UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
(Exact name of registrant as specified in its charter)
|
(State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
(Address of principal executive offices and zip code)
(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 | ||
| The |
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 December 22, 2022, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing its financial results for the fiscal quarter and fiscal year ended September 30, 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated December 22, 2022 | |
| 104 | Cover Page Interactive Data File (embedded with Inline XBRL document). |
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.
| NEUROONE MEDICAL TECHNOLOGIES CORPORATION | ||
| Dated: December 22, 2022 | ||
| By: | /s/ David Rosa | |
| David Rosa | ||
| Chief Executive Officer | ||
Exhibit 99.1
NeuroOne® Reports Fiscal Fourth Quarter and Full Fiscal Year 2022 Financial Results
EDEN PRAIRIE, Minn., December 22, 2022 (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, announces financial results for the fiscal fourth quarter and full fiscal year ended September 30, 2022.
Dave Rosa, CEO of NeuroOne, commented, “The Company made great progress in fiscal 2022 in a wide variety of areas including commercialization, development and capital raises, which will allow us to continue to execute our plan, with the intent to introduce meaningful advances in electrode technology for a variety of neurological applications.
“Our independent registered public accounting firm has completed its audit procedures and we have filed our Annual Report on Form 10-K for the fiscal year ended September 30, 2022. Following are our financial results.”
Fourth Quarter and Full Year Fiscal 2022 Financial Results
Product revenue was $69,000 in the fourth quarter of fiscal 2022 and $171,000 for the full fiscal year, compared to product revenue of $48,000 in the fourth quarter and $178,000 for the full year of fiscal 2021. Collaboration revenue was $1,942,000 in the fourth quarter of fiscal 2022 and $1,949,000 for the full fiscal year, compared to collaboration revenue of $5,000 in the fourth quarter and $65,000 for the full year of fiscal 2021. 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 fourth quarter of fiscal 2022 were $3.3 million, compared with $2.6 million in the same period of the prior year. R&D expense in the fourth quarter of fiscal 2022 was $1.4 million compared with $1.0 million in the same period of fiscal 2021. SG&A expense in the fourth quarter of fiscal 2022 was $1.9 million compared with $1.6 million in the prior year period.
Total operating expenses for the full fiscal year 2022 were $11.9 million, compared with $10.2 million in the prior fiscal year. R&D expense for the full fiscal year 2022 was $4.9 million compared with $3.9 million in fiscal 2021. SG&A expense for the full fiscal year 2022 was $7.0 million compared with $6.2 million in the prior fiscal year.
Net loss was $1.4 million for the fourth quarter of fiscal 2022, compared to a net loss of $2.6 million in the prior year period. Net loss was $10.0 million for the full year fiscal 2022, compared to a net loss of $9.9 million in fiscal 2021.
As of September 30, 2022, the Company had cash, cash equivalents, and short-term investments of $11.1 million, compared to $6.9 million as of September 30, 2021. The Company had working capital of $9.1 million as of September 30, 2022, compared to working capital of $6.1 million as of September 30, 2021.
The Company had no debt outstanding at September 30, 2022.
About NeuroOne Medical Technologies Corporation
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 https://www.n1mtc.com .
Forward Looking Statements
This press release contains 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 “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “upcoming,” “target,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” 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 timing and extent of product launch and commercialization of our technology, clinical and pre-clinical testing, 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; risks that our sEEG electrodes may not be ready for commercialization in a timely manner or at all, whether due to supply chain disruptions 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 the COVID-19 pandemic will continue to adversely impact our business; 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@n1mtc.com
2
NeuroOne Medical Technologies Corporation
Balance Sheets (unaudited)
| As of September 30, | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,160,329 | $ | 6,901,346 | ||||
| Short-term investments | 2,981,010 | — | ||||||
| Accounts receivable | 33,237 | 48,336 | ||||||
| Inventory | 704,538 | 98,287 | ||||||
| Prepaid and other assets | 296,649 | 244,043 | ||||||
| Total current assets | 12,175,763 | 7,292,012 | ||||||
| Intangible assets, net | 111,892 | 134,207 | ||||||
| Right-of-use asset | 181,355 | 288,948 | ||||||
| Property and equipment, net | 353,599 | 223,329 | ||||||
| Total assets | $ | 12,822,609 | $ | 7,938,496 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 927,662 | $ | 528,829 | ||||
| Accrued expenses | 715,839 | 644,249 | ||||||
| Deferred revenue | 1,455,188 | 8,622 | ||||||
| Total current liabilities | 3,098,689 | 1,181,700 | ||||||
| Operating lease liability, long term | 119,556 | 202,895 | ||||||
| Total liabilities | 3,218,245 | 1,384,595 | ||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized as of September 30, 2022 and 2021; no shares issued or outstanding as of September 30, 2022 and 2021. | — | — | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized as of September 30, 2022 and 2021; 16,216,540 and 12,010,019 shares issued and outstanding as of September 30, 2022 and 2021, respectively. | 16,217 | 12,010 | ||||||
| Additional paid–in capital | 60,414,959 | 47,369,090 | ||||||
| Accumulated deficit | (50,826,812 | ) | (40,827,199 | ) | ||||
| Total stockholders’ equity | 9,604,364 | 6,553,901 | ||||||
| Total liabilities and stockholders’ equity | $ | 12,822,609 | $ | 7,938,496 | ||||
See accompanying notes to the financial statements
3
NeuroOne Medical Technologies Corporation
Statements of Operations (unaudited)
| Years ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| Product revenue | $ | 171,169 | $ | 178,146 | ||||
| Cost of product revenue | 241,963 | 275,895 | ||||||
| Product gross loss | (70,794 | ) | (97,749 | ) | ||||
| Collaborations revenue | 1,948,872 | 64,812 | ||||||
| Operating expenses: | ||||||||
| Selling, general and administrative | 6,979,416 | 6,260,266 | ||||||
| Research and development | 4,929,427 | 3,925,008 | ||||||
| Total operating expenses | 11,908,843 | 10,185,274 | ||||||
| Loss from operations | (10,030,765 | ) | (10,218,211 | ) | ||||
| Interest expense | — | (3,053 | ) | |||||
| Net valuation change of instruments measured at fair value | — | 1,974 | ||||||
| Other income | 31,152 | 271,122 | ||||||
| Net loss | $ | (9,999,613 | ) | $ | (9,948,168 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.63 | ) | $ | (0.93 | ) | ||
| Number of shares used in per share calculations: | ||||||||
| Basic and diluted | 15,998,567 | 10,696,799 | ||||||
See accompanying notes to the financial statements
4
Cover |
Dec. 22, 2022 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Dec. 22, 2022 |
| Entity File Number | 001-40439 |
| Entity Registrant Name | NeuroOne Medical Technologies Corporation |
| Entity Central Index Key | 0001500198 |
| Entity Tax Identification Number | 27-0863354 |
| Entity Incorporation, State or Country Code | DE |
| Entity Address, Address Line One | 7599 Anagram Dr. |
| Entity Address, City or Town | Eden Prairie |
| Entity Address, State or Province | MN |
| Entity Address, Postal Zip Code | 55344 |
| City Area Code | 952 |
| Local Phone Number | 426-1383 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock, par value $0.001 per share |
| Trading Symbol | NMTC |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |