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NeuroOne® Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update

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NeuroOne Medical Technologies (NMTC) reported its Q3 fiscal year 2024 financial results and provided a corporate update. Key highlights include:

- Product revenue increased to $826,000 in Q3 2024, up from $630,000 in Q3 2023
- Operating expenses reduced from $3.8 million to $3.1 million year-over-year
- Completed first implants and ablations with OneRF™ Ablation System
- Signed non-binding term sheet for distribution partnership of OneRF™ Ablation System
- Raised $1.6 million through ATM Program in Q3 2024
- Completed $2.65 million private placement and secured $3.0 million credit facility in August 2024

The company continues to advance its product pipeline, including RF ablation applications, sEEG-based drug delivery, and a percutaneous paddle lead for spinal cord stimulation.

NeuroOne Medical Technologies (NMTC) ha riportato i risultati finanziari del terzo trimestre dell'anno fiscale 2024 e fornito un aggiornamento aziendale. Le principali novità includono:

- I ricavi da prodotto sono aumentati a 826.000 dollari nel Q3 2024, rispetto a 630.000 dollari nel Q3 2023
- Le spese operative sono diminuite da 3,8 milioni a 3,1 milioni di dollari rispetto all'anno precedente
- Completati i primi impianti e ablazioni con il sistema di ablazione OneRF™
- Firmato un contratto non vincolante per una partnership di distribuzione del sistema di ablazione OneRF™
- Raccolti 1,6 milioni di dollari attraverso il programma ATM nel Q3 2024
- Completato un collocamento privato di 2,65 milioni di dollari e assicurato un finanziamento di 3,0 milioni di dollari nell'agosto 2024

L'azienda continua a sviluppare la sua pipeline di prodotti, inclusi le applicazioni di ablazione RF, la somministrazione di farmaci basata su sEEG e un elettrodo a paddles per la stimolazione del midollo spinale.

NeuroOne Medical Technologies (NMTC) reportó los resultados financieros del tercer trimestre del año fiscal 2024 y proporcionó una actualización corporativa. Los aspectos más destacados incluyen:

- Los ingresos por productos aumentaron a 826,000 dólares en el Q3 2024, en comparación con 630,000 dólares en el Q3 2023
- Los gastos operativos se redujeron de 3.8 millones a 3.1 millones de dólares en comparación anual
- Se completaron los primeros implantes y ablaciones con el Sistema de Ablación OneRF™
- Se firmó un acuerdo no vinculante para una asociación de distribución del Sistema de Ablación OneRF™
- Se recaudaron 1.6 millones de dólares a través del programa ATM en el Q3 2024
- Se completó una colocación privada de 2.65 millones de dólares y se aseguró una línea de crédito de 3.0 millones de dólares en agosto de 2024

La empresa continúa avanzando en su cartera de productos, incluyendo aplicaciones de ablación RF, entrega de medicamentos basada en sEEG y un electrodo de pala percutáneo para estimulación de la médula espinal.

NeuroOne Medical Technologies(NMTC)는 2024회계연도 3분기 재무 결과를 발표하고 회사 업데이트를 제공했습니다. 주요 사항은 다음과 같습니다:

- 제품 수익이 2024년도 3분기에 826,000달러로 증가하여 2023년도 3분기의 630,000달러에서 상승하였습니다.
- 운영 비용이 3.8백만 달러에서 3.1백만 달러로 연간 감소하였습니다.
- OneRF™ 절제 시스템을 사용한 첫 번째 임플란트 및 절제를 완료하였습니다.
- OneRF™ 절제 시스템의 유통 파트너십을 위한 비구속적인 조건서를 체결하였습니다.
- 2024 3분기에 ATM 프로그램을 통해 1.6백만 달러를 모금하였습니다.
- 2024년 8월에 265만 달러의 사모 발행을 완료하고 300만 달러의 신용을 확보하였습니다.

회사는 RF 절제 응용 프로그램, sEEG 기반 약물 전달 및 척수 자극을 위한 경피성 패들 리드 등을 포함한 제품 파이프라인을 지속적으로 발전시키고 있습니다.

