CEL-SCI Reports Fiscal Q1 2025 Financial Results: Multikine Shows Pre-Surgical Tumor Elimination and Regression in Just 3 Weeks
CEL-SCI (CVM) reported Q1 2025 financial results and key developments. The FDA concurred with CEL-SCI's plan to use PD-L1 as a biomarker for a Phase 3 confirmatory trial of Multikine in head and neck cancer. Previous Phase 3 data showed patients with low PD-L1 expression had 73% 5-year survival vs 45% in control group (p=0.0015). Multikine demonstrated pre-surgical tumor regression in just 3 weeks.
Financial highlights: R&D expenses were $4.4 million, G&A expenses increased to $2.5 million from $2.1 million YoY. Net loss was $7.1 million vs $6.7 million in prior year. Net loss per share improved to $0.11 from $0.14. Cash spent during Q1 was $5.1 million.
CEL-SCI (CVM) ha riportato i risultati finanziari del primo trimestre 2025 e i principali sviluppi. La FDA ha concordato con il piano di CEL-SCI di utilizzare il PD-L1 come biomarker per uno studio clinico di conferma di Fase 3 di Multikine nel cancro testa-collo. I dati precedenti di Fase 3 hanno mostrato che i pazienti con bassa espressione di PD-L1 avevano una sopravvivenza a 5 anni del 73% contro il 45% del gruppo di controllo (p=0.0015). Multikine ha dimostrato una regressione tumorale pre-chirurgica in sole 3 settimane.
Risultati finanziari: le spese per R&S sono state di 4,4 milioni di dollari, mentre le spese generali e amministrative sono aumentate a 2,5 milioni di dollari rispetto ai 2,1 milioni dell'anno precedente. La perdita netta è stata di 7,1 milioni di dollari rispetto ai 6,7 milioni dell'anno precedente. La perdita netta per azione è migliorata a 0,11 dollari rispetto a 0,14 dollari. Il denaro speso durante il primo trimestre è stato di 5,1 milioni di dollari.
CEL-SCI (CVM) informó los resultados financieros del primer trimestre de 2025 y los principales desarrollos. La FDA coincidió con el plan de CEL-SCI de utilizar PD-L1 como biomarcador para un ensayo clínico de confirmación de Fase 3 de Multikine en cáncer de cabeza y cuello. Los datos anteriores de Fase 3 mostraron que los pacientes con baja expresión de PD-L1 tenían una tasa de supervivencia a 5 años del 73% frente al 45% del grupo de control (p=0.0015). Multikine demostró regresión tumoral prequirúrgica en solo 3 semanas.
Aspectos financieros: los gastos de I+D fueron de 4,4 millones de dólares, y los gastos generales y administrativos aumentaron a 2,5 millones de dólares desde 2,1 millones del año anterior. La pérdida neta fue de 7,1 millones de dólares frente a 6,7 millones del año anterior. La pérdida neta por acción mejoró a 0,11 dólares desde 0,14 dólares. El efectivo gastado durante el primer trimestre fue de 5,1 millones de dólares.
CEL-SCI (CVM)는 2025년 1분기 재무 결과 및 주요 개발 사항을 보고했습니다. FDA는 CEL-SCI의 Multikine의 두경부암에 대한 3상 확인 시험에 PD-L1을 바이오마커로 사용하겠다는 계획에 동의했습니다. 이전의 3상 데이터에 따르면, PD-L1 발현이 낮은 환자들은 대조군의 45%에 비해 5년 생존율이 73%였습니다 (p=0.0015). Multikine은 단 3주 만에 수술 전 종양 퇴축을 보여주었습니다.
재무 하이라이트: 연구개발(R&D) 비용은 440만 달러였으며, 일반 및 관리(G&A) 비용은 전년 대비 210만 달러에서 250만 달러로 증가했습니다. 순손실은 710만 달러로, 이전 연도의 670만 달러에 비해 증가했습니다. 주당 순손실은 0.14달러에서 0.11달러로 개선되었습니다. 1분기 동안 지출된 현금은 510만 달러였습니다.
CEL-SCI (CVM) a rapporté les résultats financiers du premier trimestre 2025 et les développements clés. La FDA a convenu du plan de CEL-SCI d'utiliser le PD-L1 comme biomarqueur pour un essai de confirmation de phase 3 de Multikine dans le cancer de la tête et du cou. Les données de la phase 3 précédentes ont montré que les patients ayant une faible expression de PD-L1 avaient un taux de survie à 5 ans de 73 % contre 45 % dans le groupe témoin (p=0.0015). Multikine a démontré une régression tumorale pré-chirurgicale en seulement 3 semaines.
Points financiers : les dépenses de R&D se sont élevées à 4,4 millions de dollars, les dépenses générales et administratives ont augmenté à 2,5 millions de dollars contre 2,1 millions de dollars l'année précédente. La perte nette était de 7,1 millions de dollars contre 6,7 millions de dollars l'année précédente. La perte nette par action s'est améliorée à 0,11 dollar contre 0,14 dollar. L'argent dépensé au cours du premier trimestre s'élevait à 5,1 millions de dollars.
CEL-SCI (CVM) hat die finanziellen Ergebnisse für das erste Quartal 2025 und wichtige Entwicklungen berichtet. Die FDA stimmte dem Plan von CEL-SCI zu, PD-L1 als Biomarker für eine Phase-3-Bestätigungsstudie von Multikine bei Kopf-Hals-Krebs zu verwenden. Frühere Phase-3-Daten zeigten, dass Patienten mit niedriger PD-L1-Expression eine 5-Jahres-Überlebensrate von 73% im Vergleich zu 45% in der Kontrollgruppe hatten (p=0.0015). Multikine zeigte innerhalb von nur 3 Wochen eine präoperative Tumorrückbildung.
