On August 3, 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 second quarter ended June 30, 2023, and highlighted recent business achievements (Press release, Elevation Oncology, AUG 3, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-second-quarter-2023-financial-results-and-highlights-recent-business-achievements [SID1234633744]).

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"The compelling initial clinical data presented at ASCO (Free ASCO Whitepaper) 2023 by our partner CSPC Pharmaceutical Group Limited (CSPC) are further evidence for why we believe EO-3021 to be a differentiated and potentially best-in-class antibody-drug conjugate targeting cancer cells expressing Claudin 18.2," said Joseph Ferra, Chief Executive Officer of Elevation Oncology. "In June, we successfully completed a public offering securing $46.5 million in net proceeds, providing us with the necessary capital to execute against our EO-3021 development strategy where we anticipate dosing the first patient during the second half of this year."

Recent Business Achievements

Corporate

Appointed Joseph Ferra and Tammy Furlong as Chief Executive Officer and Chief Financial Officer, respectively. Mr. Ferra was previously Interim Chief Executive Officer and Chief Financial Officer. Ms. Furlong was promoted from her previous role as Vice President of Finance and Accounting. Mr. Ferra also joined the Elevation Oncology Board of Directors.
Secured $46.5 million in net proceeds in public offering. In June 2023, Elevation Oncology closed an underwritten public offering which yielded net proceeds of $46.5 million, after deducting underwriting discounts and commissions and other offering expenses.
EO-3021

Highlighted first-in-human Phase 1 clinical data of SYSA1801 (EO-3021) the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting. CSPC announced promising initial clinical data for SYSA1801 (EO-3021) in a poster presentation. Initial data showed promising signs of efficacy, including a 47.1% objective response rate (ORR), with eight partial responses (PRs), including four confirmed PRs, and a 64.7% disease control rate in patients with resistant/refractory gastric cancer expressing Claudin 18.2, along with a well-tolerated safety profile. These data will inform Elevation Oncology’s Phase 1 study, which is expected to commence during the second half of 2023, where Elevation Oncology will enroll patients with solid tumors likely to express Claudin 18.2. The dose escalation and expansion portion of the study in China is ongoing.
Other Pipeline Programs

Continue research and development efforts to advance novel therapeutic drug candidates and targets. Additional pipeline programs include those through Elevation Oncology’s existing partnership with Caris Life Sciences.
Expected Upcoming Milestones and Operational Objectives

Initiate Phase 1 clinical trial of EO-3021 in the United States in the second half of 2023
Ongoing target evaluation for future pipeline expansion
Second Quarter 2023 Financial Results

As of June 30, 2023, Elevation Oncology had cash, cash equivalents and marketable securities totaling $107.9 million, inclusive of net proceeds from the underwritten public offering that closed in June 2023, compared to $90.3 million as of December 31, 2022.

Research and development (R&D) expenses for the second quarter 2023 were $6.0 million, compared to $16.3 million for the second quarter 2022. The decrease in R&D expenses in the second quarter 2023 was primarily due to the decrease in costs related to manufacturing clinical supply of seribantumab for use in the CRESTONE clinical trial.

General and administrative (G&A) expenses for the second quarters of 2023 and 2022 were $3.8 million.

Net loss for the second quarter 2023 was $10.1 million, compared to $19.9 million for the second quarter 2022.

Financial Outlook

Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of June 30, 2023, will 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 and is 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 transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. An Investigational New Drug application for EO-3021 has been cleared by the U.S. Food and Drug Administration.