NeuroOne Medical Technologies (NMTC) a annoncé ses résultats financiers pour le troisième trimestre de l'exercice 2024 et fourni une mise à jour de l'entreprise. Les faits saillants incluent:

- Les revenus produits ont augmenté à 826 000 dollars au T3 2024, contre 630 000 dollars au T3 2023
- Les dépenses opérationnelles sont passées de 3,8 millions à 3,1 millions de dollars par rapport à l'année précédente
- Premiers implants et ablations réalisés avec le système d'ablation OneRF™
- Un protocole d'accord non contraignant pour un partenariat de distribution du système d'ablation OneRF™ a été signé
- 1,6 million de dollars ont été levés par le biais du programme ATM au T3 2024
- Une levée de fonds privée de 2,65 millions de dollars a été réalisée et un financement de 3,0 millions de dollars a été sécurisé en août 2024

L'entreprise continue à faire avancer son pipeline de produits, y compris des applications d'ablation RF, la délivrance de médicaments basée sur le sEEG, et un électrode à palette percutanée pour la stimulation de la moelle épinière.

NeuroOne Medical Technologies (NMTC) hat die finanziellen Ergebnisse des dritten Quartals des Geschäftsjahres 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Die wichtigsten Highlights sind:

- Die Produktumsätze stiegen im Q3 2024 auf 826.000 Dollar, verglichen mit 630.000 Dollar im Q3 2023
- Die Betriebskosten wurden im Jahresvergleich von 3,8 Millionen auf 3,1 Millionen Dollar gesenkt
- Die ersten Implantate und Ablationen mit dem OneRF™-Ablationssystem wurden abgeschlossen
- Ein nicht verbindliches Eckpunktepapier für eine Vertriebskooperation des OneRF™-Ablationssystems wurde unterzeichnet
- Im Q3 2024 wurden 1,6 Millionen Dollar durch das ATM-Programm eingesammelt
- Eine private Platzierung über 2,65 Millionen Dollar abgeschlossen und im August 2024 eine Kreditlinie über 3,0 Millionen Dollar gesichert

Das Unternehmen setzt seine Arbeiten an der Produktpipeline fort, einschließlich RF-Ablationsanwendungen, sEEG-gestützter Medikamentenverabreichung und einem perkutanen Paddle-Elektrode zur Rückenmarks-Stimulation.

Positive
  • Product revenue increased 31% year-over-year to $826,000 in Q3 2024
  • Operating expenses reduced by 18% to $3.1 million in Q3 2024
  • Completed first implants and ablations with OneRF™ Ablation System
  • Signed non-binding term sheet for distribution partnership of OneRF™ Ablation System
  • Raised $1.6 million through ATM Program in Q3 2024
  • Completed $2.65 million private placement and secured $3.0 million credit facility in August 2024
  • New ICD-10-PCS code approved for OneRF™ ablation procedure, effective October 1, 2024
Negative
  • Net loss of $2.8 million in Q3 2024, compared to $3.5 million in Q3 2023
  • Cash and cash equivalents decreased to $1.6 million as of June 30, 2024, from $5.3 million as of September 30, 2023
  • Working capital decreased to $2.2 million as of June 30, 2024, from $5.5 million as of September 30, 2023
  • No collaboration revenue in the first nine months of fiscal 2024, compared to $1.46 million in the same period of fiscal 2023

Insights

NeuroOne's Q3 2024 results show mixed signals. The company's $826,000 product revenue represents a 31% year-over-year increase, indicating growing market traction. However, the net loss of $2.8 million, although improved from last year, remains significant.

The reduction in operating expenses from $3.8 million to $3.1 million is positive, showing effective cost management. The recent $2.65 million private placement and $3 million credit facility provide short-term financial stability, but long-term profitability remains uncertain.

Investors should monitor the progress of the OneRF™ Ablation System and potential strategic partnerships, as these could be key drivers for future growth and profitability.

