On March 6, 2024 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 quarter and full-year ended December 31, 2023, and highlighted recent business achievements (Press release, Elevation Oncology, MAR 6, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-fourth-quarter-and-full-year-2023-financial-results-and-highlights-recent-business-achievements [SID1234640852]).
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"We are entering 2024 with tremendous momentum across our pipeline of differentiated ADC therapies," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "We continue to advance EO-3021 and remain on-track to share an update from our Phase 1 clinical trial mid-year, as well as details on our combination strategy in the months ahead. In addition, we recently expanded our Phase 1 clinical trial into Japan, a geography with a particularly high prevalence of gastric cancer. This will allow us to potentially address a significant unmet need for new gastric cancer therapies outside of the U.S., while also enabling us to characterize the safety and efficacy profile of our anti-Claudin 18.2 agent in a diverse patient population."
"In parallel, we continue to advance our HER3-ADC program and look forward to sharing preclinical proof-of-concept data at AACR (Free AACR Whitepaper) next month, which highlight the promising therapeutic potential of our program and support our plans to nominate a development candidate later this year. We look forward to continuing our efforts to advance important therapies for patients with significant unmet medical needs."
Recent Business Achievements
EO-3021: A differentiated antibody-drug conjugate (ADC) for the treatment of patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers.
In February 2024, Elevation Oncology dosed the first patient in Japan in the ongoing Phase 1 clinical trial of EO-3021.
HER3-ADC: A HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3.
In March 2024, Elevation Oncology announced plans to present preclinical proof of concept data from its HER3-targeting ADC program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 5-10, 2024, in San Diego, CA. The abstract includes proof-of-concept data from in vitro and in vivo studies, which highlight the therapeutic potential of Elevation Oncology’s HER3-ADC program across a range of HER3-expressing cancers.
Corporate:
Elevation Oncology recently announced the appointment of three new members to its Board of Directors.
Darcy Mootz., Ph.D. – Dr. Mootz is an experienced life sciences executive, who brings expertise across corporate strategy, corporate development, finance, and operations to the Board.
Julie M. Cherrington, Ph.D. – Dr. Cherrington is an experienced life sciences executive, who brings insights and extensive experience advancing novel product candidates into the clinic and through commercialization to the Board.
Alan Sandler, M.D. – Dr. Sandler is an accomplished leader in oncology and drug development, who brings experience leading clinical development and operations, regulatory affairs, drug safety and asset development strategy across industry and academia to the Board.
In March 2024, Elevation Oncology refinanced its debt facility with existing lender, K2 HealthVentures (K2HV). Under the refinanced debt facility, the interest-only payment period was extended from March 1, 2025, to June 1, 2026. Elevation Oncology issued a new common stock purchase warrant to an affiliate of K2HV, and certain terms relating to the lenders’ conversion election were amended.
Expected Upcoming Milestones:
EO-3021:
Share detail on planned Phase 1 combination study evaluating EO-3021 in the first half of 2024.
Provide update from ongoing Phase 1 clinical trial of EO-3021 in mid-2024, with additional data expected in the first half of 2025.
HER3-ADC:
Present preclinical proof-of-concept data on HER3-ADC program at the AACR (Free AACR Whitepaper) Annual Meeting in April 2024.
Nominate development candidate from HER3-ADC program in 2024.
Fourth Quarter and Full Year 2023 Financial Results
As of December 31, 2023, Elevation Oncology had cash, cash equivalents and marketable securities totaling $83.1 million, compared to $90.3 million as of December 31, 2022. The decrease in cash reflects cash used to fund operating activities, partially offset by net proceeds of approximately $46.5 million from Elevation Oncology’s underwritten public offering, which closed in June 2023. Subsequent to year-end, Elevation Oncology raised net proceeds of approximately $17.0 million through its at-the-market (ATM) facility.
Research and development (R&D) expenses for the fourth quarter of 2023 were $4.7 million, compared to $14.5 million for the fourth quarter of 2022. The decrease in R&D expenses in the fourth quarter of 2023 was primarily due to decreased clinical trial expenses associated with Elevation Oncology’s former lead program, partially offset by increased clinical trial expenses associated with the EO-3021 clinical trial. For the year ended December 31, 2023, R&D expenses were $25.4 million, compared to $78.7 million for the year ended December 31, 2022. The decrease 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, and decreased clinical trial expenses associated with Elevation Oncology’s former lead program, partially offset by increased clinical trial expenses associated with the EO-3021 clinical trial.
General and administrative (G&A) expenses for the fourth quarter of 2023 were $3.3 million, compared to $4.0 million for the fourth quarter of 2022. The decrease in G&A expenses in the fourth quarter of 2023 was primarily due to decreased administrative costs, including directors’ and officers’ insurance, and decreased personnel costs, including stock-based compensation. For the year ended December 31, 2023, G&A expenses were $14.9 million, compared to $15.8 million for the year ended December 31, 2022. The decrease was primarily related to a decrease in administrative costs, including directors’ and officers’ insurance.
Net loss for the fourth quarter of 2023 was $7.9 million, compared to $19.0 million for the fourth quarter of 2022.
Financial Outlook
Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of December 31, 2023, together with the approximately $17.0 million in net proceeds raised under its ATM facility, to be sufficient to fund its current operations into the fourth quarter of 2025.