Elevation Oncology Reports Third Quarter 2024 Financial Results and Highlights Recent Business Achievements
Elevation Oncology (ELEV) reported Q3 2024 financial results and progress on EO-3021, their Claudin 18.2 antibody-drug conjugate. Key highlights include a 42.8% confirmed objective response rate in Claudin 18.2-enriched gastric and GEJ cancer patients, with a favorable safety profile. The company received FDA Fast Track designation for EO-3021 and progressed to the dose expansion phase, with additional data expected in 1H 2025.
Financial results show cash position of $103.1 million, Q3 net loss of $12.9 million, and funding runway into 2026. R&D expenses increased to $9.4 million from $7.4 million year-over-year, while G&A expenses rose to $3.8 million from $3.5 million.
Elevation Oncology (ELEV) ha riportato i risultati finanziari del terzo trimestre del 2024 e i progressi su EO-3021, il loro coniugato di anticorpo-farmacologico per Claudin 18.2. Tra i punti salienti si evidenzia un tasso di risposta obiettiva confermata del 42,8% nei pazienti con cancro gastrico e GEJ arricchiti di Claudin 18.2, con un profilo di sicurezza favorevole. L'azienda ha ricevuto la designazione Fast Track dalla FDA per EO-3021 ed è passata alla fase di espansione della dose, con dati aggiuntivi attesi nel primo semestre del 2025.
I risultati finanziari mostrano una posizione di cassa di 103,1 milioni di dollari, una perdita netta nel terzo trimestre di 12,9 milioni di dollari, e una liquidità che si estende fino al 2026. Le spese per R&S sono aumentate a 9,4 milioni di dollari, rispetto ai 7,4 milioni dell'anno precedente, mentre le spese generali e amministrative sono salite a 3,8 milioni di dollari, rispetto ai 3,5 milioni.
Elevation Oncology (ELEV) informó sobre los resultados financieros del tercer trimestre de 2024 y los avances en EO-3021, su conjugado de anticuerpo-fármaco para Claudin 18.2. Los aspectos destacados incluyen una tasa de respuesta objetiva confirmada del 42.8% en pacientes con cáncer gástrico y de GEJ enriquecidos con Claudin 18.2, con un perfil de seguridad favorable. La compañía recibió la designación Fast Track de la FDA para EO-3021 y avanzó a la fase de expansión de dosis, con datos adicionales que se esperan en la primera mitad de 2025.
Los resultados financieros muestran una posición de efectivo de 103.1 millones de dólares, una pérdida neta en el tercer trimestre de 12.9 millones de dólares, y una financiación que se extiende hasta 2026. Los gastos de I+D aumentaron a 9.4 millones de dólares, en comparación con 7.4 millones del año anterior, mientras que los gastos generales y administrativos crecieron a 3.8 millones de dólares, en comparación con 3.5 millones.
Elevation Oncology (ELEV)가 2024년 3분기 재무 결과와 Claudin 18.2 항체-약물 결합체인 EO-3021의 진행 상황을 보고했습니다. 주요 하이라이트로는 Claudin 18.2가 풍부한 위 및 GEJ 암 환자에서 42.8%의 확인된 객관적 반응률과 우호적인 안전성 프로파일을 포함합니다. 회사는 EO-3021에 대해 FDA의 신속 승인 지정을 받았으며, 용량 확장 단계로 나아갔고, 추가 데이터는 2025년 상반기에 예정되어 있습니다.
재무 결과에 따르면 현금 보유액은 1억 310만 달러, 3분기 순손실은 1천 290만 달러이며, 2026년까지 자금이 확보되어 있습니다. R&D 비용은 전년 대비 740만 달러에서 940만 달러로 증가하였고, 관리비용은 350만 달러에서 380만 달러로 증가했습니다.
Elevation Oncology (ELEV) a rapporté les résultats financiers du troisième trimestre 2024 et les avancées concernant EO-3021, son conjugué anticorps-médicament pour Claudin 18.2. Parmi les points saillants, on note un taux de réponse objective confirmé de 42,8 % chez les patients atteints de cancer gastrique et GEJ enrichis en Claudin 18.2, avec un profil de sécurité favorable. La société a reçu la désignation Fast Track de la FDA pour EO-3021 et est passée à la phase d'expansion de la dose, avec des données supplémentaires attendues au premier semestre 2025.
Les résultats financiers montrent une position de trésorerie de 103,1 millions de dollars, une perte nette de 12,9 millions de dollars au troisième trimestre et une durée de financement s'étendant jusqu'en 2026. Les dépenses de R&D ont augmenté à 9,4 millions de dollars contre 7,4 millions l'année précédente, tandis que les dépenses générales et administratives sont passées de 3,5 millions à 3,8 millions de dollars.