NeuroOne's progress with the OneRF™ Ablation System is promising. The completion of first implants and ablations, along with training at multiple sites, indicates market readiness. The new ICD-10-PCS code for the OneRF™ procedure, effective October 2024, is a significant milestone that should facilitate adoption and reimbursement.

The company's diversified pipeline, including sEEG-based drug delivery and spinal cord stimulation, demonstrates potential for long-term growth. However, these programs are still in early stages and require substantial development before commercialization.

The potential distribution partnership for OneRF™ could accelerate market penetration, but investors should await finalized agreements before factoring this into valuations.

NeuroOne's focus on the neurological disorders market positions it in a growing sector. The successful implementation of OneRF™ Ablation System in initial cases and ongoing discussions with potential partners indicate positive market reception.

The company's strategy of targeting multiple applications (ablation, drug delivery, spinal cord stimulation) with its thin-film electrode technology could provide diverse revenue streams. However, competition in these markets is intense and NeuroOne will need to demonstrate clear clinical and economic benefits to gain significant market share.

The potential distribution partnership for OneRF™ could be a game-changer, potentially providing access to a larger sales network and accelerating market penetration. Investors should closely monitor the finalization of this agreement and its terms.

EDEN PRAIRIE, Minn., Aug. 14, 2024 (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, today announces its operating results for the third quarter fiscal year 2024 ended June 30, 2024.

Third Quarter Fiscal Year 2024 and Recent Business Updates

Financial Highlights:

  • Product revenue of $826,000 in Q3 2024, compared to $630,000 in Q3 2023
  • Reduced operating expenses from $3.8 million in Q3 2023 to $3.1 million in Q3 2024
  • Raised an additional $1.6 million using the ATM Program in Q3 2024
  • Completed $2.65 million private placement and entered into $3.0 million secured credit facility agreement in August 2024

Evo® sEEG:

  • Completed manufacturing transition from sEEG diagnostic electrodes to OneRF electrodes

OneRF Ablation System:

  • Continued limited commercial launch of the OneRF Ablation System, including first shipments, implants and ablations with OneRF Ablation System
  • Completed OneRF Ablation System training for four sites and initiated sales quote process with 12 additional sites
  • Implanted ~200 RF electrodes and performed more than 50 RF ablations on 3 patients
  • Signed a non-binding term sheet with an undisclosed global medical technology company to distribute our OneRF Ablation System. The term sheet is non-binding, and the partnership is subject to the negotiation and execution of definitive documentation, due diligence, and other customary closing conditions
  • Exhibited the OneRF Ablation System at the Association of Neurological Surgeons (AANS) Annual Scientific Meeting in May and the American Society for Stereotactic and Functional Neurosurgery Biennial Meeting in June
  • The Centers for Medicare and Medicaid Services (CMS) approved and granted a new ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) code for the OneRF ablation procedure. The new code will be effective October 1, 2024 and allows hospital reporting of inpatient procedures that are performed using the OneRF Ablation System ensuring efficient and accurate documentation, billing, and analysis
  • Presented posters on preclinical evaluation and ex vivo lesion characterization of OneRF Ablation System at the AANS Annual Scientific Meeting in May

sEEG-Based Drug Delivery Program:

  • Completed feasibility testing in vivo study providing histology data
  • Completed drug compatibility and adsorption testing
  • Presented posters on feasibility bench testing and in vivo studies of sEEG-based drug delivery into the brain at the American Association of Pharmaceutical Scientists (AAPS-NBC) and the American Society of Gene & Cell Therapy (ASGCT) in May
  • Continued discussions with potential targeted strategic partners for use in clinical studies and research

Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program:

  • Successfully completed acute animal study in large animal model to evaluate stimulation performance of our percutaneous paddle lead for back and neck pain
  • Successfully completed cadaver lab with physician key opinion leaders to further advance the development of a percutaneous implantation technique for our thin-film SCS percutaneous paddle electrodes
  • Finalized NeuroOne paddle lead design, including testing of electrode specifications
  • Filed a provisional patent on a connector that is compatible with our thin-film SCS electrodes

