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Elevation Oncology(ELEV) - 2024 Q4 - Annual Results
2025-03-06 21:52
Financial Performance - As of December 31, 2024, Elevation Oncology had cash, cash equivalents, and marketable securities totaling $93.2 million, an increase from $83.1 million as of December 31, 2023, reflecting net proceeds of $44.2 million raised through its at-the-market facility[5]. - The net loss for the fourth quarter of 2024 was $10.4 million, compared to a net loss of $7.9 million for the fourth quarter of 2023[8]. - Elevation Oncology's total operating expenses for the year ended December 31, 2024, were $44.7 million, slightly down from $45.4 million in 2023[15]. Research and Development - Research and development (R&D) expenses for the fourth quarter of 2024 were $6.6 million, up from $4.7 million in the fourth quarter of 2023, with total R&D expenses for the year at $28.6 million compared to $25.4 million in 2023[6]. - Preclinical data for HER3 ADC EO-1022 will be presented at the AACR Annual Meeting in the second quarter of 2025, with an IND application planned for 2026[10]. - Elevation Oncology expects to report additional safety and efficacy data from the ongoing Phase 1 clinical trial of monotherapy EO-3021 in the second quarter of 2025[10]. - Initial data from the combination cohorts of the Phase 1 clinical trial of EO-3021 is expected to be reported in the fourth quarter of 2025 or the first quarter of 2026[10]. - The company implemented prospective Claudin 18.2 expression testing in January 2025 as part of the patient screening process for its ongoing Phase 1 trial of EO-3021[3]. Clinical Trial Results - The combination of EO-3021 with a PD-1 inhibitor showed a tumor growth inhibition (TGI) of 79.9%, compared to 33.8% for EO-3021 alone[9]. General and Administrative Expenses - General and administrative (G&A) expenses for the fourth quarter of 2024 were $4.0 million, compared to $3.3 million in the fourth quarter of 2023, with total G&A expenses for the year at $16.1 million versus $14.9 million in 2023[7].
Elevation Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Business Achievements
Prnewswire· 2025-03-06 21:30
Core Insights - Elevation Oncology is advancing its Claudin 18.2 ADC program, EO-3021, for advanced gastric/gastroesophageal junction cancer, with initial data from combination cohorts expected in Q4 2025 or Q1 2026 [1][2] - The company has implemented prospective Claudin 18.2 testing in its ongoing Phase 1 trial to better identify patients likely to benefit from EO-3021 [2][3] - Financial results for the year ended December 31, 2024, show an increase in cash reserves and R&D expenses, reflecting ongoing investment in clinical trials [5][6][14] Clinical Development - EO-3021 is currently being evaluated in combination with dostarlimab and ramucirumab in Phase 1 clinical trials [1][3] - Preclinical data presented at ESMO-IO 2024 demonstrated superior tumor growth inhibition when EO-3021 was combined with either a PD-1 inhibitor or a VEGFR2 inhibitor [3] - The company plans to file an Investigational New Drug (IND) application for its HER3 ADC, EO-1022, in 2026 [1][4][11] Financial Performance - As of December 31, 2024, Elevation Oncology reported cash, cash equivalents, and marketable securities totaling $93.2 million, up from $83.1 million in 2023 [5][14] - R&D expenses for Q4 2024 were $6.6 million, an increase from $4.7 million in Q4 2023, driven by clinical trial costs [6][13] - The net loss for Q4 2024 was $10.4 million, compared to $7.9 million in Q4 2023 [8][13] Upcoming Milestones - The company expects to report additional safety and efficacy data from the EO-3021 monotherapy trial in Q2 2025 [11] - Initial data from the combination cohorts of the EO-3021 trial is anticipated in Q4 2025 or Q1 2026 [1][11] - Preclinical data for EO-1022 will be presented at the AACR Annual Meeting in 2025 [1][11]
Elevation Oncology(ELEV) - 2024 Q4 - Annual Report
2025-03-06 21:17
Table of Contents For The Transition Period From To Commission file number: 001-40523 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ELEVATION ONCOLOGY, INC. Indicate by check mark if the registrant is not required to file reports pursuant to Section 1 ...
