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Aethlon Medical Announces Financial Results for the Fiscal First Quarter Ended June 30, 2024 and Provides Corporate Update

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Aethlon Medical (AEMD) reported financial results for Q1 FY2025 ended June 30, 2024. Key highlights:

1. Received ethics approvals for Hemopurifier® trial in Australia for solid tumor patients not responding to anti-PD-1 antibodies.

2. Expects to open patient enrollment in October 2024.

3. Achieved 24% reduction in Q1 operating expenses vs. Q1 FY2024.

4. Cash balance of $9.1 million as of June 30, 2024.

5. Net loss decreased to $2.6 million in Q1 FY2025 from $3.3 million in Q1 FY2024.

6. Exploring Hemopurifier use for viral infections.

7. COVID-19 trial in India remains open.

Aethlon Medical (AEMD) ha riportato i risultati finanziari per il primo trimestre dell'anno fiscale 2025, conclusosi il 30 giugno 2024. Punti salienti:

1. Ha ottenuto le approvazioni etiche per il trial del Hemopurifier® in Australia per pazienti con tumori solidi che non rispondono agli anticorpi anti-PD-1.

2. Prevede di aprire le iscrizioni dei pazienti a ottobre 2024.

3. Ha raggiunto una riduzione del 24% delle spese operative nel primo trimestre rispetto al primo trimestre dell'anno fiscale 2024.

4. Saldo di cassa di 9.1 milioni di dollari al 30 giugno 2024.

5. La perdita netta è diminuita a 2.6 milioni di dollari nel primo trimestre dell'anno fiscale 2025 rispetto ai 3.3 milioni di dollari nel primo trimestre dell'anno fiscale 2024.

6. Sta esplorando l'uso del Hemopurifier per le infezioni virali.

7. Il trial COVID-19 in India rimane aperto.

Aethlon Medical (AEMD) reportó los resultados financieros del primer trimestre del año fiscal 2025, que terminó el 30 de junio de 2024. Puntos destacados:

1. Recibió aprobaciones éticas para el ensayo del Hemopurifier® en Australia para pacientes con tumores sólidos que no responden a los anticuerpos anti-PD-1.

2. Se espera abrir la inscripción de pacientes en octubre de 2024.

3. Logró una reducción del 24% en los gastos operativos del primer trimestre en comparación con el primer trimestre del año fiscal 2024.

4. Saldo de efectivo de 9.1 millones de dólares al 30 de junio de 2024.

5. La pérdida neta disminuyó a 2.6 millones de dólares en el primer trimestre del año fiscal 2025 desde 3.3 millones de dólares en el primer trimestre del año fiscal 2024.

6. Está explorando el uso de Hemopurifier para infecciones virales.

7. El ensayo de COVID-19 en India sigue abierto.

Aethlon Medical (AEMD)는 2024년 6월 30일 종료된 FY2025 1분기 재무 결과를 보고했습니다. 주요 사항:

1. PD-1 항체에 반응하지 않는 고형 종양 환자를 위한 Hemopurifier® 시험에 대한 윤리적 승인을 호주에서 받았습니다.

2. 2024년 10월에 환자 모집을 시작할 예정입니다.

3. FY2024 1분기 대비 1분기 운영 비용을 24% 감소시켰습니다.

4. 2024년 6월 30일 기준 현금 잔액은 910만 달러입니다.

5. FY2025 1분기 순손실이 FY2024 1분기 330만 달러에서 260만 달러로 감소했습니다.

6. 바이러스 감염에 대한 Hemopurifier의 사용을 탐색하고 있습니다.

7. 인도의 COVID-19 시험은 계속 열려 있습니다.

Aethlon Medical (AEMD) a rapporté les résultats financiers pour le premier trimestre de l'exercice 2025, se terminant le 30 juin 2024. Points clés:

1. A reçu des approbations éthiques pour l'essai du Hemopurifier® en Australie pour les patients atteints de tumeurs solides qui ne répondent pas aux anticorps anti-PD-1.

2. Prévoit d'ouvrir les inscriptions des patients en octobre 2024.

3. A réalisé une réduction de 24 % des dépenses opérationnelles au premier trimestre par rapport au premier trimestre de l'exercice 2024.

