,083,458 | $ | 8,160,329 | ||
| Short-term investments | — | 2,981,010 | |||
| Accounts receivable | — | 33,237 | |||
| Inventory | 1,516,527 | 704,538 | |||
| Prepaids and other | 278,786 | 296,649 | |||
| Total current assets | 4,878,771 | 12,175,763 | |||
| Intangible assets, net | 95,156 | 111,892 | |||
| Right-of-use asset | 197,324 | 181,355 | |||
| Property and equipment, net | 586,873 | 353,599 | |||
| Total assets | 5,758,124 | $ | 12,822,609 | ||
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 958,811 | $ | 927,662 | ||
| Accrued expenses and other liabilities | 789,097 | 715,839 | |||
| Deferred revenue | — | 1,455,188 | |||
| Total current liabilities | 1,747,908 | 3,098,689 | |||
| Operating lease liability, long term | 88,918 | 119,556 | |||
| Total liabilities | 1,836,826 | 3,218,245 | |||
| Commitments and contingencies (Note 4) | |||||
| Stockholders’ equity: | |||||
| Preferred stock, 0.001 par value; 10,000,000 shares authorized as of June 30, 2023 and September 30, 2022; no shares issued or outstanding as of June 30, 2023 and September 30, 2022. | — | — | |||
| Common stock, 0.001 par value; 100,000,000 shares authorized as of June 30, 2023 and September 30, 2022; 17,862,162 and 16,216,540 shares issued and outstanding as of June 30, 2023 and September 30, 2022, respectively. | 17,862 | 16,217 | |||
| Additional paid–in capital | 63,454,618 | 60,414,959 | |||
| Accumulated deficit | (59,551,182 | ) | (50,826,812 | ) | |
| Total stockholders’ equity | 3,921,298 | 9,604,364 | |||
| Total liabilities and stockholders’ equity | 5,758,124 | $ | 12,822,609 |
All values are in US Dollars.
See accompanying notes to condensed financial statements
6
NeuroOneMedical Technologies Corporation
CondensedStatements of Operations
(unaudited)
| For the Three Months Ended | For the nine Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| June 30, | June 30, | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| Product revenue | $ | 629,906 | $ | 32,049 | $ | 1,210,661 | $ | 102,381 | ||||
| Cost of product revenue | 386,240 | 38,462 | 947,799 | 158,113 | ||||||||
| Product gross profit (loss) | 243,666 | (6,413 | ) | 262,862 | (55,732 | ) | ||||||
| Collaborations revenue | — | — | 1,455,188 | 6,374 | ||||||||
| Operating expenses: | ||||||||||||
| Selling, general and administrative | 1,862,389 | 1,529,670 | 5,347,234 | 5,090,018 | ||||||||
| Research and development | 1,891,512 | 1,225,351 | 5,161,322 | 3,491,193 | ||||||||
| Total operating expenses | 3,753,901 | 2,755,021 | 10,508,556 | 8,581,211 | ||||||||
| Loss from operations | (3,510,235 | ) | (2,761,434 | ) | (8,790,506 | ) | (8,630,569 | ) | ||||
| Other income, net | 41,462 | 1,707 | 66,136 | 5,300 | ||||||||
| Loss before income taxes | (3,468,773 | ) | (2,759,727 | ) | (8,724,370 | ) | (8,625,269 | ) | ||||
| Provision for income taxes | — | — | ||||||||||
| Net loss | $ | (3,468,773 | ) | $ | (2,759,727 | ) | $ | (8,724,370 | ) | $ | (8,625,269 | ) |
| Net loss per share: | ||||||||||||
| Basic and diluted | $ | (0.20 | ) | $ | (0.17 | ) | $ | (0.52 | ) | $ | (0.54 | ) |
| Number of shares used in per share calculations: | ||||||||||||
| Basic and diluted | 17,578,871 | 16,193,442 | 16,740,546 | 15,927,734 |
See accompanying notes to condensed financial statements
7