Elevation Oncology (ELEV) hat die finanziellen Ergebnisse des dritten Quartals 2024 und Fortschritte bei EO-3021, ihrem Antikörper-Wirkstoff-Konjugat für Claudin 18.2, berichtet. Zu den wichtigsten Punkten zählt eine bestätigte objektive Ansprechrate von 42,8% bei mit Claudin 18.2 angereicherten Patienten mit Magen- und GEJ-Krebs, mit einem günstigen Sicherheitsprofil. Das Unternehmen erhielt die Fast Track-Zulassung der FDA für EO-3021 und ist in die Phase der Dosiserweiterung eingetreten, wobei weitere Daten in der ersten Hälfte von 2025 erwartet werden.
Die finanziellen Ergebnisse zeigen eine Bargeldposition von 103,1 Millionen US-Dollar, einen Nettoverlust im 3. Quartal von 12,9 Millionen US-Dollar und eine Finanzierung, die bis 2026 reicht. Die F&E-Ausgaben stiegen von 7,4 Millionen auf 9,4 Millionen US-Dollar im Jahresvergleich, während die allgemeinen und Verwaltungskosten von 3,5 Millionen auf 3,8 Millionen US-Dollar stiegen.
- 42.8% confirmed objective response rate in Claudin 18.2-enriched cancer patients
- FDA Fast Track designation received for EO-3021
- Strong cash position of $103.1 million, sufficient to fund operations into 2026
- 71.4% disease control rate in target patient group
- Increased net loss to $12.9 million from $10.6 million year-over-year
- Higher R&D expenses at $9.4 million, up from $7.4 million
- Increased G&A expenses to $3.8 million from $3.5 million
Insights
The Q3 results show mixed signals. While
The promising Phase 1 data for EO-3021 with
The initial clinical data for EO-3021 shows strong potential in gastric/GEJ cancers. The
The strategy to pursue combinations with ramucirumab (VEGFR2) and dostarlimab (PD-1) in both first and second-line settings is scientifically sound. The favorable safety profile could enable these combinations where other Claudin 18.2 ADCs may struggle. The Fast Track designation validates the unmet need and development approach.
-- Promising initial Phase 1 data of EO-3021 reported in August highlighting
-- Progressed into dose expansion portion of Phase 1 trial; additional monotherapy data expected in 1H 2025 --
-- Expect to present preclinical data on the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at ESMO Immuno-Oncology Annual Congress 2024 (ESMO-IO 2024) --
-- Expect to initiate dosing in combination portion of the Phase 1 trial of EO-3021 in 4Q 2024 --
-- On-track to nominate development candidate for HER3-ADC program in 4Q 2024 --
"We continue to make significant progress with EO-3021, our potentially best-in-class Claudin 18.2 antibody-drug conjugate (ADC). Based on the favorable initial clinical data reported in August, we are advancing EO-3021 in both the monotherapy and combination settings across early and later lines of therapy for patients with Claudin 18.2-expressing gastric or GEJ cancer," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "In the past quarter, we initiated the dose expansion portion of the Phase 1 trial of monotherapy EO-3021 and we look forward to reporting additional data in the first half of 2025."
Mr. Ferra continued, "We are encouraged by the promising preliminary efficacy and differentiated safety profile seen in the dose escalation portion of our Phase 1 trial. The favorable initial data highlights EO-3021's unique potential as a more combinable Claudin 18.2 ADC with competitive anti-tumor activity. We are well-positioned to explore the full promise of EO-3021 including its better combinability, and are initiating the combination portion of our Phase 1 trial in Q4 2024. Additionally, we look forward to sharing preclinical data at ESMO-IO 2024 in December that further reinforce our combination strategy with VEGFR2 or PD-1 inhibitors. Together with our ongoing monotherapy efforts, this reflects a robust, broad clinical development plan that will allow us to evaluate EO-3021 across the first, second and later lines of therapy. We remain focused on generating meaningful data and executing toward our goal of bringing important treatment options to patients with significant unmet medical needs."