4. Solde de trésorerie de 9,1 millions de dollars au 30 juin 2024.

5. La perte nette a diminué à 2,6 millions de dollars au premier trimestre de l'exercice 2025 contre 3,3 millions de dollars au premier trimestre de l'exercice 2024.

6. Explore l'utilisation du Hemopurifier pour les infections virales.

7. L'essai COVID-19 en Inde reste ouvert.

Aethlon Medical (AEMD) berichtete über die finanziellen Ergebnisse für das 1. Quartal des Geschäftsjahres 2025, das am 30. Juni 2024 endete. Wichtige Punkte:

1. Ethikgenehmigungen für die Hemopurifier®-Studie in Australien für Patienten mit soliden Tumoren, die nicht auf Anti-PD-1-Antikörper ansprechen, wurden erhalten.

2. Die Patientenregistrierung wird für Oktober 2024 erwartet.

3. Im Vergleich zum 1. Quartal des Geschäftsjahres 2024 wurde eine Reduzierung der Betriebskosten um 24 % erreicht.

4. Der Bargeldbestand beträgt 9,1 Millionen Dollar zum 30. Juni 2024.

5. Der Nettoverlust verringerte sich im 1. Quartal des Geschäftsjahres 2025 auf 2,6 Millionen Dollar von 3,3 Millionen Dollar im 1. Quartal des Geschäftsjahres 2024.

6. Es wird die Verwendung des Hemopurifiers bei Virusinfektionen geprüft.

7. Die COVID-19-Studie in Indien bleibt offen.

Positive
  • Received ethics approvals for Hemopurifier trial in Australia
  • 24% reduction in Q1 operating expenses compared to previous year
  • Net loss decreased from $3.3 million to $2.6 million year-over-year
  • Maintained strong cash position of $9.1 million
Negative
  • Still incurring net losses ($2.6 million in Q1)
  • COVID-19 trial in India has only treated one patient so far

Insights

Aethlon Medical's Q1 FY2024 results show a significant 24% reduction in operating expenses, dropping from $3.4 million to $2.6 million year-over-year. This cost-cutting is primarily driven by decreases in general and administrative expenses ($600,000) and professional fees ($300,000). The company's cash balance stands at $9.1 million, which is important for funding ongoing clinical trials and operations.

While revenue figures aren't provided, the reduced net loss (from $3.3 million to $2.6 million) is a positive sign. However, investors should note that Aethlon is still in the research and development phase, with no commercial products generating revenue. The company's financial health will heavily depend on the success of its Hemopurifier® trials and potential future partnerships or funding rounds.

Aethlon's Hemopurifier® is entering a critical phase with the approval of two Australian ethics committees for a safety, feasibility and dose-finding study in cancer patients. This trial targets a significant unmet need, as only 30% of patients respond to anti-PD-1 therapies like Keytruda® or Opdivo®. The Hemopurifier's potential to remove tumor-produced extracellular vesicles (EVs) could enhance the efficacy of these treatments.

The trial's design, focusing on safety and EV concentration changes, is prudent for this stage. If successful, it could pave the way for larger efficacy studies and potential FDA approval. However, investors should be aware that the road to market is long and success in early-stage trials doesn't guarantee final approval or commercial viability.

Received Two Australian Ethics Committee Approvals for a Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies; Expects to Open Patient Enrollment in October of 2024

Achieved Significant 24% Reduction in Fiscal First Quarter Operating Expenses Compared to the Same Period in 2023

Conference Call to be Held Today at 4:30 p.m. ET

SAN DIEGO, Aug. 14, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal first quarter ended June 30, 2024 and provided an update on recent developments.

Company Updates

Aethlon Medical is continuing the research and clinical development of its Hemopurifier®, a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids. These qualities of the Hemopurifier have potential applications in oncology, where cancer associated exosomes may promote immune suppression and metastasis, in life-threatening infectious diseases, and in organ transplantation.

As announced on August 12, 2024, the Bellberry Human Research Ethics Committee (BHREC) granted full ethics approval to the Pindara Private Hospital for a safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck's Keytruda® (pembrolizumab) or Bristol Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for one year, until August 6, 2025. The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital, located in Queensland, Australia.

Earlier, on June 18, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for the same safety, feasibility and dose-finding clinical trial of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for three years, until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.

Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.

