Elevation Oncology Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Achievements
- Elevation Oncology dosed the first patient in Japan in the ongoing Phase 1 clinical trial of EO-3021.
- Preclinical proof-of-concept data for the HER3-ADC program will be presented at the AACR Annual Meeting.
- Elevation Oncology raised approximately $17.0M in net proceeds through an ATM facility and refinanced its debt facility with K2 Health Ventures.
- The company's cash runway is expected to last into the fourth quarter of 2025.
- Elevation Oncology appointed three new members to its Board of Directors, bringing diverse expertise to the team.
- The company's financial results for Q4 2023 show a decrease in cash used to fund operating activities, with net proceeds from a public offering and an ATM facility.
- Research and development expenses decreased in Q4 2023 compared to Q4 2022, primarily due to changes in clinical trial expenses.
- General and administrative expenses also decreased in Q4 2023 compared to Q4 2022, mainly due to reduced administrative costs.
- Elevation Oncology's net loss for Q4 2023 decreased compared to Q4 2022.
- The company's existing cash, together with the net proceeds raised, is expected to fund operations into Q4 2025.
- None.
Insights
An Oncology Doctor would assess the potential impact of Elevation Oncology's EO-3021 and HER3-ADC programs from a medical perspective. The expansion of the EO-3021 Phase 1 clinical trial into Japan is significant given the higher prevalence of gastric cancer in the region. This could lead to more comprehensive data on the drug's safety and efficacy, potentially speeding up the regulatory approval process if results are positive. Moreover, the nomination of a development candidate for the HER3-ADC program in 2024 signals progress in addressing a variety of HER3-expressing cancers, which could fill a therapeutic gap and benefit patients with limited treatment options.
A Financial Analyst would focus on the financial implications of the reported activities. The successful fundraising through the at-the-market (ATM) facility, which raised $17.0 million in net proceeds and the refinancing of the debt facility with K2 Health Ventures, extending the interest-only payment period, are positive indicators of Elevation Oncology's financial health. This suggests a strategic approach to managing cash flow, which is crucial for a biotech company in the clinical development stage. The company's forecasted cash runway into Q4 2025 provides a buffer for continuing R&D activities without the immediate need for further financing, which is favorable for maintaining shareholder value and avoiding dilution in the short term.
A Market Research Analyst would evaluate the market potential of Elevation Oncology's pipeline. The targeting of Claudin 18.2 and HER3-expressing tumors addresses unmet needs in solid tumor oncology, a market with a significant patient population and a high demand for innovative treatments. The geographic expansion into Japan not only diversifies the potential market but also indicates a strategic move to capitalize on specific regional medical needs. The preclinical data presentation at the AACR Annual Meeting could generate interest among potential collaborators and investors, which is crucial for a company seeking to position itself as a leader in ADC therapies for solid tumors.
--Expanded ongoing Phase 1 clinical trial of EO-3021 globally, dosing first patient in
-- Preclinical proof-of-concept data for HER3-ADC program to be presented at AACR Annual Meeting; plan to nominate development candidate in 2024 –
-- Raised approximately
"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
"In parallel, we continue to advance our HER3-ADC program and look forward to sharing preclinical proof-of-concept data at AACR 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) 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 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
Research and development (R&D) expenses for the fourth quarter of 2023 were
General and administrative (G&A) expenses for the fourth quarter of 2023 were
Net loss for the fourth quarter of 2023 was
Financial Outlook
Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of December 31, 2023, together with the approximately
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 leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. 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 and preclinical development activities, expected timing of announcements of clinical and preclinical results and trial details, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates, the ability of Elevation Oncology's product candidates to treat their targeted indications and Elevation Oncology's expectations about its cash runway. 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," "possible," "potential," "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, 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 (In thousands, except share and per share data) (unaudited) | ||||||||||||
Year ended December 31, | Three months ended December 31, | |||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||
Statement of Operations items: | ||||||||||||
Research and development | $ | 25,434 | $ | 78,717 | $ | 4,691 | $ | 14,502 | ||||
General and administrative | 14,904 | 15,832 | 3,255 | 4,035 | ||||||||
Restructuring charges | 5,107 | — | — | — | ||||||||
Total operating expenses | 45,445 | 94,549 | 7,946 | 18,537 | ||||||||
Loss from operations | (45,445) | (94,549) | (7,946) | (18,537) | ||||||||
Other income (expenses), net | (229) | (506) | 56 | (480) | ||||||||
Loss before income taxes | (45,674) | (95,055) | (7,890) | (19,017) | ||||||||
Income tax expense | 30 | 25 | 9 | 25 | ||||||||
Net loss | $ | (45,704) | $ | (95,080) | $ | (7,899) | $ | (19,042) | ||||
Net loss per share, basic and diluted | $ | (1.34) | $ | (4.09) | $ | (0.19) | $ | (0.82) | ||||
Weighted average common shares outstanding, basic and diluted | 34,077,675 | 23,267,120 | 42,416,011 | 23,302,066 | ||||||||
Selected Financial Information (In thousands, except share and per share data) (unaudited) | ||||||
December 31, | ||||||
Selected Balance Sheet items: | 2023 | 2022 | ||||
Cash, cash equivalents and marketable securities | $ | 83,107 | $ | 90,280 | ||
Working capital1 | 83,819 | 77,285 | ||||
Total assets | 89,091 | 94,161 | ||||
Long-term debt, net of discount | 30,137 | 29,435 | ||||
Total stockholders' equity | 54,809 | 49,032 | ||||
1 We define working capital as current assets less current liabilities. | ||||||
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SOURCE Elevation Oncology
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