ENDRA Life Sciences Reports Second Quarter 2024 Financial Results and Provides a Business Update
ENDRA Life Sciences (NASDAQ: NDRA) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. New executive team: Alexander Tokman appointed as acting CEO, along with new CFO and Head of Regulatory and Clinical Affairs.
2. Clinical and regulatory progress: Advanced U.S. FDA process, initiated new pilot clinical trials, and expanded patent portfolio to 81 issued patents globally.
3. Financial updates: Raised $8.0 million in a public offering and reduced annualized operating expenses by $3.1 million.
4. Q2 2024 financials: Operating expenses decreased to $2.2 million from $3.0 million in Q2 2023. Cash and cash equivalents were $6.4 million as of June 30, 2024.
The company is prioritizing clinical data collection for a new De Novo FDA filing and revisiting its go-to-market strategy for TAEUS technology.
ENDRA Life Sciences (NASDAQ: NDRA) ha pubblicato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. Nuovo team esecutivo: Alexander Tokman è stato nominato CEO ad interim, insieme al nuovo CFO e al Responsabile delle Affari Regolatori e Clinici.
2. Progresso clinico e regolamentare: Avanzamento del processo presso la FDA degli Stati Uniti, avviati nuovi studi clinici pilota e ampliato il portafoglio di brevetti a 81 brevetti concessi a livello globale.
3. Aggiornamenti finanziari: Raccolti 8,0 milioni di dollari in un'offerta pubblica e ridotti i costi operativi annualizzati di 3,1 milioni di dollari.
4. Finanziari del Q2 2024: Le spese operative sono scese a 2,2 milioni di dollari rispetto ai 3,0 milioni di dollari nel secondo trimestre 2023. Liquidità e equivalenti erano di 6,4 milioni di dollari al 30 giugno 2024.
L'azienda sta dando priorità alla raccolta di dati clinici per una nuova presentazione De Novo alla FDA e sta rivedendo la sua strategia di ingresso nel mercato per la tecnologia TAEUS.
ENDRA Life Sciences (NASDAQ: NDRA) reportó los resultados financieros del segundo trimestre de 2024 y brindó una actualización empresarial. Los aspectos más destacados incluyen:
1. Nuevo equipo ejecutivo: Alexander Tokman fue nombrado CEO interino, junto con un nuevo CFO y un Responsable de Asuntos Regulatorios y Clínicos.
2. Progreso clínico y regulatorio: Avance en el proceso de la FDA de EE. UU., iniciados nuevos ensayos clínicos piloto y ampliado el portafolio de patentes a 81 patentes emitidas a nivel mundial.
3. Actualizaciones financieras: Se recaudaron 8,0 millones de dólares en una oferta pública y se redujeron los gastos operativos anuales en 3,1 millones de dólares.
4. Financieros del Q2 2024: Los gastos operativos disminuyeron a 2,2 millones de dólares desde 3,0 millones de dólares en el Q2 2023. El efectivo y equivalentes eran de 6,4 millones de dólares al 30 de junio de 2024.
La empresa está priorizando la recopilación de datos clínicos para una nueva presentación De Novo ante la FDA y revisando su estrategia de comercialización para la tecnología TAEUS.
ENDRA Life Sciences (NASDAQ: NDRA)는 2024년 2분기 재무 결과를 보고하고 비즈니스 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:
1. 새로운 경영진: Alexander Tokman이 임시 CEO로 임명되었으며, 새로운 CFO와 규제 및 임상 업무 책임자도 지명되었습니다.
2. 임상 및 규제 진행 상황: 미국 FDA 프로세스가 진전되었고, 새로운 파일럿 임상 시험이 시작되었으며, 전 세계적으로 81개의 특허를 보유하게 되었습니다.
3. 재무 업데이트: 공모를 통해 800만 달러를 모금하였고, 연간 운영 비용이 310만 달러 감소하였습니다.
4. 2024년 2분기 재무: 운영 비용이 300만 달러에서 220만 달러로 감소했습니다. 2024년 6월 30일 기준으로 현금 및 현금성 자산은 640만 달러입니다.
회사는 새로운 De Novo FDA 제출을 위한 임상 데이터 수집을 우선시하고 TAEUS 기술에 대한 시장 진입 전략을 재검토하고 있습니다.
ENDRA Life Sciences (NASDAQ: NDRA) a rapporté les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les faits marquants comprennent :
1. Nouvelle équipe exécutive : Alexander Tokman a été nommé PDG par intérim, avec un nouveau CFO et un Responsable des Affaires Réglementaires et Cliniques.
