Aethlon Medical Announces Financial Results for the Fiscal Second Quarter Ended September 30, 2024 and Provides Corporate Update
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.
- 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
- 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
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
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
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
Company Updates
During the second quarter, and subsequently, the company advanced its oncology trial efforts in
Clinical Trials: The first two patients have now been enrolled at the Royal Adelaide Hospital in
In September, Aethlon received ethics committee approval from Medanta Medicity Hospital in Gurugram,
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
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
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
Financial Results for the Fiscal Second Quarter Ended September 30, 2024
As of September 30, 2024, Aethlon Medical had a cash balance of approximately
Consolidated operating expenses for the fiscal quarter ended September 30, 2024 were approximately
The approximate
The approximate
The
As a result of the factors noted above, the company's net loss decreased to approximately
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
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
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
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 | |||||
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 | |||||
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 | ||||||||
OTHER COMPREHENSIVE INCOME/(LOSS) | 3,804 | (2,435) | 2,971 | (3,429) | ||||
COMPREHENSIVE LOSS | ||||||||
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 | ||||
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SOURCE Aethlon Medical, Inc.
FAQ
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