Finanzielle Höhepunkte: Die F&E-Ausgaben betrugen 4,4 Millionen Dollar, die allgemeinen und administrativen Ausgaben stiegen im Jahresvergleich von 2,1 Millionen Dollar auf 2,5 Millionen Dollar. Der Nettoverlust betrug 7,1 Millionen Dollar im Vergleich zu 6,7 Millionen Dollar im Vorjahr. Der Nettoverlust pro Aktie verbesserte sich von 0,14 Dollar auf 0,11 Dollar. Die im ersten Quartal ausgegebenen Mittel betrugen 5,1 Millionen Dollar.
- FDA agreement on PD-L1 biomarker strategy for Phase 3 confirmatory trial
- Strong Phase 3 data showing 73% vs 45% 5-year survival rate in target population (p=0.0015)
- 21% improvement in net loss per share (0.11 vs 0.14)
- Demonstrated pre-surgical tumor regression in 3 weeks
- Increased net loss of $7.1M vs $6.7M YoY
- Higher G&A expenses of $2.5M vs $2.1M YoY
- Cash burn of $5.1M in Q1
Insights
The latest developments in CEL-SCI's Multikine program represent a significant milestone in head and neck cancer treatment. The FDA's agreement to use PD-L1 as a biomarker is particularly noteworthy, as it positions Multikine to address an underserved market segment. While current checkpoint inhibitors primarily target high PD-L1 expressing tumors, Multikine shows superior efficacy in low PD-L1 patients - estimated at 70% of head and neck cancer cases.
The observed tumor regression within just 3 weeks is remarkable in the immunotherapy landscape, where responses typically take months to manifest. This rapid response, confirmed by pathology at surgery, suggests a powerful immune activation mechanism that could potentially revolutionize the pre-surgical treatment window.
The survival data is compelling - a 28% absolute improvement in 5-year survival rates (73% vs 45%) with a highly significant p-value of 0.0015 in the low PD-L1 population. This represents one of the most substantial survival improvements seen in head and neck cancer trials.
The partnership with Ergomed for the confirmatory Registration Study is strategically important. Their decade-long collaboration and track record in rapid enrollment could accelerate the path to potential approval. The company's projection of efficacy indicators by 2026 appears realistic given the abbreviated 3-week treatment window.
Financially, while the
“CEL-SCI is very uniquely positioned at this moment as an immuno-oncology company with a vast amount of data from the largest Phase 3 head and neck cancer study ever performed, with statistically significant evidence that our drug can successfully fight cancer and extend lives in head and neck cancer,” stated CEL-SCI CEO, Geert Kersten. “We hope to deliver a new standard of care to patients while substantially transforming our company’s valuation to reflect what we believe to be the intrinsic value of our cancer drug. The statistical analysis shows that our very soon to be initiated small confirmatory Registration Study has a very high chance of success and we will have indications of efficacy as early as 2026. Should the pre-surgical tumor responses mirror what we saw in the Phase 3 data, we believe we will be on the path for accelerated and/or conditional approval for Multikine next year.”
Corporate and Clinical Developments include:
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The
U.S. FDA concurred with CEL-SCI’s plan to use of PD-L1 as a biomarker to select patients for a Phase 3 confirmatory trial. The study is designed to confirm the observation in our previous head and neck cancer Phase 3 trial that patients with low PD-L1 expression are most likely to have favorable outcomes from Multikine therapy. These patients, when treated with Multikine in the completed Phase 3 study, had a 5-year survival of73% vs.45% in the control group with a p-value of 0.0015. PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, which appear to work best for patients with high PD-L1 expression. Since Multikine has been shown to be more effective in patients with low PD-L1 expression, Multikine is uniquely positioned to benefit an estimated70% of head and neck patients who have low PD-L1 expression.
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The strong data from our completed Phase 3 study and the biological rationale for the use of Multikine in the treatment of head and neck cancer suggest a high likelihood of success for the confirmatory Registration Study. These data and rationale include:
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Multikine shows pre-surgical tumor regression in head and neck cancer in just 3 weeks - confirmed by pathology at surgery:
- Multikine led to significant rates of tumor regression prior to surgery.
- There was no tumor regression observed in the control group that did not receive Multikine.
- Pre-surgical tumor regressions confirmed at surgery forecast survival benefit.
- The patient population for the Registration Study is likely to show significant survival prolongation.
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Phase 3 Registration Study patient population selection is based on:
- Strong statistical significance with respect to overall survival vs controls in 114 patients in the Phase 3 study.
- Analysis of the patients in this group was pre-defined in the statistical analysis plan (SAP).
- Strong biological rationale for the results seen in these patients based on Multikine’s mechanism of action (MOA) which brings about a strong and sustainable immune response and does not require overcoming PD-L1 blockade.
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Multikine shows pre-surgical tumor regression in head and neck cancer in just 3 weeks - confirmed by pathology at surgery:
- Ergomed, a clinical research organization (CRO) with a strong track record of fast enrollment and high-quality study delivery, is selected as the CRO for CEL-SCI’s confirmatory Registration Study. Ergomed has been a strategic partner and collaborator with CEL-SCI for over 10 years and was instrumental in successfully completing the prior Phase 3 study.
Financial Results
During the three months ended December 31, 2024, research and development expenses were
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor before surgery, radiation and chemotherapy because that is the time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.
The Company has operations in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
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COMPANY CONTACT:
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
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