2. Progrès clinique et réglementaire : Avancement du processus auprès de la FDA des États-Unis, lancement de nouveaux essais cliniques pilotes et élargissement du portefeuille de brevets à 81 brevets délivrés au niveau mondial.
3. Mises à jour financières : 8,0 millions de dollars levés lors d'une offre publique et réduction des dépenses d'exploitation annualisées de 3,1 millions de dollars.
4. Finances du T2 2024 : Les dépenses d'exploitation ont diminué à 2,2 millions de dollars contre 3,0 millions de dollars au T2 2023. La trésorerie et équivalents s'élevaient à 6,4 millions de dollars au 30 juin 2024.
L'entreprise privilégie la collecte de données cliniques pour un nouveau dépôt De Novo auprès de la FDA et revoit sa stratégie de mise sur le marché pour la technologie TAEUS.
ENDRA Life Sciences (NASDAQ: NDRA) hat die Finanzzahlen für das 2. Quartal 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Zu den wichtigsten Highlights gehören:
1. Neues Führungsteam: Alexander Tokman wurde zum amtierenden CEO ernannt, zusammen mit einem neuen CFO und einem Leiter der regulatorischen und klinischen Angelegenheiten.
2. Klinische und regulatorische Fortschritte: Fortgeschrittener Prozess bei der US FDA, Initiierung neuer Pilotstudien und Erweiterung des Patentportfolios auf weltweit 81 erteilte Patente.
3. Finanzielle Updates: 8,0 Millionen Dollar in einer öffentlichen Angebotssammlung eingenommen und die jährlichen Betriebskosten um 3,1 Millionen Dollar reduziert.
4. Finanzen Q2 2024: Die Betriebskosten sanken im Vergleich zu 3,0 Millionen Dollar im 2. Quartal 2023 auf 2,2 Millionen Dollar. Bargeld und Zahlungsmitteläquivalente beliefen sich am 30. Juni 2024 auf 6,4 Millionen Dollar.
Das Unternehmen priorisiert die Sammlung klinischer Daten für einen neuen De Novo FDA-Antrag und überprüft seine Markteinführungsstrategie für die TAEUS-Technologie.
- Appointment of experienced executives to key leadership positions
- Progress in FDA regulatory process with alignment on steps for successful outcome
- Initiation of new pilot clinical trials in North America and Europe
- Expansion of patent portfolio with 5 additional patents issued
- Successful capital raise of $8.0 million through public offering
- Reduction of annualized operating expenses by $3.1 million (26%)
- Decrease in Q2 2024 operating expenses to $2.2 million from $3.0 million in Q2 2023
- Shift in focus from development to clinical activities, potentially slowing product development
- Continued operating losses, as evidenced by the need for additional capital raise
ENDRA Life Sciences' Q2 2024 results reveal a mixed financial picture. The company has taken significant steps to strengthen its financial position and reduce expenses. Key points include:
- Raised
$8.0 million in gross proceeds through a public offering - Reduced annualized expenses by
$3.1 million (26% decrease) - Q2 operating expenses down to
$2.2 million from$3.0 million year-over-year - Cash and cash equivalents of
$6.4 million as of June 30, 2024
While these measures improve ENDRA's short-term financial stability, the company's focus on clinical and regulatory activities suggests continued cash burn. Investors should monitor the burn rate and potential need for future capital raises.
ENDRA's progress in clinical and regulatory activities for its TAEUS technology is promising. Key developments include:
- Meeting with the FDA to demonstrate TAEUS and review clinical plans
- Initiation of new pilot clinical trials in North America and Europe
- Expansion of intellectual property portfolio to 81 issued patents globally
The appointment of Ziad Rouag as Head of Regulatory and Clinical Affairs strengthens ENDRA's expertise in this important area. However, the timeline for FDA approval remains uncertain. The company's shift from development to clinical activities and product optimization indicates a maturing product pipeline, but investors should be aware that regulatory processes can be lengthy and unpredictable.
ENDRA's recent leadership changes and strategic shift signal a pivotal moment for the company. The appointment of Alexander Tokman as acting CEO, along with new executives in finance and regulatory affairs, brings valuable experience to guide ENDRA through its next phase. The company's focus on:
- Securing clinical data for FDA submission
- Revisiting go-to-market strategy
- Prioritizing promising vertical markets
indicates a more targeted approach to commercialization. However, the success of TAEUS in the market remains to be seen. Investors should watch for updates on clinical trial results and any partnerships or licensing deals that could validate the technology's market potential.
