Elevation Oncology Reports Third Quarter 2024 Financial Results and Highlights Recent Business Achievements
-- Promising initial Phase 1 data of EO-3021 reported in August highlighting 42.8% confirmed ORR observed in Claudin 18.2-enriched subset of gastric and GEJ cancer, with differentiated safety profile --
-- 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 --
BOSTON, Nov. 6, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), 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, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent business achievements.
"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.
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.
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 $103.1 million, compared to $83.1 million as of December 31, 2023. The increase in cash reflects net proceeds of $44.2 million, which Elevation Oncology raised through its at-the-market (ATM) facility in the first half of 2024, partially offset by cash used to fund operating activities.
Research and development (R&D) expenses for the third quarter of 2024 were $9.4 million, compared to $7.4 million for the third quarter of 2023. The increase in R&D expenses was driven by continuous investment in the Company's lead and pipeline programs.
General and administrative (G&A) expenses for the third quarter ...