Dave Rosa, CEO of NeuroOne, commented, “We accomplished several key milestones this quarter. We are most excited about completing the first RF ablation cases with our first-to-market OneRF Ablation System. We also signed a non-binding term sheet with a large strategic partner to serve as our distribution partner and accelerate the launch of the OneRF Ablation System. In August, we completed a financing, entered into a credit facility agreement, and are making good progress with our product pipeline, including additional RF ablation applications, sEEG-based drug delivery and a percutaneous paddle lead for spinal cord stimulation. We are looking forward to securing additional strategic partners for these exciting programs leveraging our thin-film electrode platform technology.”

Key Upcoming Milestones

OneRF Ablation System:

  • Finalize strategic partnership for distribution of OneRF Ablation System
  • Continue to add new centers for our limited commercial launch
  • Exhibit OneRF Ablation System at the 2024 World Congress of Stereotactic and Functional Neurosurgery meeting in September
  • Present posters on OneRF Ablation System at the Congress of Neurological Surgeons 2024 annual meeting in September
  • Continue to explore additional ablation applications and strategic partnership opportunities in other attractive markets that could benefit from NeuroOne’s high-resolution, thin-film electrode technology and RF generator

Spinal Cord Stimulation Percutaneous Paddle Lead Program:

  • Initiate discussions with potential strategic partners to license or acquire the NeuroOne Spinal Cord Stimulation percutaneous paddle lead product

Third Quarter Fiscal Year 2024 Financial Results

Product revenue was $826,000 in the third quarter of fiscal 2024, compared to product revenue of $630,000 in the third quarter of fiscal 2023. For the first nine months of fiscal 2024, product revenue was $3.2 million, compared to $1.2 million for the same period in fiscal 2023. The Company had no collaboration revenue in the first nine months of fiscal 2024, compared to collaboration revenue of $1.46 million in the first nine 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 third quarter of fiscal 2024 were $3.1 million, compared with $3.8 million in the same period of the prior fiscal year. Research and Development (R&D) expense in the third quarter of fiscal 2024 was $1.2 million compared with $1.9 million in the third quarter of fiscal 2023. Selling, General and Administrative (SG&A) expenses were $1.9 million during each of the three months ended June 30, 2024 and 2023. For the first nine months of fiscal 2024, total operating expenses were $10.0 million, compared with $10.5 million in the same period of fiscal 2023. R&D expense in the first nine months of fiscal 2024 was $4.0 million compared with $5.2 million in the same period of fiscal 2023. SG&A expense in the first nine months of fiscal 2024 was $6.1 million compared with $5.3 million in the prior year period.

Net loss was $2.8 million for the third quarter of fiscal 2024, compared to a net loss of $3.5 million in the third quarter of fiscal 2023. Net loss for the first nine months of fiscal 2024 was $9.0 million compared with $8.7 million in the same period of fiscal 2023.

In the third quarter of fiscal 2024, the Company sold common stock under the ATM Program at an average price of $1.19 per share, from which the Company received net proceeds of $1.6 million.

As of June 30, 2024, the Company had cash and cash equivalents of $1.6 million, compared to $5.3 million as of September 30, 2023. The Company had working capital of $2.2 million as of June 30, 2024, compared to working capital of $5.5 million as of September 30, 2023.

The Company had no debt outstanding as of June 30, 2024.

On August 2, 2024, the Company completed a $2.65 million private placement, resulting in $2.55 million in net proceeds, and entered into a $3.0 million secured credit facility agreement. The Company has not borrowed anything under the credit facility agreement at this time.

Conference Call and Webcast

Wednesday, August 14, 2024, at 4:30 PM Eastern Time

Participants:

Toll Free: 877-545-0320
International: 973-528-0002
Participant Access Code: 579769

Phone Replay:

Toll Free: 877-481-4010
International: 919-882-2331
Replay Passcode: 51065
Available through August 28, 2024

Live Webcast: 

Join here.
Webcast replay available for 12 months

About NeuroOne

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.