Conference call begins at 4:30 p.m. Eastern time today
New executive team
- Subsequent to quarter-end, ENDRA announced leadership changes. Board member Alexander Tokman was appointed as acting CEO, bringing 24+ years of global commercial leadership experience. Additionally, two industry veterans joined in key roles including regulatory and clinical affairs, and finance. Richard Jacroux, new Chief Financial Officer, has over 20 years of experience in financial management and accounting and has held the role of CFO at several technology companies. Ziad Rouag, Head of Regulatory and Clinical Affairs, brings to ENDRA more than two decades of experience in the medical device industry as a leader of clinical operations and regulatory affairs for emerging startups and high-growth businesses.
Focus on clinical and regulatory activities
-
Advanced the
U.S. regulatory process. ENDRA met with theU.S. Food and Drug Administration (FDA) at their headquarters inMaryland to demonstrate the TAEUS technology and review the clinical and statistical plans. The meeting minutes confirmed alignment on the topics discussed and the steps required for a successful regulatory outcome. To drive the process forward, ENDRA has hired Mr. Rouag, an experienced regulatory and clinical leader. -
Started new pilot clinical trials. New pilot trials were initiated at two clinical sites in
North America and one is expected to commence inEurope to generate data that support TAEUS' value to clinical users. ENDRA will use the data from these sites to demonstrate the TAEUS system’s performance to the FDA before initiating the De Novo pivotal study. -
Expanded the intellectual property portfolio, now with 81 issued patents globally. During the second quarter of 2024, ENDRA was issued five additional patents, including three in
Europe and two inChina . ENDRA’s broad intellectual property portfolio provides protection for the TAEUS system with its novel thermoacoustic technology and the opportunity to explore licensing opportunities for indications beyond its core focus.
Raised capital and significantly reduced operating expenses
-
Raised
in a public offering. The company raised approximately$8.0 million in gross proceeds from the sale of common stock and warrants in a public offering.$8.0 million -
Significantly reduced operating expenses. As part of focusing resources on clinical and regulatory activities, ENDRA restructured operations, reducing annualized expenses by
compared with the prior-year second quarter.$3.1 million
“In the near-term, the company is prioritizing securing the clinical data to support a new De Novo regulatory filing with the FDA above all other goals,” said Alexander Tokman, acting Chief Executive Officer. “In parallel, we are revisiting our go-to-market strategy for TAEUS to ensure we are prioritizing the most promising vertical markets while formalizing our longer-term business strategy and crystalizing our vision for ENDRA. All of this is being done with careful attention to operating expenses, which we recently reduced by
Second Quarter 2024 Financial Results
Operating expenses in the second quarter of 2024 were
Cash and cash equivalents were
Conference Call and Webcast
Management will host a conference call and webcast beginning at 4:30 p.m. Eastern time today, to discuss these results, provide an update on recent corporate developments and answer questions.
Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the start of the call. Those unable to pre-register may participate by dialing (844) 868-8846 (
A telephone replay will be available until August 29, 2024 by dialing (877) 344-7529 (
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology that characterizes tissue similar to an MRI, but at 1/40th the cost and at the point of patient care. TAEUS® is initially focused on the non-invasive assessment of fatty tissue in the liver. Steatotic liver disease (SLD, formerly known as NAFLD-NASH) is a chronic liver disease spectrum that affects over two billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including non-invasive visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.
Forward-Looking Statements
