NMTC 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): August 13, 2021
NeuroOne Medical Technologies Corporation
(Exact name of registrant as specified in its charter)
| Delaware | 000-54716 | 27-0863354 | ||
(State
or other jurisdiction of incorporation) |
(Commission File Number) | (IRS
Employer |
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 $0.001 per share | NMTC | The 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. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 13, 2021, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2021. 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 13, 2021 |
| 1 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NEUROONE MEDICAL TECHNOLOGIES CORPORATION | ||
| Dated: August 13, 2021 | ||
| By: | /s/ David Rosa | |
| David Rosa | ||
| Chief Executive Officer | ||
2
Exhibit 99.1
NeuroOne Reports Third Quarter Fiscal 2021 Financial Results and Corporate Update
EDEN PRAIRIE, Minn. -- 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 today financial results for the quarter ended June 30, 2021.
Third Quarter and Fiscal 2021 Recent Business Updates
| ● | Uplisted to the Nasdaq Capital Market under existing ticker symbol "NMTC" |
| ● | Launched the first product, the Evo Cortical Electrode, with Zimmer Biomet |
| ● | Submitted a 510(k) to FDA for Company’s Evo sEEG Electrode |
| ● | Initiated testing for electrodes intended to provide therapeutic stimulation for back pain which represents over a $3 billion market in the United States |
| ● | Completed the initial manufacturing run for miniaturized electrodes that may be useful in more complex conditions requiring artificial intelligence |
| ● | Formed an advisory board of leading neurosurgeons to assist in accelerating its ablation electrode program |
| ○ | Multifunction electrode intended to both record brain activity and ablate the problematic brain tissue |
| ○ | Expected to reduce hospitalizations, eliminate the need for a separate second surgery and reduce overall time and cost |
| ○ | Company intends to market the hardware and software as well |
| ● | Completed first performance milestone in Zimmer Biomet agreement |
| ● | Announced first human commercial use of its Evo Cortical diagnostic electrode at Mayo Clinic in Rochester, Minnesota |
| ● | Appointed 30-year finance executive, Ronald McClurg, as Chief Financial Officer |
| ● | Appointed 20-year Medtronic veteran, Hijaz Haris, as Vice President of Marketing |
| ● | Closed a $12.5 million private placement with certain prominent institutional investors |
1
Dave Rosa, CEO of NeuroOne commented, “During our fiscal third quarter and year to date, we made significant progress across our product portfolio. We began the period with the first human commercial use of our first FDA approved diagnostic product at Mayo Clinic. We submitted a 510(k) for our second diagnostic product line and remain on target to commercialize by calendar year end. We continue to make great progress on our ablation electrode, which will be our first therapeutic device, and are targeting a launch in the next eighteen months. Additionally, we expect data on our chronic use electrode technology later this year. Coupled with adding key personnel, prominent institutional investors in a $12.5 million capital raise, and uplisting to the Nasdaq Capital Market, we’ve had a strong fiscal 2021 to date and are focused on executing upcoming milestones to maximize shareholder value.”
Upcoming Targeted Milestones
| ● | Commercialize Evo sEEG Depth Diagnostic Electrode in Calendar 2021 |
| ○ | Uses include epilepsy surgery and awake brain mapping |
| ○ | Triggers a milestone payment from Zimmer for licensing fee |
| ○ | ~$100 million addressable market |
| ● | Complete the design of the Ablation Therapeutic Electrode and longer pacing item pulse generator in Calendar 2021 |
| ○ | Multifunction electrode intended to both record brain activity and ablate the problematic brain tissue |
| ○ | Expected to reduce hospitalizations, eliminate the need for a separate second surgery and reduce overall time and cost |
| ○ | Company intends to market the hardware and software as well. |
| ● | Complete animal studies for the Ablation Therapeutic Electrode in Calendar 2021 |
| ● | Generate accelerated aging testing data for Chronic Use Electrode in Calendar 2021 |
| ○ | Uses include deep brain stimulation, spinal cord stimulation, and future artificial intelligence applications |
| ○ | ~$6-billion addressable market |
| ● | Commercialize the Ablation Therapeutic Electrode in the next eighteen months |
Third Quarter 2021 Financial Results
Product revenue was $40,000 in the third quarter of fiscal 2021 and collaboration revenue was $17,000, compared to no revenue in the prior year period.
2
Total operating expenses in the third quarter of fiscal 2021 were $3.0 million, compared with $1.6 million in the same period of the prior year. R&D expense in the third quarter was $2.1 million compared with $1.1 million in the same period of fiscal 2020. SG&A expense in the third quarter of fiscal 2021 was $0.9 million compared with $0.45 million in the prior year period.
Net loss was $3.0 million for the third quarter fiscal 2021, compared to a net loss of $7.1 million in the prior year period.
As of June 30, 2021, the Company had cash of $9.0 million, compared to $4.0 million at September 30, 2020, the end of the Company’s most recent fiscal year. The Company had no debt outstanding at June 30, 2021.
Conference Call Information
NeuroOne will host a conference call to discuss financial results for its third quarter ended June 30, 2021, on August 13, 2021, at 9:00 AM ET.
Dial-in: (346) 248-7799
Meeting ID: 95665935395
Passcode: 902419
Webcast: https://audience.mysequire.com/webinar-view?webinar_id=ebb66f45-34a2-4d94-b4b9-f830d498fc2f
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.
