Elevation Oncology Q3 2024 Financial Results and Business Highlights

Elevation Oncology, Inc., a company specializing in oncology therapies for solid tumors, has announced its third-quarter financial results for 2024, along with notable business achievements. The company has been making significant strides with its leading drug candidate, EO-3021, which targets Claudin 18.2—a protein associated with certain types of cancer, including gastric and gastroesophageal junction (GEJ) cancers.

In August 2024, Elevation Oncology reported encouraging initial data from the Phase 1 trial of EO-3021. The data revealed a 42.8% confirmed objective response rate (ORR) in a subset of gastric and GEJ cancer patients whose tumors were enriched with Claudin 18.2. Additionally, the drug demonstrated a favorable safety profile, which the company believes positions EO-3021 as a potentially best-in-class Claudin 18.2 antibody-drug conjugate (ADC). This progress has led the company to advance EO-3021 into the dose expansion phase of the Phase 1 trial, with further monotherapy data anticipated in the first half of 2025.

EO-3021's development plan also includes exploring its effectiveness in combination with other cancer therapies. The company expects to present preclinical data on combining EO-3021 with VEGFR2 or PD-1 inhibitors at the ESMO Immuno-Oncology Annual Congress in December 2024. In the fourth quarter of 2024, Elevation Oncology aims to begin dosing patients in the combination portion of the Phase 1 trial, investigating the drug's use with ramucirumab, a VEGFR2 inhibitor, and dostarlimab, a PD-1 inhibitor.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021 for treating advanced or metastatic gastric and GEJ cancer expressing Claudin 18.2. This designation is expected to facilitate more frequent interactions with the FDA, potentially expediting the drug's development and review process. The FDA’s Fast Track program is designed to speed up the development of treatments for serious conditions with unmet medical needs, and it might also make EO-3021 eligible for priority review and accelerated approval if supported by clinical data.

In financial terms, as of September 30, 2024, Elevation Oncology reported having $103.1 million in cash, cash equivalents, and marketable securities, up from $83.1 million at the end of 2023. This increase is partly due to the net proceeds of $44.2 million raised through its at-the-market (ATM) facility in the first half of 2024, offset by the cash used for operational activities. Research and development (R&D) expenses for the third quarter of 2024 were $9.4 million, up from $7.4 million in the third quarter of 2023. This rise in R&D expenses reflects the company's continuous investment in its leading and pipeline programs. General and administrative (G&A) expenses also increased slightly to $3.8 million from $3.5 million in the same period. Elevation Oncology reported a net loss of $12.9 million for the third quarter, compared to $10.6 million in the previous year’s third quarter.

Looking ahead, Elevation Oncology plans to nominate a development candidate for its HER3-ADC program by the fourth quarter of 2024. This program focuses on developing targeted therapies for cancers that overexpress HER3.

EO-3021 represents an innovative approach in cancer treatment. It is an antibody-drug conjugate designed to target Claudin 18.2, a protein found in certain cancer cells. The drug comprises an immunoglobulin G1 (IgG1) monoclonal antibody linked to a cytotoxic agent (monomethyl auristatin E or MMAE), which is intended to deliver the drug directly to the cancer cells while minimizing effects on healthy cells.

In conclusion, Elevation Oncology is making substantial progress in the development of EO-3021, and their efforts are supported by promising early data and strategic regulatory designations. The company remains committed to advancing its clinical programs and bringing new treatment options to patients with significant unmet medical needs.