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of terms such as “approximate,” "anticipate," “attempt,” "believe," "could," "estimate," "expect," “forecast,” “future,” "goal," “hope,” "intend," "may," "plan," “possible,” “potential,” “project,” "seek," "should," "will," “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Examples of forward-looking statements for ENDRA include, among others: expectations with respect to FDA requirements regarding its clinical trials and de novo submission for its TAEUS liver device; estimates of the timing of future events and anticipated results of its development efforts, including the timing of submission for and receipt of required regulatory approvals and product launches and sales; statements relating to future financial position and projected costs and revenue; expectations concerning ENDRA's business strategy; and statements regarding ENDRA’s ability to find and maintain development partners. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others: the ability to raise additional capital in order to continue as a going concern; the ability to obtain FDA and other regulatory approvals necessary to sell ENDRA medical devices in certain markets in a timely manner, or at all; the ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; ENDRA’s ability to regain compliance with Nasdaq listing standards and remain listed on a securities exchange; ENDRA’s dependence on its senior management team; market acceptance of ENDRA’s technology and the amount and nature of competition in its industry; ENDRA’s ability to protect its intellectual property; and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recent Annual Report on Form 10-K and in subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
[Financial Tables Follow]
ENDRA Life Sciences Inc. Condensed Consolidated Balance Sheets |
||||||||
|
|
June 30, |
|
|
December 31, |
|
||
Assets |
|
2024 |
|
|
2023 |
|
||
Current Assets |
|
(Unaudited) |
|
|
|
|
||
Cash |
|
$ |
6,400,732 |
|
|
$ |
2,833,907 |
|
Prepaid expenses |
|
|
312,742 |
|
|
|
198,905 |
|
Total Current Assets |
|
|
6,713,474 |
|
|
|
3,032,812 |
|
Non-Current Assets |
|
|
|
|
|
|
|
|
Inventory |
|
|
2,711,923 |
|
|
|
2,622,865 |
|
Fixed assets, net |
|
|
91,777 |
|
|
|
111,782 |
|
Right of use assets |
|
|
272,284 |
|
|
|
354,091 |
|
Prepaid expenses, long term |
|
|
647,085 |
|
|
|
626,610 |
|
Other assets |
|
|
5,986 |
|
|
|
5,986 |
|
Total Assets |
|
$ |
10,442,529 |
|
|
$ |
6,754,146 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
1,167,434 |
|
|
$ |
700,754 |
|
Lease liabilities, current portion |
|
|
182,733 |
|
|
|
173,857 |
|
Loans |
|
|
- |
|
|
|
28,484 |
|
Total Current Liabilities |
|
|
1,350,167 |
|
|
|
903,095 |
|
|
|
|
|
|
|
|
|
|
Long Term Debt |
|
|
|
|
|
|
|
|
Lease liabilities |
|
|
98,421 |
|
|
|
192,062 |
|
Total Long Term Debt |
|
|
98,421 |
|
|
|
192,062 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
1,448,588 |
|
|
|
1,095,157 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Series A Convertible Preferred Stock, |
|
|
- |
|
|
|
1 |
|
Series B Convertible Preferred Stock, |
|
|
- |
|
|
|
- |
|
Series C Convertible Preferred Stock, |
|
|
- |
|
|
|
- |
|
Common stock, |
|
|
7,244 |
|
|
|
1,039 |
|
Additional paid in capital |
|
|
105,921,675 |
|
|
|
97,582,868 |
|
Stock payable |
|
|
27 |
|
|
|
5,233 |
|
Accumulated deficit |
|
|
(96,935,005 |
) |
|
|
(91,930,152 |
) |
Total Stockholders’ Equity |
|
|
8,993,941 |
|
|
|
5,658,989 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
10,442,529 |
|
|
$ |
6,754,146 |
|
ENDRA Life Sciences Inc. Condensed Consolidated Statements of Operations (Unaudited) |
||||||||||||||||
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
Six Months Ended |
|
||||
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
716,366 |
|
|
$ |
1,400,182 |
|
|
$ |
1,757,892 |
|
|
$ |
2,791,496 |
|
Sales and marketing |
|
|
162,952 |
|
|
|
247,773 |
|
|
|
401,612 |
|
|
|
429,389 |
|
General and administrative |
|
|
1,351,535 |
|
|
|
1,346,610 |
|
|
|
2,851,890 |
|
|
|
2,713,008 |
|
Total operating expenses |
|
|
2,230,853 |
|
|
|
2,994,565 |
|
|
|
5,011,394 |
|
|
|
5,933,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(2,230,853 |
) |
|
|
(2,994,565 |
) |
|
|
(5,011,394 |
) |
|
|
(5,933,893 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
1,700 |
|
|
|
437,433 |
|
|
|
6,541 |
|
|
|
434,015 |
|
Total other income |
|
|
1,700 |
|
|
|
437,433 |
|
|
|
6,541 |
|
|
|
434,015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations before income taxes |
|
|
(2,229,153 |
) |
|
|
(2,557,132 |
) |
|
|
(5,004,853 |
) |
|
|
(5,499,878 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(2,229,153 |
) |
|
$ |
(2,557,132 |
) |
|
$ |
(5,004,853 |
) |
|
$ |
(5,499,878 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share – basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.26 |
) |
|
$ |
(1.20 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares – basic and diluted |
|
|
27,283,009 |
|
|
|
5,996,186 |
|
|
|
18,998,902 |
|
|
|
4,582,645 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240822003939/en/
Company:
Richard Jacroux
Chief Financial Officer
investors@endrainc.com
www.endrainc.com
Investor Relations:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
Source: ENDRA Life Sciences Inc.
FAQ
What were ENDRA Life Sciences' (NDRA) key financial results for Q2 2024?
How much did ENDRA Life Sciences (NDRA) reduce its operating expenses in Q2 2024?
What is ENDRA Life Sciences' (NDRA) current focus for its TAEUS technology?