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): May 14, 2024
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 $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 May 14, 2024, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2024. 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 May 14, 2024 |
| 104 | Cover Page Interactive Data File (embedded with Inline XBRL document). |
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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: May 14, 2024 | |
| By: | |
All values are in Euros.
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Exhibit 99.1
NeuroOne^®^Reports Second Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update
EDEN PRAIRIE, Minn., May 14, 2024 (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 second quarter fiscal year 2024 ended March 31, 2024.
SecondQuarter Fiscal Year 2024 and Recent Business Updates
Financial Highlights:
| ● | Product<br> revenue of $1,377,000 in Q2 2024, compared to $466,000 in Q2 2023 |
|---|---|
| ● | Raised<br> an additional $2.0 million using the ATM Program in Q2 2024 |
| --- | --- |
Evo^®^sEEG:
| ● | Zimmer<br> Biomet continued to expand into new accounts |
|---|---|
| ● | Product<br> exhibited by Zimmer Biomet at the American Association of Neurological Surgeons (AANS) in<br> May |
| --- | --- |
OneRF™ Ablation System:
| ● | Completed<br> site training and initiated limited commercial launch of the OneRF™ Ablation System<br> in late March |
|---|---|
| ● | Successfully<br> implanted five patients |
| --- | --- |
| ● | Completed<br> initial manufacturing run for limited commercial launch |
| --- | --- |
| ● | Presented<br> ICD-10-PCS hospital inpatient code application to the Centers for Medicare and Medicaid Services<br> (CMS) in March for the OneRF™ ablation procedure to support accurate data collection<br> and processing of reimbursement claims by hospitals for the ablation procedure |
| --- | --- |
| ● | Exhibited<br> the OneRF™ Ablation System at the AANS meeting in May |
| --- | --- |
Drug Delivery Program:
| ● | Completed<br> feasibility bench top testing and animal study demonstrating the ability to deliver a therapeutic<br> agent and provide recording capabilities using the sEEG drug delivery system |
|---|---|
| ● | Continued<br> discussions with potential strategic partners for use in clinical studies and research |
| --- | --- |
Spinal Cord Stimulation Program:
| ● | Completed<br> animal study to evaluate stimulation and battery performance using the Company’s spinal<br> cord stimulation electrode technology |
|---|---|
| ● | Led<br> by our Spinal Cord Stimulation Advisory Board, completed cadaver study to further advance<br> the development of the percutaneous implantation technique for NeuroOne’s thin-film<br> paddle electrodes for spinal cord stimulation |
| --- | --- |
| ● | Presented<br> posters on pre-clinical experience with thin-film paddle leads at North American Neuromodulation<br> Society (NANS) and Gordon Research Conference on Neuroelectronic Interfaces |
| --- | --- |
Dave Rosa, CEO of NeuroOne, commented, “We made excellent progress this quarter across multiple fronts. Revenue growth continued regarding our sEEG product line as new customer sites were added by Zimmer Biomet. We also initiated the limited launch of the OneRF™ Ablation System, an exciting accomplishment given we are the first company to receive FDA 510(k) clearance to market this novel technology in the United States. Customer interest has been strong and we believe the OneRF™ Ablation System, with combination diagnostic and therapeutic functionality, has the capability to create a paradigm shift in neurosurgical procedures. Moving forward, we will investigate other applications to leverage our ablation system. We continue to believe strongly in the market opportunity for our drug delivery system as we believe it has the potential to create a unique platform for both identifying the target area in the brain, delivering the pharmacologic agent and monitoring its performance.”
KeyUpcoming Milestones
OneRF™ Ablation System:
| ● | Transition<br> manufacturing from sEEG diagnostic electrodes to OneRF electrodes |
|---|---|
| ● | Add<br> new centers for our limited commercial launch |
| --- | --- |
| ● | Exhibit<br> OneRF™ Ablation System and present posters at the 2024 American Society for Stereotactic<br> and Functional Neurosurgery (ASSFN) meeting in June |
| --- | --- |
| ● | Continue<br> to explore additional applications and strategic partnership opportunities for ablation in<br> neurology and other attractive markets that could benefit from NeuroOne’s high-resolution,<br> thin-film electrode technology |
| --- | --- |
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Drug Delivery Program:
| ● | Refine<br> prototype design and complete biocompatibility study |
|---|---|
| ● | Continue<br> to identify potential strategic partners to utilize NeuroOne’s drug delivery device<br> in clinical studies and research |
| --- | --- |
Spinal Cord Stimulation Program:
| ● | Finalize<br> electrode design |
|---|---|
| ● | Present<br> poster on feasibility of implantation of epidural thin-film paddle leads at International<br> Neuromodulation Society’s (INS) World Congress |
| --- | --- |
SecondQuarter Fiscal Year 2024 Financial Results
Product revenue was $1,377,000 in the second quarter of fiscal 2024, compared to product revenue of $466,000 in the second quarter of fiscal 2023. For the first six months of fiscal 2024, product revenue was $2,355,000, compared to $581,000 for the same period in fiscal 2023. The Company had no collaboration revenue in the first six months of fiscal 2024, compared to collaboration revenue of $1.46 million in the first six months of fiscal 2023. Collaboration revenue in 2023 was derived from the Zimmer Development Agreement and represents the portion of the exclusivity and milestone fee payments eligible for revenue recognition during the period.
