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

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Aethlon Medical (AEMD) reported fiscal Q2 2024 results and key developments. The company achieved enrollment of first two patients in its Hemopurifier® cancer trial at Royal Adelaide Hospital, Australia. A second site, Pindara Private Hospital, is now open for enrollment. The company received ethics committee approval from Medanta Medicity Hospital in India for a similar trial. Financial highlights include cash balance of $6.9 million and reduced operating expenses to $2.9 million, down 9% year-over-year. Net loss decreased to $2.8 million from $3.0 million in the prior year period. The company implemented cost-cutting measures and appointed James Frakes as permanent CEO.

Aethlon Medical (AEMD) ha riportato i risultati del secondo trimestre fiscale del 2024 e gli sviluppi chiave. L'azienda ha raggiunto l'arruolamento dei primi due pazienti nella sua sperimentazione del Hemopurifier® contro il cancro presso il Royal Adelaide Hospital in Australia. Un secondo sito, il Pindara Private Hospital, è ora aperto per l'arruolamento. L'azienda ha ricevuto l'approvazione del comitato etico dell'ospedale Medanta Medicity in India per un trial simile. Punti salienti finanziari includono un saldo di cassa di 6,9 milioni di dollari e una riduzione delle spese operative a 2,9 milioni di dollari, con una diminuzione del 9% rispetto all'anno precedente. La perdita netta è scesa a 2,8 milioni di dollari rispetto ai 3,0 milioni di dollari del periodo dell'anno precedente. L'azienda ha implementato misure di riduzione dei costi e ha nominato James Frakes come CEO permanente.

Aethlon Medical (AEMD) reportó los resultados del segundo trimestre fiscal de 2024 y desarrollos clave. La compañía logró la inscripción de los primeros dos pacientes en su ensayo clínico del Hemopurifier® contra el cáncer en el Royal Adelaide Hospital, Australia. Un segundo sitio, el Pindara Private Hospital, ya está abierto para inscripciones. La compañía recibió la aprobación del comité de ética del Hospital Medanta Medicity en India para un ensayo similar. Puntos destacados financieros incluyen un saldo de efectivo de 6.9 millones de dólares y gastos operativos reducidos a 2.9 millones de dólares, una disminución del 9% en comparación con el año anterior. La pérdida neta se redujo a 2.8 millones de dólares desde 3.0 millones de dólares en el período del año anterior. La compañía implementó medidas de recorte de costos y nombró a James Frakes como CEO permanente.

Aethlon Medical (AEMD)가 2024 회계 연도 2분기 결과와 주요 개발 사항을 보고했습니다. 이 회사는 호주 로열 아델레이드 병원에서 Hemopurifier® 암 임상 시험에 첫 두 환자의 등록을 완료했습니다. 두 번째 장소인 핀다라 개인 병원도 등록을 위해 열렸습니다. 이 회사는 인도의 메단타 메디시티 병원에서 유사한 임상 시험에 대한 윤리 위원회 승인을 받았습니다. 재무 하이라이트는 690만 달러의 현금 잔액과 운영 비용을 290만 달러로 줄였으며, 이는 작년 대비 9% 감소한 수치입니다. 순 손실은 작년 동기 대비 300만 달러에서 280만 달러로 감소했습니다. 이 회사는 비용 절감 조치를 시행하고 제임스 프레이크스를 상임 CEO로 임명했습니다.

Aethlon Medical (AEMD) a publié les résultats du deuxième trimestre fiscal 2024 et les développements clés. L'entreprise a réussi à inscrire les deux premiers patients dans son essai sur le Hemopurifier® contre le cancer au Royal Adelaide Hospital en Australie. Un deuxième site, le Pindara Private Hospital, est désormais ouvert à l'inscription. L'entreprise a obtenu l'approbation du comité d'éthique de l'hôpital Medanta Medicity en Inde pour un essai similaire. Faits saillants financiers comprennent un solde de trésorerie de 6,9 millions de dollars et des dépenses d'exploitation réduites à 2,9 millions de dollars, soit une baisse de 9 % par rapport à l'année précédente. La perte nette a diminué de 3,0 millions de dollars à 2,8 millions de dollars par rapport à la période de l'année précédente. L'entreprise a mis en œuvre des mesures de réduction des coûts et a nommé James Frakes en tant que PDG permanent.