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,” “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 securing a strategic partnership for distribution of the OneRF Ablation System, the addition of new centers for the Company’s limited commercial launch of the OneRF Ablation System, 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 our strategic partnerships 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

NeuroOne Medical Technologies Corporation
Condensed Balance Sheets

  As of
June 30,
  As of
September 30,
 
  2024  2023 
  (unaudited)    
Assets      
Current assets:      
Cash and cash equivalents $1,619,977  $5,322,493 
Accounts receivable  410,551    
Inventory  1,793,432   1,726,686 
Prepaid expenses  261,477   263,746 
Total current assets  4,085,437   7,312,925 
Intangible assets, net  72,841   89,577 
Right-of-use assets  281,833   169,059 
Property and equipment, net  472,486   525,753 
Total assets $4,912,597  $8,097,314 
         
Liabilities and Stockholders’ Equity        
Current liabilities:        
Accounts payable $759,260  $685,104 
Accrued expenses and other liabilities  931,700   1,107,522 
Total current liabilities  1,690,960   1,792,626 
Operating lease liability, long term  209,910   55,284 
Total liabilities  1,900,870   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; 27,846,722 and 23,928,945 shares issued and outstanding as of June 30, 2024 and September 30, 2023, respectively.  27,847   23,929 
Additional paid–in capital  74,637,698   68,911,778 
Accumulated deficit  (71,653,818)  (62,686,303)
Total stockholders’ equity  3,011,727   6,249,404 
Total liabilities and stockholders’ equity $4,912,597  $8,097,314 


NeuroOne Medical Technologies Corporation

Condensed Statements of Operations
(unaudited)

  For the
Three Months Ended
  For the
Nine Months Ended
 
  June 30,  June 30, 
  2024  2023  2024  2023 
Product revenue $825,776  $629,906  $3,180,719  $1,210,661 
Cost of product revenue  543,904   386,240   2,242,114   947,799 
Product gross profit  281,872   243,666   938,605   262,862 
                 
Collaborations revenue           1,455,188 
                 
Operating expenses:                
Selling, general and administrative  1,881,099   1,862,389   6,057,520   5,347,234 
Research and development  1,194,674   1,891,512   3,951,559   5,161,322 
Total operating expenses  3,075,773   3,753,901   10,009,079   10,508,556 
Loss from operations  (2,793,901)  (3,510,235)  (9,070,474)  (8,790,506)
Other income, net  26,376   41,462   102,959   66,136 
Loss before income taxes  (2,767,525)  (3,468,773)  (8,967,515)  (8,724,370)
Provision for income taxes            
Net loss $(2,767,525) $(3,468,773) $(8,967,515) $(8,724,370)
                 
Net loss per share:                
Basic and diluted $(0.10) $(0.20) $(0.35) $(0.52)
Number of shares used in per share calculations:                
Basic and diluted  27,352,660   17,578,871   25,746,503   16,740,546 

FAQ

What was NeuroOne's (NMTC) product revenue in Q3 2024?

NeuroOne's product revenue in Q3 2024 was $826,000, an increase from $630,000 in Q3 2023.

How much did NeuroOne (NMTC) raise through its ATM Program in Q3 2024?

NeuroOne raised an additional $1.6 million using the ATM Program in Q3 2024.

What is the status of NeuroOne's (NMTC) OneRF™ Ablation System?

NeuroOne has begun a commercial launch of the OneRF™ Ablation System, including first shipments, implants, and ablations. The company has also signed a non-binding term sheet for a distribution partnership.

What financing did NeuroOne (NMTC) secure in August 2024?

In August 2024, NeuroOne completed a $2.65 million private placement and entered into a $3.0 million secured credit facility agreement.

NeuroOne Medical Technologies Corporation

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0.42%
Medical Devices
Surgical & Medical Instruments & Apparatus
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EDEN PRAIRIE