"During the fiscal first quarter and subsequent period, we have continued to make significant progress advancing towards our planned oncology trials in Australia and India, punctuated by the recent approval from the Bellberry Human Research Ethics Committee (BHREC), which granted full ethics approval to the Pindara Private Hospital and earlier from the Human Research Ethics Committee at Central Adelaide Local Health Network, in June, for a safety, feasibility and dose-finding clinical trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment," stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical."

"Going forward, the next steps are to receive approval from the Research Governance Office at each hospital, which reviews indemnities and insurance. Once these approvals are obtained, Aethlon, in concert with our Australian Contract Research Organization, ReSQ, will conduct Site Initiation Visits (SIVs), after which patient enrollment in the trials may proceed. We expect that we will be open for enrollment in October 2024."

Mr. Frakes continued, "We anticipate several upcoming, potential value-creating milestones, including submission to the Ethics Committees at a third site in Australia and one in site in India, with the expectation of possibly receiving approval from one or both of those hospitals in the September or December quarter of 2024.  After approval is granted, we expect to be able to enroll patients at those additional sites by the end of 2024."

As a reminder, the primary endpoint of the approximate 9 to 18-patient, safety, feasibility and dose-finding trial, is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of subsequent efficacy and safety trials, including a Premarket Approval (PMA) study required by the FDA and other regulatory agencies.

The company continues to explore opportunities to expand the use of the Hemopurifier as a treatment for life-threatening viral infections. In vitro, it has shown effectiveness in capturing viruses such as Zika, Lassa, MERS-CoV, cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, smallpox-related viruses, H1N1 swine flu, H5N1 bird flu, Monkeypox, and the reconstructed 1918 Spanish flu virus. The company's COVID-19 trial in India remains open to accommodate any potential COVID-19 admissions to the intensive care units at the two participating sites, Medanta Medicity Hospital and Maulana Azad Medical College. So far, one patient has been treated. The company is actively evaluating COVID-19 admissions and potential enrollment against the ongoing costs of maintaining the trial.

Financial Results for the Fiscal First Quarter Ended June 30, 2024

As of June 30, 2024, Aethlon Medical had a cash balance of approximately $9.1 million.

Consolidated operating expenses for the fiscal quarter ended June 30, 2024 were approximately $2.6 million compared to $3.4 million for the fiscal quarter ended June 30, 2023. This decrease of approximately $800,000, or approximately 24%, in the 2024 period was due to a decrease of approximately $600,000 in general and administrative expenses and a decrease of approximately $300,000 in professional fees partially offset by an increase in payroll and related expenses of approximately $100,000.

The $600,000 decrease in general and administrative expenses in the fiscal quarter ended June 30, 2024 was primarily due to a $447,000 decrease in supplies related to the purchase of raw materials for manufacturing of the Hemopurifier and for lab supplies.

The approximate $300,000 decrease in professional fees was primarily due to a $136,000 decrease in consulting expenses primarily related to termination of services with a contract manufacturing organization, a $110,000 decrease in scientific consulting, and a $78,000 decrease in legal fees relating to general corporate matters.  

The approximate $100,000 increase in payroll and related was primarily due to an increase in separation expenses of approximately $300,000 related to the termination of an employee. That increase was offset by a decrease of $111,000 in stock-based compensation and an $89,000 decrease in general and administration personnel expense.

As a result of the factors noted above, the company's net loss decreased to approximately $2.6 million in the fiscal quarter ended June 30, 2024 from approximately $3.3 million in the fiscal quarter ended June 30, 2023.

The consolidated balance sheet for June 30, 2024, and the consolidated statements of operations for the fiscal quarters ended June 30, 2024 and 2023 follow at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, August 14, 2024, at 4:30 p.m. ET to review the company's financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to https://dpregister.com/sreg/10191735/fd44630e3d . Please note that registered participants will receive their dial-in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741

PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through September 14, 2024. The replay can be accessed via Aethlon Medical's website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 3788019.

About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

Additional information can be found at www.AethlonMedical.com.