Aethlon Medical (AEMD) hat die Ergebnisse des fiskalischen zweiten Quartals 2024 und wichtige Entwicklungen bekannt gegeben. Das Unternehmen hat die Einschreibung der ersten beiden Patienten in seine Hemopurifier®-Krebsstudie am Royal Adelaide Hospital in Australien erreicht. Ein zweiter Standort, das Pindara Private Hospital, ist jetzt für die Einschreibung geöffnet. Das Unternehmen erhielt die Genehmigung des Ethikkomitees des Medanta Medicity Hospitals in Indien für eine ähnliche Studie. Finanzielle Höhepunkte umfassen einen Barbestand von 6,9 Millionen Dollar und reduzierte Betriebskosten auf 2,9 Millionen Dollar, was einem Rückgang von 9 % im Vergleich zum Vorjahr entspricht. Der Nettoverlust verringerte sich von 3,0 Millionen Dollar im Vorjahreszeitraum auf 2,8 Millionen Dollar. Das Unternehmen hat Kostensenkungsmaßnahmen umgesetzt und James Frakes als ständigen CEO ernannt.

Positive
  • First two patients enrolled in Hemopurifier® cancer trial
  • Operating expenses reduced by 9% year-over-year
  • Net loss decreased from $3.0M to $2.8M
  • Professional fees decreased by $600,000
  • Two Australian sites now open for patient enrollment
Negative
  • Cash balance of $6.9M may require additional funding
  • $500,000 increase in separation expenses due to workforce reduction
  • Only one patient treated in COVID-19 trial to date

Insights

The Q2 FY2024 results reveal concerning financial metrics for this micro-cap biotech. Cash position of $6.9 million with a quarterly burn rate of approximately $2.8 million suggests roughly 6-7 quarters of runway at current spending levels. While operating expenses decreased by 9% to $2.9 million, this was primarily driven by reduced legal and consulting fees rather than fundamental operational improvements.

The enrollment of two patients in the Hemopurifier cancer trial represents progress, but the path to commercialization remains long and capital-intensive. With a market cap of only $5.7 million, significantly below cash position, the market appears skeptical about the company's ability to reach meaningful clinical milestones before requiring additional financing. The cost-cutting measures, while necessary, may impact the pace of clinical development.

The Hemopurifier's mechanism of targeting extracellular vesicles (EVs) in cancer treatment represents an innovative approach to overcome PD-1 inhibitor resistance, a significant challenge in oncology. Current response rates of only 30% to pembrolizumab or nivolumab highlight the unmet need. The ongoing safety and dose-finding trials in Australia and India are important first steps, but the path to a potential PMA study remains lengthy.

The broad antiviral capabilities demonstrated in vitro are noteworthy, but the minimal progress in COVID-19 trials (only one patient treated) suggests near-term potential in this indication. The focus on oncology applications appears strategically sound but requires substantial clinical validation.

Achieves Key Milestone with Enrollment of First Two Patients in the Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies

Two Australian Sites Open For Patient Enrollment in Hemopurifier® Cancer Trial

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

SAN DIEGO, Nov. 13, 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 second quarter ended September 30, 2024 and provided an update on recent developments.

Company Updates

During the second quarter, and subsequently, the company advanced its oncology trial efforts in Australia, while implementing cost-cutting measures to streamline operations. Management is pleased to report positive progress on these initiatives, specifically:

Clinical Trials: The first two patients have now been enrolled at the Royal Adelaide Hospital in Adelaide, Australia. Additionally, Pindara Private Hospital, in the Gold Coast section of Australia, received ethics committee approval, was trained on Aethlon's Hemopurifier®, and is now open for patient enrollment. The company has also trained a third hospital in Australia, but has not yet received ethics committee approval for that institution and it has not yet begun patient enrollment.

