On November 3, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, reported financial results for the quarter ended September 30, 2022, and highlighted recent progress (Press release, Elevation Oncology, NOV 3, 2022, https://elevationoncology.com/elevation-oncology-reports-third-quarter-2022-financial-results-and-highlights-recent-company-progress/?utm_source=rss&utm_medium=rss&utm_campaign=elevation-oncology-reports-third-quarter-2022-financial-results-and-highlights-recent-company-progress [SID1234622946]).
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"Our newly expanded pipeline provides an opportunity to continue building an industry leading precision oncology company for patients with genomically defined cancers and significant unmet medical needs. We remain focused on execution, as we continue enrolling and treating patients in the ongoing Phase 2 CRESTONE study evaluating seribantumab," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We are also committed to bringing EO-3021, our differentiated ADC targeting Claudin18.2 into the clinic and plan to initiate a Phase 1 clinical trial in the US in patients with solid tumors in 2023."
Recent Progress and Highlights
Seribantumab
On track to report additional interim data from Cohort 1 of the CRESTONE study in the first half of 2023. CRESTONE is a Phase 2 potential registration-enabling study evaluating seribantumab in patients with solid tumors harboring NRG1 gene fusions. Initial data presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showed positive clinical proof-of-concept data supporting the potential of seribantumab to induce deep and durable benefit for patients.
EO-3021
Phase 1 clinical trial in the US to evaluate EO-3021 in solid tumors expected to initiate in 2023. In July 2022, Elevation Oncology expanded its pipeline through the licensing of EO-3021, a differentiated, clinical-stage antibody-drug conjugate (ADC) that binds to Claudin18.2 and delivers a cytotoxic payload to eliminate tumor cells. Claudin18.2 is a clinically validated oncology target expressed in several solid tumor types including many gastrointestinal cancers such as gastric, gastroesophageal junction, and pancreatic cancer. Our collaboration partner, CSPC Pharmaceutical Group (HKEX: 01093) is currently conducting a Phase 1, dose escalation clinical trial in China in patients with solid tumors.
Expected Upcoming Milestones and Operational Objectives
Additional interim seribantumab data from the Phase 2 CRESTONE study are expected in the first half of 2023
Phase 1 clinical trial in the US to evaluate EO-3021 expected to initiate in 2023
Topline data for seribantumab from the Phase 2 CRESTONE study results are expected in 2024
Ongoing target evaluation and continued execution of the Company’s strategy for future pipeline expansion
Third Quarter 2022 Financial Results
As of September 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $107.9 million, compared to $122.5 million as of June 30, 2022.
Research and development expenses for the third quarter 2022 were $34.3 million, compared to $9.3 million for the third quarter 2021. The increase in R&D expense was primarily related to a one-time upfront license fee of $27.0 million paid to CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited, for the exclusive rights to develop and commercialize EO-3021 outside of Greater China.
General and administrative expenses for the third quarter 2022 were $4.2 million, compared to $3.0 million for the third quarter 2021. The increase in G&A expense was primarily related to personnel costs, professional services and other administrative costs.
Net loss for the third quarter 2022 was $38.8 million, compared to $12.3 million for the third quarter 2021.
Financial Outlook
Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of September 30, 2022, will be sufficient to fund its current operations into 2024.