3
The Company previously announced it had successfully met the first performance milestone in the distribution and development agreement signed with Zimmer Biomet on July 20, 2020 . In addition to acquiring exclusive global distribution rights to NeuroOne's Evo™ (Evo) patented electrode technology, the partnership also offered the potential for NeuroOne to earn back-end milestone payments if certain events were met within a specified time frame.
NeuroOne received FDA clearance for its Evo cortical technology in November 2019.
In partnership with Mayo Clinic, Wisconsin Alumni Research Foundation (WARF) and other prominent academic medical centers, the Company began developing its cortical electrode technology in 2015. The Company initially focused its efforts on the epilepsy and intraoperative tumor monitoring markets. NeuroOne intends to continue to develop the technology for use in therapeutic applications for Parkinson's disease, epilepsy and pain management due to failed back surgery procedures.
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," "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 Company's ablation electrode technology program, the receipt of regulatory clearance, the timing and extent of product launch and commercialization of the technology, 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; risks that our sEEG electrodes may not be ready for commercialization in a timely manner or at all; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials, our ability to raise additional funds, uncertainties inherent in the development process of our technology, changes in regulatory requirements or decisions of regulatory authorities, the size and growth potential of the markets for our technology, clinical trial patient enrollment, the results of clinical trials, our ability 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:
James
Carbonara
Hayden IR
(646)-755-7412
[email protected]
4
NeuroOne Medical Technologies Corporation
Condensed Balance Sheets
| As of June 30, 2021 | As of September 30, 2020 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 8,990,741 | $ | 4,036,397 | ||||
| Accounts receivable | 40,096 | — | ||||||
| Inventory | 52,182 | — | ||||||
| Prepaid and other assets | 188,409 | 118,611 | ||||||
| Total current assets | 9,271,428 | 4,155,008 | ||||||
| Intangible assets, net | 139,786 | 156,523 | ||||||
| Right-of-use asset | 241,156 | 282,211 | ||||||
| Property and equipment, net | 156,353 | 166,031 | ||||||
| Total assets | $ | 9,808,723 | $ | 4,759,773 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 296,410 | $ | 762,538 | ||||
| Accrued expenses | 436,846 | 512,762 | ||||||
| Convertible promissory notes (Note 8) | — | 1,007,206 | ||||||
| Deferred revenue | 13,596 | 73,434 | ||||||
| Total current liabilities | 746,852 | 2,355,940 | ||||||
| Operating lease liability | 206,966 | 254,328 | ||||||
| Other liabilities | — | 83,333 | ||||||
| Total liabilities | 953,818 | 2,693,601 | ||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized as of June 30, 2021 and September 30, 2020; no shares issued or outstanding as of June 30, 2021 and September 30, 2020. | — | — | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized as of June 30, 2021 and September 30, 2020; 11,981,380 and 7,393,637 shares issued and outstanding as of June 30, 2021 and September 30, 2020, respectively. | 35,801 | 22,181 | ||||||
| Additional paid–in capital | 47,003,140 | 32,923,022 | ||||||
| Accumulated deficit | (38,184,036 | ) | (30,879,031 | ) | ||||
| Total stockholders’ equity | 8,854,905 | 2,066,172 | ||||||
| Total liabilities and stockholders’ equity | $ | 9,808,723 | $ | 4,759,773 | ||||
5
NeuroOne Medical Technologies Corporation
Condensed Statements of Operations
(unaudited)
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Product revenue | $ | 40,096 | $ | — | $ | 129,810 | $ | — | ||||||||
| Cost of product revenue | 61,935 | — | 210,429 | — | ||||||||||||
| Product gross loss | (21,839 | ) | — | (80,619 | ) | — | ||||||||||
| Collaborations revenue | 17,451 | — | 59,838 | — | ||||||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative | 2,129,474 | 1,146,339 | 4,636,586 | 3,493,761 | ||||||||||||
| Research and development | 901,134 | 447,154 | 2,916,721 | 1,291,075 | ||||||||||||
| Total operating expenses | 3,030,608 | 1,593,493 | 7,553,307 | 4,784,836 | ||||||||||||
| Loss from operations | (3,034,996 | ) | (1,593,493 | ) | (7,574,088 | ) | (4,784,836 | ) | ||||||||
| Interest expense | — | (4,749,263 | ) | (3,053 | ) | (7,446,770 | ) | |||||||||
| Net valuation change of instruments measured at fair value | — | 1,269,543 | 1,974 | 1,175,685 | ||||||||||||
| Loss on note extinguishment | — | (2,017,847 | ) | — | (2,017,847 | ) | ||||||||||
| Other income | 83,387 | — | 270,162 | — | ||||||||||||
| Loss before income taxes | (2,951,609 | ) | (7,091,060 | ) | (7,305,005 | ) | (13,073,768 | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (2,951,609 | ) | $ | (7,091,060 | ) | $ | (7,305,005 | ) | $ | (13,073,768 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.25 | ) | $ | (1.33 | ) | $ | (0.71 | ) | $ | (2.70 | ) | ||||
| Number of shares used in per share calculations: | ||||||||||||||||
| Basic and diluted | 11,959,101 | 5,346,439 | 10,269,216 | 4,843,587 | ||||||||||||
6