Elevation Oncology Reports Third Quarter 2023 Financial Results and Highlights Recent Business Achievements
- Elevation Oncology has initiated patient enrollment in the Phase 1 clinical trial for EO-3021, an anti-Claudin 18.2 ADC therapy.
- Preliminary safety and anti-tumor activity data for EO-3021 are expected in the first half of 2025.
- None.
-- Enrollment is ongoing in the Phase 1 clinical trial evaluating EO-3021 in patients with advanced solid tumors likely to express Claudin 18.2; preliminary safety and anti-tumor activity data expected in 1H 2025 --
"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
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
Research and development (R&D) expenses for the third quarter 2023 were
General and administrative (G&A) expenses for the third quarter 2023 were
Net loss for the third quarter 2023 was
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.
About Elevation Oncology, Inc.
Elevation Oncology is 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. We are rethinking drug development by seeking out innovative, selective cancer therapies that can be matched to a patient's unique tumor characteristics. Our lead candidate, EO-3021, is a potential best-in-class antibody drug conjugate (ADC) designed to target Claudin 18.2, a clinically validated molecular target. EO-3021 selectively delivers a cytotoxic payload directly to cancer cells expressing Claudin 18.2. We are evaluating EO-3021 in a Phase 1 study in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal, pancreatic or esophageal cancers. We are also exploring other opportunities through new or existing partnerships and business development opportunities to expand our oncology pipeline. For more information, visit www.ElevationOncology.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical development activities, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates, and the ability of Elevation Oncology's product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the continued presence of COVID-19 on Elevation Oncology's business, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Elevation Oncology Investor and Media Contact
Candice Masse, 978-879-7273
Senior Director, Corporate Communications & Investor Relations
cmasse@elevationoncology.com
Selected Financial Information | ||||||
Results of Operations (unaudited) | ||||||
Three months ended September 30, | ||||||
(In thousands, except share and per-share amounts) | 2023 | 2022 | ||||
Operating expenses: | ||||||
Research and development | $ | 7,422 | $ | 34,340 | ||
General and administrative | 3,498 | 4,191 | ||||
Total operating expenses | 10,920 | 38,531 | ||||
Loss from operations | (10,920) | (38,531) | ||||
Other income (expense), net | 295 | (306) | ||||
Loss before income taxes | (10,625) | (38,837) | ||||
Income tax expense | 11 | — | ||||
Net loss | (10,636) | (38,837) | ||||
Net loss per share, basic and diluted | $ | (0.25) | $ | (1.67) | ||
Weighted average common shares outstanding, basic and diluted | 42,402,489 | 23,290,249 | ||||
Selected Financial Information | ||
Consolidated Balance Sheets (unaudited) | ||
September 30, | December 31, | |
(in thousands): | 2023 | 2022 |
Cash, cash equivalents and marketable securities | ||
Prepaid expenses and other current assets | 4,000 | 2,697 |
Working Capital1 | 91,190 | 77,285 |
Total Assets | 99,975 | 94,161 |
Long-term debt, net of discount | 29,952 | 29,435 |
Total Stockholders' Equity | 62,416 | 49,032 |
1 We define working capital as current assets less current liabilities. |
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SOURCE Elevation Oncology
FAQ
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