In September, Aethlon received ethics committee approval from Medanta Medicity Hospital in Gurugram, India, for a similar nine to 18-patient, safety, feasibility and dose-finding trial of the Hemopurifier. The company is completing the necessary logistical steps before the site can open for patient enrollment.

Management Change: In October, Aethlon's board of directors appointed James Frakes to serve as the company's permanent Chief Executive Officer, after having served as Interim Chief Executive Officer since November 2023.

Operational Efficiency: Strategic cost-cutting initiatives have allowed for optimized resource allocation, enabling continued focus on high-impact areas of the oncology trial.

"During the second fiscal quarter and subsequent period, we continued advancing our oncology trials, earlier this week announcing enrollment of the first patient at Royal Adelaide Hospital, and now updating this news to report enrollment of a second patient. This represents a critical milestone for the safety, feasibility and dose-finding trials of the Hemopurifier in patients with solid tumors who have failed treatment with anti-PD-1 antibodies," stated James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "We now have two sites open for patient enrollment in Australia, have received ethics committee approval from a site in India, and we expect to continue to enroll subjects in our Hemopurifier cancer trial. As previously announced, we believe these studies will help inform future oncology efficacy trials. Additionally, we have made strategic cost-cutting measures to optimize company resources, in order to focus on the high-impact oncology trials in both Australia and India."

As a reminder, the primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trials, is safety. The trials 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.

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.

The company also 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 Ebola, Marburg virus, Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, 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 Second Quarter Ended September 30, 2024

As of September 30, 2024, Aethlon Medical had a cash balance of approximately $6.9 million.

Consolidated operating expenses for the fiscal quarter ended September 30, 2024 were approximately $2.9 million, compared to $3.2 million for the fiscal quarter ended September 30, 2023. This decrease of approximately $300,000, or 9%, in the 2024 period was due to a decrease of approximately $600,000 in professional fees, partially offset by an increase of approximately $200,000 in payroll and related expenses and an approximately $100,000 increase in general and administrative expenses.

The approximate $600,000 decrease in professional fees was primarily due to a $300,000 reduction in legal fees following a transition to a new legal firm, a $200,000 decrease in contract labor expenses due to project completions with contract manufacturing organizations and research and development consultants, and an $81,000 decrease in accounting fees.

The approximate $200,000 increase in payroll and related expenses was primarily due to an increase of $500,000 in separation expenses related to severance agreements following the termination of an executive and a reduction in workforce. This increase was partially offset by a $200,000 reduction in ongoing payroll expenses and a $100,000 decrease in stock-based compensation as a result of the completion of vesting of existing stock options and reduced headcount.

The $100,000 increase in general and administrative expenses in the fiscal quarter ended September 30, 2024 was primarily due a $200,000 increase in costs associated with the company's ongoing oncology clinical trial. This increase was partially offset by reductions in a number of general and administrative expense items, including decreases in U.S. clinical trial expenses.

As a result of the factors noted above, the company's net loss decreased to approximately $2.8 million in the fiscal quarter ended September 30, 2024, from approximately $3.0 million in the fiscal quarter ended September 30, 2023.

The consolidated balance sheet for September 30, 2024, and the consolidated statements of operations for the three- and six-month periods ended September 30, 2024 and 2023 follow at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, November 13, 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 call by navigating to https://dpregister.com/sreg/10194285/fdebe88214. 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 December 13, 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 10194285.