Total operating expenses in the second quarter of fiscal 2024 were $3.3 million, compared with $3.5 million in the same period of the prior fiscal year. Research and Development (R&D) expense in the second quarter of fiscal 2024 was $1.3 million compared with $1.7 million in the second quarter of fiscal 2023. Selling, General and Administrative (SG&A) expense in the second quarter of fiscal 2024 was $2.0 million compared with $1.8 million in the prior year period. For the first six months of fiscal 2024, total operating expenses were $6.9 million, compared with $6.8 million in the same period of fiscal 2023. R&D expense in the first six months of fiscal 2024 was $2.8 million compared with $3.3 million in the same period of fiscal 2023. SG&A expense in the first six months of fiscal 2024 was $4.2 million compared with $3.5 million in the prior year period.
Net loss was $2.9 million for the second quarter of fiscal 2024, compared to a net loss of $3.5 million in the second quarter of fiscal 2023. Net loss for the first six months of fiscal 2024 was $6.2 million compared with $5.3 million in the same period of fiscal 2023.
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In the second quarter of fiscal 2024, the Company sold common stock under the ATM Program at an average price of $1.43 per share, from which the Company received net proceeds of $2.0 million.
As of March 31, 2024, the Company had cash and cash equivalents of $2.4 million, compared to $5.3 million as of September 30, 2023. The Company had working capital of $3.2 million as of March 31, 2024, compared to working capital of $5.5 million as of September 30, 2023.
The Company had no debt outstanding as of March 31, 2024.
ConferenceCall and Webcast
Tuesday, May 14, 2024 – 4:30 PM Eastern Time
Participant Dial-In:
888-506-0062 / +1 973-528-0011
Access Code:
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Live Webcast: ****
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Phone Replay:
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Webcast Replay:
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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.
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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 press release 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 transition of manufacturing from sEEG diagnostic electrodes to OneRF electrodes, the addition of new centers for the Company’s limited commercial launch, potential strategic partnership opportunities, continued development of the Company’s electrode technology program (including our drug delivery program and spinal cord stimulation program), 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 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
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NeuroOneMedical Technologies Corporation
CondensedBalance Sheets
(unaudited)
| As of<br> September 30, | |||||
|---|---|---|---|---|---|
| 2023 | |||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 2,434,655 | $ | 5,322,493 | ||
| Accounts receivable | 555,639 | — | |||
| Inventory | 1,311,673 | 1,726,686 | |||
| Prepaid expenses | 407,777 | 263,746 | |||
| Total current assets | 4,709,744 | 7,312,925 | |||
| Intangible assets, net | 78,419 | 89,577 | |||
| Right-of-use assets | 110,724 | 169,059 | |||
| Property and equipment, net | 496,015 | 525,753 | |||
| Total assets | 5,394,902 | $ | 8,097,314 | ||
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 780,839 | $ | 685,104 | ||
| Accrued expenses and other liabilities | 759,620 | 1,107,522 | |||
| Total current liabilities | 1,540,459 | 1,792,626 | |||
| Operating lease liability, long term | — | 55,284 | |||
| Total liabilities | 1,540,459 | 1,847,910 | |||
| Commitments and contingencies (Note 4) | |||||
| Stockholders’ equity: | |||||
| Preferred stock, 0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding. | — | — | |||
| Common stock, 0.001 par value; 100,000,000 shares authorized; 26,321,750 and 23,928,945 shares issued and outstanding as of March 31, 2024 and September 30, 2023, respectively. | 26,322 | 23,929 | |||
| Additional paid–in capital | 72,714,414 | 68,911,778 | |||
| Accumulated deficit | (68,886,293 | ) | (62,686,303 | ) | |
| Total stockholders’ equity | 3,854,443 | 6,249,404 | |||
| Total liabilities and stockholders’ equity | 5,394,902 | $ | 8,097,314 |
All values are in US Dollars.
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NeuroOneMedical Technologies Corporation
CondensedStatements of Operations
(unaudited)
| For the<br> Three Months Ended | For the<br><br>Six Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| March 31, | March 31, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Product revenue | $ | 1,377,294 | $ | 466,176 | $ | 2,354,943 | $ | 580,755 | ||||
| Cost of product revenue | 986,875 | 434,673 | 1,698,210 | 561,559 | ||||||||
| Product gross profit | 390,419 | 31,503 | 656,733 | 19,196 | ||||||||
| Collaborations revenue | — | — | — | 1,455,188 | ||||||||
| Operating expenses: | ||||||||||||
| Selling, general and administrative | 2,002,949 | 1,821,108 | 4,176,421 | 3,484,845 | ||||||||
| Research and development | 1,273,568 | 1,706,314 | 2,756,885 | 3,269,810 | ||||||||
| Total operating expenses | 3,276,517 | 3,527,422 | 6,933,306 | 6,754,655 | ||||||||
| Loss from operations | (2,886,098 | ) | (3,495,919 | ) | (6,276,573 | ) | (5,280,271 | ) | ||||
| Other income (expense), net | 31,008 | (26,909 | ) | 76,583 | 24,674 | |||||||
| Loss before income taxes | (2,855,090 | ) | (3,522,828 | ) | (6,199,990 | ) | (5,255,597 | ) | ||||
| Provision for income taxes | — | — | — | — | ||||||||
| Net loss | $ | (2,855,090 | ) | $ | (3,522,828 | ) | $ | (6,199,990 | ) | $ | (5,255,597 | ) |
| Net loss per share: | ||||||||||||
| Basic and diluted | $ | (0.11 | ) | $ | (0.21 | ) | $ | (0.25 | ) | $ | (0.32 | ) |
| Number of shares used in per share calculations: | ||||||||||||
| Basic and diluted | 25,910,478 | 16,414,795 | 24,947,813 | 16,321,891 |
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