Autonomix Medical, Inc. Reports Third Quarter Fiscal Year 2025 Financial Results and Provides a Corporate Update
Autonomix Medical (NASDAQ: AMIX) reported Q3 FY2025 financial results and corporate updates. The company is advancing its proof-of-concept clinical trial for pancreatic cancer pain treatment, with topline data expected in 1H 2025. Key achievements include expanding intellectual property, strengthening regulatory teams, and achieving design lock for RF ablation catheter.
Financial highlights show a net loss of $2.7 million for Q3, compared to $3.1 million in the previous year. The company secured a $10 million public offering to extend its cash runway. R&D expenses increased to $1.0 million from $0.7 million year-over-year, while G&A expenses decreased to $1.7 million from $2.2 million.
The company's technology platform features a catheter-based microchip sensing array with 3,000 times greater sensitivity than current technologies. Autonomix aims for potential FDA clearance by 2027, with US clinical trials planned for 2025.
Autonomix Medical (NASDAQ: AMIX) ha riportato i risultati finanziari del terzo trimestre dell'anno fiscale 2025 e aggiornamenti aziendali. L'azienda sta avanzando con il suo studio clinico di prova di concetto per il trattamento del dolore nel cancro pancreatico, con i dati preliminari attesi nella prima metà del 2025. Tra i risultati chiave ci sono l'espansione della proprietà intellettuale, il rafforzamento dei team normativi e il raggiungimento del design lock per il catetere di ablazione RF.
I risultati finanziari mostrano una perdita netta di 2,7 milioni di dollari per il terzo trimestre, rispetto ai 3,1 milioni dell'anno precedente. L'azienda ha assicurato un offerta pubblica di 10 milioni di dollari per estendere la sua liquidità. Le spese per R&S sono aumentate a 1,0 milioni di dollari rispetto ai 0,7 milioni dell'anno precedente, mentre le spese generali e amministrative sono diminuite a 1,7 milioni di dollari rispetto ai 2,2 milioni.
La piattaforma tecnologica dell'azienda presenta un array di sensori microchip basato su catetere con una sensibilità 3.000 volte superiore rispetto alle tecnologie attuali. Autonomix punta a una potenziale approvazione da parte della FDA entro il 2027, con studi clinici negli Stati Uniti previsti per il 2025.
Autonomix Medical (NASDAQ: AMIX) informó sobre los resultados financieros del tercer trimestre del año fiscal 2025 y actualizaciones corporativas. La empresa está avanzando en su ensayo clínico de prueba de concepto para el tratamiento del dolor en el cáncer de páncreas, con datos preliminares esperados en la primera mitad de 2025. Los logros clave incluyen la expansión de la propiedad intelectual, el fortalecimiento de los equipos regulatorios y la consecución del bloqueo de diseño para el catéter de ablación RF.
Los aspectos financieros muestran una pérdida neta de 2,7 millones de dólares en el tercer trimestre, en comparación con 3,1 millones del año anterior. La empresa aseguró una oferta pública de 10 millones de dólares para extender su liquidez. Los gastos en I+D aumentaron a 1,0 millones de dólares desde 0,7 millones del año anterior, mientras que los gastos generales y administrativos disminuyeron a 1,7 millones de dólares desde 2,2 millones.
La plataforma tecnológica de la empresa cuenta con un array de sensores microchip basado en catéter con una sensibilidad 3,000 veces mayor que las tecnologías actuales. Autonomix aspira a una posible aprobación de la FDA para 2027, con ensayos clínicos en EE.UU. planeados para 2025.
Autonomix Medical (NASDAQ: AMIX)는 2025 회계연도 3분기 재무 결과 및 기업 업데이트를 발표했습니다. 이 회사는 췌장암 통증 치료를 위한 개념 검증 임상 시험을 진행 중이며, 주요 데이터는 2025년 상반기에 예상됩니다. 주요 성과로는 지적 재산권 확대, 규제 팀 강화, RF 절제 카테터의 설계 잠금 달성이 있습니다.
