On November 2, 2023 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, reported financial results for the third quarter ended September 30, 2023, and highlighted recent business achievements (Press release, Elevation Oncology, NOV 2, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-third-quarter-2023-financial-results-and-highlights-recent-business-achievements [SID1234636756]).
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"In the third quarter, we achieved a key milestone in our efforts to establish EO-3021 as a potential best-in-class anti-Claudin 18.2 ADC therapy, initiating patient enrollment in our Phase 1 clinical trial," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Claudin 18.2 is a validated target, expressed at varying levels in solid tumor types that affect millions of patients globally. As an ADC, EO-3021 is uniquely positioned to address a broad population by targeting tumors that express varying levels of Claudin 18.2, which may be inaccessible to other therapeutic approaches, while also potentially delivering improved efficacy and tolerability. As demonstrated by initial clinical data from our partner in China, we believe EO-3021 could deliver an important treatment option for patients."
Recent Business Achievements
In August 2023, Elevation Oncology began enrolling patients in its Phase 1 clinical trial of EO-3021 (NCT05980416). The Phase 1 clinical trial is an open-label, multi-center, dose escalation and expansion study designed to evaluate the safety, tolerability and preliminary anti-tumor activity of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers. An additional objective of the study is to assess the association of Claudin 18.2 expression and objective response. Elevation Oncology expects to report preliminary safety and anti-tumor activity data during the first half of 2025.
Third Quarter 2023 Financial Results
As of September 30, 2023, Elevation Oncology had cash, cash equivalents and marketable securities totaling $94.8 million, compared to $90.3 million as of December 31, 2022. The increase in cash reflects net proceeds of approximately $46.5 million from Elevation Oncology’s underwritten public offering, which closed in June 2023, partially offset by cash used to fund operating activities.
Research and development (R&D) expenses for the third quarter 2023 were $7.4 million, compared to $34.3 million for the third quarter 2022. The decrease in R&D expenses in the third quarter of 2023 was primarily due to the cost related to the license agreement between Elevation Oncology and a subsidiary of CSPC Pharmaceutical Group Limited for rights to develop and commercialize EO-3021, which was recorded in the third quarter of 2022.
General and administrative (G&A) expenses for the third quarter 2023 were $3.5 million, compared to $4.2 million for the third quarter 2022. The decrease in G&A expenses in the third quarter of 2023 was primarily due to a decrease in administrative costs, including directors’ and officers’ insurance.
Net loss for the third quarter 2023 was $10.6 million, compared to $38.8 million for the third quarter 2022.
Financial Outlook
Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of September 30, 2023, to be sufficient to fund its current operations into the second half of 2025.
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2. EO-3021is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with 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 transformations, 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 a Phase 1 study (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.