Elevation Oncology Provides Updates on Differentiated ADC Programs and Upcoming Milestones
Prnewswire· 2025-01-13 12:30
-- Initiated dosing in Phase 1 clinical trial cohort evaluating Claudin 18.2 ADC EO-3021 in combination with ramucirumab or dostarlimab in patients with advanced gastric/gastroesophageal junction (GEJ) cancer -- -- Expect to report initial data from combination cohort in 4Q 2025 or 1Q 2026 ---- On-track to report additional monotherapy data from dose escalation and expansion cohorts of ongoing Phase 1 clinical trial in 1H 2025 ---- Plan to present preclinical data for HER3 ADC EO-1022 in 1H 2025 and file an ...
Elevation Oncology Presents Preclinical Proof-of-Concept Data Supporting Combination Potential of EO-3021 with VEGFR2 or PD-1 Inhibitors at ESMO Immuno-Oncology Annual Congress 2024
Prnewswire· 2024-12-05 12:30
Core Insights - Elevation Oncology announced new preclinical data supporting the combination of EO-3021 with VEGFR2 or PD-1 inhibitors, demonstrating enhanced anti-tumor activity [1][2] - The company plans to initiate dosing in the combination portion of its ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter of 2024 [1][3] Preclinical Data - EO-3021 combined with DC101 (a VEGFR2 inhibitor surrogate) showed tumor growth inhibition (TGI) of 88.2%, significantly higher than 20.1% for EO-3021 alone and 59.2% for DC101 alone [2] - The combination of EO-3021 with a PD-1 inhibitor resulted in a TGI of 79.9%, compared to 33.8% for EO-3021 alone and 25.0% for the PD-1 inhibitor alone [2] - 92% of mice treated with the EO-3021 and PD-1 inhibitor combination achieved a complete response (CR), compared to 50% for EO-3021 monotherapy and 17% for the PD-1 inhibitor alone [2] Clinical Trial Plans - The ongoing Phase 1 clinical trial will evaluate EO-3021 in combination with ramucirumab (a VEGFR2 inhibitor) in the second-line setting and with dostarlimab (a PD-1 inhibitor) in the front-line setting [3][6] - Elevation Oncology continues to enroll patients in the monotherapy dose expansion portion of the trial, with additional data expected in the first half of 2025 [3] Regulatory Designations - EO-3021 received Fast Track designation from the FDA for treating advanced or metastatic gastric/GEJ cancer expressing Claudin 18.2 [7] - The drug also holds orphan drug designation for gastric cancer since November 2020 and for pancreatic cancer since May 2021 [7] Company Overview - Elevation Oncology focuses on developing selective cancer therapies for solid tumors with significant unmet medical needs, leveraging expertise in antibody-drug conjugates (ADCs) [9] - The lead candidate, EO-3021, targets Claudin 18.2 and is currently in a Phase 1 trial for advanced gastric/GEJ adenocarcinoma [9]
Elevation Oncology to Present at the Piper Sandler 36th Annual Healthcare Conference
Prnewswire· 2024-11-26 12:30
BOSTON, Nov. 26, 2024 /PRNewswire/ -- 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, today announced that Joseph J. Ferra, President and Chief Executive Officer of Elevation Oncology, will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024, at 8:30 a.m. ET.A live w ...
Elevation Oncology(ELEV) - 2024 Q3 - Quarterly Results
2024-11-06 12:45
Exhibit 99.1 Elevation Oncology Reports Third Quarter 2024 Financial Results and Highlights Recent Business Achievements -- Promising initial Phase 1 data of EO-3021 reported in August highlighting 42.8% confirmed ORR observed in Claudin 18.2-enriched subset of gastric and GEJ cancer, with differentiated safety profile -- -- Progressed into dose expansion portion of Phase 1 trial; additional monotherapy data expected in 1H 2025 -- -- Expect to present preclinical data on the combination potential of EO-3021 ...
Elevation Oncology Reports Third Quarter 2024 Financial Results and Highlights Recent Business Achievements
Prnewswire· 2024-11-06 12:30
-- Promising initial Phase 1 data of EO-3021 reported in August highlighting 42.8% confirmed ORR observed in Claudin 18.2-enriched subset of gastric and GEJ cancer, with differentiated safety profile ---- Progressed into dose expansion portion of Phase 1 trial; additional monotherapy data expected in 1H 2025 ---- Expect to present preclinical data on the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at ESMO Immuno-Oncology Annual Congress 2024 (ESMO-IO 2024) ---- Expect to initiate dosing ...