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 obtain approval from the Ethics Committee of its third location in Australia, including on the timeline expected by the Company; the Company's ability to enroll additional patients in its oncology clinical trials in Australia and India, including on the timeline expected by the Company; the Company's ability to manage and successfully complete its clinical trials; 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
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


AETHLON MEDICAL, INC. AND SUBSIDIARY
Condensed Consolidated Balance Sheets




ASSETS




September 30, 2024


March 31, 2024

CURRENT ASSETS






Cash and cash equivalents


$                       6,859,075


$                                 5,441,978


Deferred offering costs


-


277,827


Prepaid expenses and other current assets


279,008


505,983








TOTAL CURRENT ASSETS


7,138,083


6,225,788








Property and equipment, net


843,617


1,015,229


Operating lease right-of-use  asset


743,994


883,054


Patents, net


825


1,100


Restricted cash


87,506


87,506


Deposits


33,305


33,305








TOTAL ASSETS


$                   8,847,330


$                           8,245,982







LIABILITIES AND STOCKHOLDERS' EQUITY

CURRENT LIABILITIES






Accounts payable


$                          922,888


$                                    777,862


Due to related parties


1,011,544


546,434


Operating lease liability, current portion


301,680


290,565


Accrued Professional Fees


95,338


215,038








TOTAL CURRENT LIABILITIES


2,331,450


1,829,899








Operating lease liability, less current portion


496,772


649,751








TOTAL LIABILITIES


2,828,222


2,479,650







EQUITY












Common stock, par value $0.001 per share; 60,000,000 shares authorized as of
September 30, 2024 and March 31, 2024; 13,961,998 and 2,629,725 shares issued
and outstanding as of September 30, 2024 and March 31, 2024, respectively







13,962


2,629


Additional-paid in capital


165,954,256


160,337,371


Accumulated other comprehensive loss


(3,969)


(6,940)


Accumulated deficit


(159,945,141)


(154,566,728)








TOTAL STOCKHOLDERS' EQUITY


6,019,108


5,766,332








TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY


$                   8,847,330


$                           8,245,982

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

 Consolidated Statements of Operations and Comprehensive Loss

For the three and six month periods ended September 30, 2024 and 2023






























Three Months


Three Months


Six Months


Six Months



Ended 9/30/24


Ended 9/30/23


Ended 9/30/24


Ended 9/30/23










OPERATING COSTS AND EXPENSES









Professional fees


570,845


1,133,111


1,184,927


2,109,749

Payroll and related expenses


1,372,899


1,191,426


2,627,701


2,314,665

General and administrative


958,375


850,809


1,709,228


2,159,092

    Total operating expenses


2,902,119


3,175,346


5,521,856


6,583,506










OPERATING LOSS


(2,902,119)


(3,175,346)


(5,521,856)


(6,583,506)










OTHER INCOME









Interest Income


95,146


140,890


143,442


266,871










NET LOSS


$(2,806,973)


$(3,034,456)


$(5,378,414)


$(6,316,635)










OTHER COMPREHENSIVE INCOME/(LOSS)


3,804


(2,435)


2,971


(3,429)










COMPREHENSIVE LOSS


$(2,803,169)


$(3,036,891)


$(5,375,443)


$(6,320,064)










Basic and diluted loss per share attributable to









  common stockholders


$          (0.20)


$          (1.22)


$          (0.50)


$          (2.57)










Basic and diluted weighted average number of









  common shares outstanding  - basic and diluted


13,937,595


2,483,649


10,715,446


2,457,711










 

Cision View original content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-financial-results-for-the-fiscal-second-quarter-ended-september-30-2024-and-provides-corporate-update-302304742.html

SOURCE Aethlon Medical, Inc.

FAQ

What were Aethlon Medical's (AEMD) Q2 2024 financial results?

Aethlon Medical reported Q2 2024 cash balance of $6.9M, operating expenses of $2.9M (down 9% YoY), and net loss of $2.8M (decreased from $3.0M YoY).

How many patients are enrolled in AEMD's Hemopurifier cancer trial?

Two patients are currently enrolled in the Hemopurifier cancer trial at Royal Adelaide Hospital in Australia.

What is the primary endpoint of AEMD's current cancer trial?

The primary endpoint of the 9-18 patient trial is safety, monitoring adverse events and changes in lab tests of Hemopurifier treated patients with solid tumors.

How much did AEMD reduce its operating expenses in Q2 2024?

AEMD reduced operating expenses by approximately $300,000 or 9%, from $3.2M to $2.9M compared to Q2 2023.

AETHLON MEDICAL INC

NASDAQ:AEMD

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