재무 하이라이트에 따르면 3분기 동안 270만 달러의 순손실을 기록했으며, 이는 지난해 310만 달러에 비해 감소한 수치입니다. 이 회사는 현금 유동성을 연장하기 위해 1천만 달러의 공모를 확보했습니다. 연구개발 비용은 전년 대비 70만 달러에서 100만 달러로 증가했으며, 일반 관리 비용은 220만 달러에서 170만 달러로 감소했습니다.
회사의 기술 플랫폼은 현재 기술보다 3,000배 더 높은 감도를 가진 카테터 기반의 마이크로칩 센서 배열을 특징으로 합니다. Autonomix는 2027년까지 FDA 승인을 목표로 하며, 2025년에는 미국에서 임상 시험을 계획하고 있습니다.
Autonomix Medical (NASDAQ: AMIX) a publié ses résultats financiers pour le troisième trimestre de l'exercice 2025 ainsi que des mises à jour de l'entreprise. La société fait avancer son essai clinique de preuve de concept pour le traitement de la douleur liée au cancer du pancréas, avec des données préliminaires attendues au cours de la première moitié de 2025. Parmi les réalisations clés figurent l'expansion de la propriété intellectuelle, le renforcement des équipes réglementaires et l'obtention du verrouillage de conception pour le cathéter d'ablation RF.
Les points financiers montrent une perte nette de 2,7 millions de dollars pour le troisième trimestre, contre 3,1 millions de dollars l'année précédente. L'entreprise a sécurisé une offre publique de 10 millions de dollars pour prolonger sa liquidité. Les dépenses de R&D ont augmenté à 1,0 million de dollars contre 0,7 million de dollars l'année précédente, tandis que les dépenses générales et administratives ont diminué à 1,7 million de dollars contre 2,2 millions de dollars.
La plateforme technologique de l'entreprise dispose d'un réseau de capteurs microchip basé sur un cathéter avec une sensibilité 3 000 fois supérieure à celle des technologies actuelles. Autonomix vise une éventuelle approbation par la FDA d'ici 2027, avec des essais cliniques prévus aux États-Unis pour 2025.
Autonomix Medical (NASDAQ: AMIX) hat die Finanzzahlen für das dritte Quartal des Geschäftsjahres 2025 und Unternehmensupdates veröffentlicht. Das Unternehmen entwickelt seine Machbarkeitsstudie zur Schmerzbehandlung bei Bauchspeicheldrüsenkrebs weiter, wobei die vorläufigen Daten in der ersten Hälfte von 2025 erwartet werden. Zu den wichtigsten Erfolgen gehören die Erweiterung des geistigen Eigentums, die Stärkung der Regulierungs-Teams und der Erhalt des Design-Locks für den RF-Ablationskatheter.
Die finanziellen Höhepunkte zeigen einen Nettoverlust von 2,7 Millionen Dollar für das dritte Quartal, verglichen mit 3,1 Millionen Dollar im Vorjahr. Das Unternehmen sicherte sich eine Öffentliche Platzierung von 10 Millionen Dollar, um seine Liquidität zu verlängern. Die F&E-Ausgaben stiegen von 0,7 Millionen Dollar im Vorjahr auf 1,0 Millionen Dollar, während die allgemeinen und administrativen Ausgaben von 2,2 Millionen Dollar auf 1,7 Millionen Dollar sanken.
Die Technologieplattform des Unternehmens umfasst ein katheterbasiertes Mikrochip-Sensorarray mit einer um das 3.000-fache höheren Empfindlichkeit als die aktuellen Technologien. Autonomix strebt eine mögliche FDA-Zulassung bis 2027 an, mit klinischen Studien in den USA, die für 2025 geplant sind.
