NeuroOne® Issues Letter to Shareholders

Rhea-AI Summary

NeuroOne Medical Technologies (NMTC) has issued a shareholder letter highlighting recent achievements and future outlook. The company expanded its partnership with Zimmer Biomet, securing exclusive distribution rights for the OneRF® Ablation System with a $3.0 million upfront payment in November 2024.

The company recently raised $8.3 million from institutional investors, ensuring funding through fiscal 2026. NeuroOne confirmed no material impact from global tariffs due to its US-based supply chain. They plan to submit a 510(k) filing to FDA in May 2025 for trigeminal nerve ablation treatment.

For fiscal year 2025, NeuroOne projects product revenues of $8.0-$10.0 million (132%-190% increase from $3.5 million in FY2024) and improved gross margins of 47%-51% (up from 31% in FY2024). The company is also advancing its Spinal Cord Stimulation Program and sEEG-Based Drug Delivery Program, with strategic partnership discussions underway.

Positive

• Secured $8.3 million funding, ensuring operations through fiscal 2026
• Expanded Zimmer Biomet partnership with $3.0 million upfront payment
• Projected 132%-190% revenue growth to $8.0-$10.0 million in FY2025
• Expected gross margin improvement from 31% to 47%-51% in FY2025
• US-based supply chain eliminates tariff impact risks

Negative

• Recent share offering resulted in shareholder dilution

Company Now Fully Funded Through at least Fiscal 2026; Company Confirms No Material Impact from Global Tariffs

EDEN PRAIRIE, Minn., April 16, 2025 (GLOBE 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, has issued a letter to shareholders from CEO, Dave Rosa.

Dear Shareholders,

In recent months, NeuroOne has achieved several significant milestones, including the expansion of our commercial partnership with Zimmer Biomet, progress towards the submission of a 510(k) filing to treat facial pain, and continued product development momentum in areas of back pain management and drug delivery.

Most notably, the expansion of our partnership with Zimmer Biomet included exclusive distribution rights in the United States and certain additional countries for the OneRF^® Ablation System, which is the first and only FDA-cleared product that uses the same sEEG electrode for both diagnostic and therapeutic applications. The agreement included an upfront license payment of $3.0 million in November 2024 as well as established pricing and required product minimums.

Given the recent discussions around tariffs and global trade policy, we have also received questions regarding potential impacts on our supply chain. Investors should know that all of our key components are sourced and manufactured within the United States. Having a domestic-focused supply chain has been an intentional part of our operational strategy, and we do not anticipate any meaningful impact from current or proposed tariffs.

To execute on the opportunities in front of us, last week we successfully completed a capital raise with institutional investors totaling $8.3 million in net proceeds. Despite significant volatility across the broader capital markets, the offering was oversubscribed by well-respected financial institutions, did not include prohibitive and future dilutive financing mechanisms, and reflects continued institutional interest in our technology platform and long-term strategy.

With the proceeds from this offering, we believe the Company is now fully funded to operate through at least the end of fiscal year 2026, based on Zimmer making the minimum purchase requirements set forth in our expanded agreement. While our near-term focus remains on disciplined execution, if we achieve some of the key milestones currently in progress, we believe this capital could bring us to cash flow breakeven and support our long-term growth plans with no need for additional dilutive financing.

For instance, in March 2025, we accelerated the anticipated timeline of our 510(k) submission to the FDA for trigeminal nerve ablation to May 2025, which leverages the OneRF^® Technology Platform and will be used to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. With an estimated 100,000-200,000 patients suffering from facial pain in the U.S. alone, this market represents a significant opportunity for NeuroOne.

Other areas of growth include the Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program and the sEEG-Based Drug Delivery Program. Both are solutions that utilize the OneRF^® platform for pain management and drug delivery, respectively. We are in advanced discussions with strategic partners which would further validate our technology, provide significant reach, and potentially, include upfront payments.

Today, we stand as a larger, more mature company than ever before as we ramp revenues and product margins. We have a world class strategic partner, the necessary capital to execute on our strategic growth initiatives and several upcoming milestones that present significant opportunities to grow shareholder value.

As we look ahead, we are reiterating our fiscal year 2025 guidance, with product revenues expected to increase to between $8.0-$10.0 million, representing an increase of between 132%-190% when compared to product revenue of $3.5 million in fiscal year 2024, and expanded product gross margin of between 47%-51%, compared to product gross margin of 31% in fiscal year 2024.

Thank you for your unwavering support and being part of the NeuroOne story as we work to drive significant shareholder value and execute on the opportunities ahead of us.

Sincerely,

Dave Rosa
President & CEO

About NeuroOne

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) is developing and commercializing 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 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,” “forecasts,” “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 Company’s ability to be fully-funded through 2026; the continued development of the Company’s electrode technology program (including its drug delivery program and spinal cord stimulation program); the ability to achieve cash-flow break-even without additional dilutive financing; fiscal year 2025 guidance, including expectations for significant product revenue growth and margin expansion; the plan to submit a 510(k) application with the FDA in May 2025 for the Company’s trigeminal nerve ablation program; business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that it has a reasonable basis for each forward-looking statement, the Company cautions you that these statements are based on a combination of facts and factors currently known by the Company and its expectations of the future, about which the Company cannot be certain. Actual future results may be materially different from what the Company expects due to factors largely outside of its control, including risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements; risks that Zimmer may not purchase the minimum purchase requirements; risks that the Company’s strategic partnerships may not facilitate the commercialization or market acceptance of its technology; whether due to supply chain disruptions, labor shortages or otherwise; risks that the Company’s technology will not perform as expected; 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 Company may not be able to secure or retain coverage or adequate reimbursement for its technology; uncertainties inherent in the development process of the Company’s technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that the Company may not have accurately estimated the size and growth potential of the markets for its technology; risks that the Company may be unable to protect its intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in the Company’s 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.

IR Contact
MZ Group – MZ North America
NMTC@mzgroup.us

FAQ

What are NeuroOne's (NMTC) revenue projections for fiscal year 2025?

NeuroOne projects product revenues of $8.0-$10.0 million for FY2025, representing a 132%-190% increase from $3.5 million in FY2024.

How much funding did NMTC secure in their recent capital raise?

NeuroOne secured $8.3 million in net proceeds from institutional investors, funding operations through fiscal 2026.

What are the terms of NMTC's expanded partnership with Zimmer Biomet?

The partnership includes exclusive US distribution rights for OneRF® Ablation System, a $3.0 million upfront payment, and established pricing with required product minimums.

When will NMTC submit their 510(k) filing for trigeminal nerve ablation treatment?

NeuroOne plans to submit the 510(k) filing to FDA in May 2025 for trigeminal nerve ablation treatment.

What is the projected gross margin improvement for NMTC in fiscal 2025?

NeuroOne expects gross margins to expand to 47%-51% in FY2025, up from 31% in FY2024.