Elevation Oncology(ELEV) - 2024 Q3 - Quarterly Report
2024-11-06 12:00
[Part I Financial Information](index=5&type=section&id=Part%20I%20Financial%20Information) [Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) These unaudited statements provide a snapshot of Elevation Oncology's financial position, operations, and cash flows as of and for the period ended September 30, 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show an increase in total assets and stockholders' equity as of September 30, 2024, primarily due to marketable securities and equity offerings, alongside a rise in total liabilities Condensed Consolidated Balance Sheet Summary (in thousands) | Account | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $48,202 | $49,255 | | Marketable securities | $54,868 | $33,852 | | **Total Assets** | **$106,302** | **$89,091** | | **Liabilities & Equity** | | | | Total current liabilities | $5,926 | $4,145 | | Long-term debt, net | $31,021 | $30,137 | | **Total Liabilities** | **$36,947** | **$34,282** | | **Total Stockholders' Equity** | **$69,355** | **$54,809** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements of operations show a reduced net loss for the nine months ended September 30, 2024, primarily due to the absence of prior-year restructuring charges, despite increased research and development expenses driven by the EO-3021 program Statement of Operations Summary (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Research and development | $21,950 | $20,743 | | General and administrative | $12,111 | $11,649 | | Restructuring charges | $0 | $5,107 | | **Loss from operations** | **($34,061)** | **($37,499)** | | **Net loss** | **($34,049)** | **($37,805)** | | **Net loss per share** | **($0.60)** | **($1.14)** | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statements indicate net cash used in operating and investing activities, largely offset by cash provided from financing activities, resulting in a net decrease in cash and cash equivalents for the nine months ended September 30, 2024 Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($26,162) | ($43,999) | | Net cash (used in) provided by investing activities | ($19,833) | $4,983 | | Net cash provided by financing activities | $44,942 | $47,977 | | **(Decrease) increase in cash** | **($1,053)** | **$8,961** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed disclosures on the company's business, significant accounting policies, liquidity, debt arrangements, equity offerings, and contingent milestone payment obligations from licensing agreements - The company is focused on developing antibody-drug conjugates (ADCs), with its lead candidate EO-3021 targeting Claudin 18.2 in a Phase 1 trial and a second program targeting HER3[20](index=20&type=chunk) - As of September 30, 2024, the company had **$103.1 million** in cash, cash equivalents, and marketable securities, expected to fund operations for at least the next 12 months[23](index=23&type=chunk) - In March 2024, the company amended its loan agreement with K2 HealthVentures, extending the interest-only period to June 1, 2026, and issuing additional warrants, resulting in a **$0.9 million** loss from debt extinguishment[57](index=57&type=chunk)[66](index=66&type=chunk) - The company has significant potential future milestone payment obligations, including up to **$148.0 million** for development/regulatory milestones and **$1.0 billion** for commercial milestones for EO-3021, plus up to **$365.5 million** for its HER3-ADC program[101](index=101&type=chunk)[117](index=117&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=40&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, detailing business strategy, financial performance, liquidity, and critical accounting policies [Business Overview](index=40&type=section&id=Business%20Overview) Elevation Oncology is an innovative oncology company focused on developing antibody-drug conjugates (ADCs), with its lead candidate EO-3021 in Phase 1 trials and plans for combination therapies and a second HER3-ADC program - The lead product candidate, EO-3021, a Claudin 18.2-targeting ADC, is in a Phase 1 clinical trial for solid tumors and has received Fast Track designation from the FDA for gastric and GEJ cancer[124](index=124&type=chunk) - Initial Phase 1 data for EO-3021 in gastric/GEJ cancer patients showed an objective response rate (ORR) of **42.8%** and a disease control rate (DCR) of **71.4%** in the higher Claudin 18.2 expression sub-group[132](index=132&type=chunk)[133](index=133&type=chunk) - The company plans to expand the EO-3021 Phase 1 trial to evaluate combinations with ramucirumab (VEGFR2 inhibitor) and dostarlimab (PD-1 inhibitor), with dosing expected by year-end 2024[126](index=126&type=chunk) - The second program is a HER3-targeting ADC, with plans to nominate a development candidate in the second half of 2024[136](index=136&type=chunk) [Results of