- Secured $10 million through public offering to extend cash runway
- Reduced quarterly net loss to $2.7M from $3.1M year-over-year
- Decreased G&A expenses by $0.5M compared to previous year
- Achieved design lock for RF ablation catheter
- Increased R&D expenses by $0.3M compared to previous year
- Operating cash burn increased to $5.7M from $4.4M for nine-month period
- Nine-month G&A expenses increased by $1.6M year-over-year
Insights
The Q3 FY2025 results demonstrate Autonomix Medical's careful balance between technological advancement and financial management. The company's $11.8M cash position, bolstered by a $10M public offering, provides an estimated 12-18 month runway based on the current quarterly burn rate of approximately
The 33% year-over-year increase in R&D spending to
Critical operational achievements include:
- Design lock for RF ablation catheter and ASIC microchip, reducing technical risk and accelerating commercialization timeline
- Expanded IP protection through new US patent grant
- Strengthened regulatory team ahead of anticipated FDA submission
The upcoming proof-of-concept trial results in 1H 2025 represent a important catalyst. Positive data could accelerate the pathway to the planned 2027 FDA clearance and validate the company's precision nerve-targeting approach. The reduction in G&A expenses by
Ongoing proof-of-concept (PoC) clinical trial in pain associated with pancreatic cancer with topline data on track for 1H 2025
Continued solid execution on milestones with several design locks and key development objectives met in the quarter
Company remains on track to submit an Investigational Device Exemption (“IDE”), and if approved, will initiate US clinical trials in 2025 to support a De Novo application for FDA approval
THE WOODLANDS, TX, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today reported financial results for the third quarter fiscal year 2025 ended December 31, 2024 and provided a corporate update.
Quarter Highlights
- Expanded intellectual property estate with U.S. patent grant covering technology including, but not limited to, systems, methods and devices for transvascular treatment of cancerous tumors and cancer related pain;
- Bolstered regulatory and quality team to support clinical and regulatory initiatives in anticipation of FDA approval process;
- Achieved design lock for radio frequency (“RF”) ablation catheter following successful completion of animal testing; and
- Extended cash runway with
$10 million underwritten public offering, before deducting underwriter discounts and other financing expenses, including partial exercise of over-allotment option.
“We are making significant progress across multiple fronts and remain fully focused and committed to executing on our strategic priorities. On the clinical front, we remain on track to report topline data from our PoC trial in the first half of 2025 and have made significant progress toward initiating studies in the US in the second half of this year, which will be used in our regulatory filings to obtain a potential clearance for pancreatic cancer pain in 2027. We have achieved design lock for our ASIC microchip and RF ablation catheter, which represent key milestones in the advancement of our innovative technology,” commented Brad Hauser, Chief Executive Officer of Autonomix. “With important key data readouts on the horizon and continued progress toward potential FDA approval, we believe we are positioned for a strong year ahead. We hope to leverage this momentum to drive long-term value for our shareholders.”
The Company’s first-in-class technology platform utilizes a catheter-based microchip sensing array antenna that has the ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than currently available technologies. Once target nerves are identified, Autonomix uses its proprietary RF ablation technology to kill targeted nerves, enabling a precision guided sense, treat and verify approach to addressing a number of disease categories from chronic pain management to hypertension and cardiology. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects.
Expected Upcoming Milestones
- 1H 2025: Report topline data from PoC trial
- 2025: Initiate clinical trials in the United States
- 2026: Report topline data from US human trials
- 2026: De novo submission
- 2027: Potential FDA clearance
For more information about the Company’s technology, please visit autonomix.com.
Summary of Financial Results for Three and Nine Months Ended December 31, 2024
For the three months ended December 31, 2024 and 2023, the Company incurred net losses of
General and administrative expense was
Research and development expense was
For the nine months ended December 31, 2024 and 2023, the Company incurred net losses of
General and administrative expense was
Research and development expense was
As of December 31, 2024, the Company had cash of
About Autonomix Medical, Inc.
Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.
We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.
For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
Forward Looking Statements
Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the events set forth in the section “Expected Upcoming Milestones”, the potential of the technology to treat pain associated with pancreatic cancer, to successfully enroll patients within the specific timeframe, and to complete its clinical study in pancreatic cancer pain. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”
Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on May 31, 2024 and the Offering Prospectus filed with the SEC on November 25, 2024, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
FAQ
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