Recent Business Achievements
- In September 2024, Elevation Oncology announced that the
U.S. Food and Drug Administration (FDA) granted Fast Track designation (FTD) to EO-3021 for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy. Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with FTD may also be eligible for priority review and accelerated approval if supported by clinical data. - In August 2024, Elevation Oncology announced promising initial clinical data from the dose escalation portion of the ongoing Phase 1 clinical trial of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, GEJ, pancreatic or esophageal cancers. As of the data cutoff date of June 10, 2024:
- In seven patients with Claudin 18.2 in ≥
20% of tumor cells at IHC 2+/3+:- Objective response rate (ORR) was
42.8% (three confirmed partial responses, one of which was confirmed following the June 10, 2024 data cutoff). - Disease control rate (DCR) was
71.4% , including two patients with stable disease.
- Objective response rate (ORR) was
- EO-3021 was observed to be generally well-tolerated:
- Minimal hematological toxicity or hepatotoxicity, and no peripheral neuropathy/hypoesthesia was observed in the safety population of 32 patients treated with EO-3021.
- Initial safety data suggests minimal payload-associated toxicity and limited overlapping toxicity with standard-of-care agents including PD-1 inhibitors and chemotherapies.
- In seven patients with Claudin 18.2 in ≥
Expected Upcoming Milestones
EO-3021:
- Present preclinical data on the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at ESMO-IO 2024 in December 2024.
- Initiate dosing in combination portion of the ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter of 2024; combination cohorts will explore EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in the second-line setting and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting.
- Report additional data from the ongoing Phase 1 clinical trial of monotherapy EO-3021, including from the dose expansion cohort, in the first half of 2025.
HER3-ADC:
- Nominate development candidate for HER3-ADC program in the fourth quarter of 2024.
Third Quarter 2024 Financial Results
As of September 30, 2024, Elevation Oncology had cash, cash equivalents and marketable securities totaling
Research and development (R&D) expenses for the third quarter of 2024 were
General and administrative (G&A) expenses for the third quarter of 2024 were
Net loss for the third quarter of 2024 was
Financial Outlook
Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of September 30, 2024 to be sufficient to fund its current operations into 2026.
About EO-3021
EO-3021 is a differentiated, clinical-stage, potentially best-in-class, antibody-drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with a cleavable linker that is site-specifically conjugated to Glutamine 295 providing a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in the dose expansion portion of a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. Following recently signed clinical supply agreements with Lilly and GSK, respectively, Elevation Oncology will evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in second-line patients and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting.
In September 2024, EO-3021 was granted Fast Track designation by the FDA for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy. EO-3021 was granted orphan drug designation by the FDA for the treatment of gastric cancer (including cancer of gastroesophageal junction) in November 2020 and for the treatment of pancreatic cancer in May 2021.
Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside
About Elevation Oncology, Inc.
Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our ADC expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class, Claudin 18.2 ADC and is currently being evaluated in the dose expansion portion of a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. For more information, visit www.ElevationOncology.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical and preclinical development activities, expected timing of announcements of clinical and preclinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates, the ability of Elevation Oncology's product candidates to treat their targeted indications and Elevation Oncology's expectations about its cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Elevation Oncology Investor and Media Contact
Gracie Tong
Senior Director, Investor Relations and Corporate Communications
gtong@elevationoncology.com
Selected Financial Information | ||||||
(In thousands, except share and per share data) | ||||||
(unaudited) | ||||||
Three months ended September 30, | ||||||
2024 | 2023 | |||||
Statement of Operations items: | ||||||
Operating expenses: | ||||||
Research and development | $ | 9,388 | $ | 7,422 | ||
General and administrative | 3,841 | 3,498 | ||||
Total operating expenses | 13,229 | 10,920 | ||||
Loss from operations | (13,229) | (10,920) | ||||
Other income (expense): | ||||||
Interest income (expense), net | 360 | 295 | ||||
Total other income (expense), net | 360 | 295 | ||||
Loss before income taxes | (12,869) | (10,625) | ||||
Income tax expense | 12 | 11 | ||||
Net loss | $ | (12,881) | $ | (10,636) | ||
Net loss per share, basic and diluted | $ | (0.22) | $ | (0.23) | ||
Weighted average common shares outstanding, basic and diluted | 59,108,724 | 46,842,489 | ||||
Selected Financial Information | ||||||
(In thousands, except share and per share data) | ||||||
(unaudited) | ||||||
Selected Balance Sheet items: | September 30, 2024 | December 31, 2023 | ||||
Cash, cash equivalents and marketable securities | $ | 103,070 | $ | 83,107 | ||
Working capital1 | 99,397 | 83,819 | ||||
Total assets | 106,302 | 89,091 | ||||
Long-term debt, net of discount | 31,021 | 30,137 | ||||
Total stockholders' equity | 69,355 | 54,809 | ||||
1. We define working capital as current assets less current liabilities. |
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SOURCE Elevation Oncology
FAQ
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