Forward-Looking Statements
This press release contains 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 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to raise additional capital on terms favorable to the Company, or at all; the Company's ability to successfully complete development of the Hemopurifier; the Company's ability to successfully demonstrate the utility and safety of the Hemopurifier in cancer and infectious diseases and in the transplant setting; the Company's ability to achieve and realize the anticipated benefits from potential milestones; the Company's ability to submit applications to, and obtain approval from, the additional Ethics Committees in Australia and India, including on the timeline expected by the Company; the Company's ability to initiate its planned oncology clinical trials in Australia and India, including on the timeline expected by the Company; the Company's ability to obtain approvals from Research Governance Offices at relevant hospitals and complete site initiation visits in a timely manner; the Company's ability to manage and successfully complete its clinical trials, if initiated; the Company's ability to successfully manufacture the Hemopurifier in sufficient quantities for its clinical trials; unforeseen changes in regulatory requirements; the Company's ability to maintain its Nasdaq listing; and other potential risks. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2024, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Company Contact:
Jim Frakes
Interim Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
917-513-5303

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

Condensed Consolidated Balance Sheets















ASSETS











June 30, 2024


March 31, 2024


CURRENT ASSETS







Cash and cash equivalents


$                        9,072,379


$                                  5,441,978



Deferred offering costs


-


277,827



Prepaid expenses


478,058


505,983









TOTAL CURRENT ASSETS


9,550,437


6,225,788










Property and equipment, net


929,306


1,015,229



Right-of-use lease asset


813,900


883,054



Patents, net


963


1,100



Restricted cash


87,506


87,506



Deposits


33,305


33,305










TOTAL ASSETS


$                11,415,417


$                         8,245,982
















LIABILITIES AND STOCKHOLDERS' EQUITY








CURRENT LIABILITIES







Accounts payable 


$                        1,068,135


$                                      777,862



Due to related parties


732,518


546,434



Lease liability, current portion


296,093


290,565



Other current liabilities


32,203


215,038









TOTAL CURRENT LIABILITIES


2,128,949


1,829,899










Lease liability, less current portion


573,852


649,751









TOTAL LIABILITIES


2,702,801


2,479,650









COMMITMENTS AND CONTINGENCIES













EQUITY














Common stock, par value of $0.001, 60,000,000 shares







  authorized; 13,937,227 and  2,629,725 issued and outstanding


13,937


2,629



Additional-paid in capital


165,844,620


160,337,371



Accumulated other comprehensive loss


(7,773)


(6,940)



Accumulated deficit


(157,138,168)


(154,566,728)









TOTAL STOCKHOLDERS' EQUITY 


8,712,616


5,766,332










TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY


$                11,415,417


$                         8,245,982


 

AETHLON MEDICAL, INC. AND SUBSIDIARY

 Consolidated Statements of Operations

For the three month periods ended June 30, 2024 and 2023


















Fiscal Year


Fiscal Year



Ended 6/30/24


Ended 6/30/23






OPERATING COSTS AND EXPENSES





Professional fees


614,082


976,638

Payroll and related


1,254,802


1,123,239

General and administrative


751,974


1,308,283

    Total operating expenses


2,620,858


3,408,160






OPERATING LOSS


(2,620,858)


(3,408,160)






OTHER EXPENSE (INCOME)





  Interest Income


49,418


125,981






NET LOSS 


$(2,571,440)


$(3,282,179)






OTHER COMPREHENSIVE LOSS


(833)


(994)






COMPREHENSIVE LOSS


$(2,572,273)


$(3,283,173)






Basic and diluted net loss available to 





  common stockholders per share


$         (0.34)


$         (1.35)






Basic and diluted weighted average number of 





  common shares outstanding 


7,457,888


2,431,476

 

Cision View original content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-financial-results-for-the-fiscal-first-quarter-ended-june-30-2024-and-provides-corporate-update-302221447.html

SOURCE Aethlon Medical, Inc.

FAQ

When does Aethlon Medical expect to start patient enrollment for the Hemopurifier trial in Australia?

Aethlon Medical expects to open patient enrollment for the Hemopurifier trial in Australia in October 2024.

What was Aethlon Medical's (AEMD) cash balance as of June 30, 2024?

Aethlon Medical (AEMD) reported a cash balance of approximately $9.1 million as of June 30, 2024.

How much did Aethlon Medical's (AEMD) operating expenses decrease in Q1 FY2025 compared to Q1 FY2024?

Aethlon Medical's (AEMD) operating expenses decreased by approximately 24% in Q1 FY2025 compared to Q1 FY2024.

What is the primary endpoint of Aethlon Medical's (AEMD) planned Hemopurifier trial in Australia?

The primary endpoint of Aethlon Medical's (AEMD) planned Hemopurifier trial in Australia is safety.

AETHLON MEDICAL INC

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