Operations](index=51&type=section&id=Results%20of%20Operations) Operating results for the nine months ended September 30, 2024, show a decreased net loss primarily due to the absence of prior-year restructuring charges, despite increased research and development expenses driven by the EO-3021 program Comparison of Results of Operations (in thousands) | Period | Research & Development | General & Administrative | Restructuring Charges | Net Loss | | :--- | :--- | :--- | :--- | :--- | | **Q3 2024** | $9,388 | $3,841 | $0 | $(12,881) | | **Q3 2023** | $7,422 | $3,498 | $0 | $(10,636) | | **9M 2024** | $21,950 | $12,111 | $0 | $(34,049) | | **9M 2023** | $20,743 | $11,649 | $5,107 | $(37,805) | - The **$2.0 million** increase in R&D expenses for Q3 2024 vs Q3 2023 was primarily due to a **$2.5 million** expense for in-licensing technology and a **$1.9 million** increase in EO-3021 program costs, partially offset by a **$2.4 million** decrease in manufacturing costs[156](index=156&type=chunk) - The net loss for the nine months ended Sep 30, 2024, decreased by **$3.8 million** compared to the prior year, primarily due to the absence of **$5.1 million** in restructuring charges incurred in 2023[161](index=161&type=chunk)[164](index=164&type=chunk) [Liquidity and Capital Resources](index=55&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2024, the company held **$103.1 million** in cash and marketable securities, expected to fund operations into 2026, with past funding primarily from equity offerings and a debt facility - The company believes its cash, cash equivalents, and marketable securities totaling **$103.1 million** as of September 30, 2024, will be sufficient to fund operations into 2026[170](index=170&type=chunk)[180](index=180&type=chunk) Cash Flow Summary for Nine Months Ended Sep 30, 2024 (in thousands) | Activity | Amount | | :--- | :--- | | Cash used in operating activities | $(26,162) | | Cash used in investing activities | $(19,833) | | Cash provided by financing activities | $44,942 | - During the nine months ended September 30, 2024, the company raised net proceeds of approximately **$44.2 million** from its at-the-market (ATM) offering[170](index=170&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=63&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and marketable securities, though a 10% change is not expected to have a material effect, and there is no significant foreign currency risk - The company's main market risk is interest rate sensitivity on its **$103.1 million** of cash, cash equivalents, and marketable securities, where a **10%** change in interest rates is not expected to have a material effect[193](index=193&type=chunk) [Controls and Procedures](index=63&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2024, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of September 30, 2024[197](index=197&type=chunk) - No material changes in internal control over financial reporting occurred during the third quarter of 2024[198](index=198&type=chunk) [Part II Other Information](index=66&type=section&id=Part%20II%20Other%20Information) [Legal Proceedings](index=66&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings to disclose for the period - The company reports no legal proceedings[200](index=200&type=chunk) [Risk Factors](index=66&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including limited operating history, high dependency on lead product candidate EO-3021, clinical trial challenges, regulatory hurdles, reliance on third-party manufacturers, competition, intellectual property protection, and stock price volatility - The company has a limited operating history, has incurred **$230.0 million** in accumulated deficit as of September 30, 2024, and expects to incur continued losses[203](index=203&type=chunk)[214](index=214&type=chunk) - The business is highly dependent on the success of its lead product candidate, EO-3021, which has not completed clinical development[204](index=204&type=chunk)[238](index=238&type=chunk) - The company relies on third parties, including some in China, for clinical supply manufacturing, increasing risks related to supply chain, quality, and geopolitical tensions[209](index=209&type=chunk)[373](index=373&type=chunk)[374](index=374&type=chunk) - In September 2024, the company received a Nasdaq notice for failing to meet the **$1.00** minimum bid price requirement, potentially leading to delisting[557](index=557&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=179&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities in the period[573](index=573&type=chunk) [Defaults Upon Senior Securities](index=179&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - There were no defaults upon senior securities[573](index=573&type=chunk) [Mine Safety Disclosures](index=179&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[573](index=573&type=chunk) [Other Information](index=179&type=section&id=Item%205.%20Other%20Information) The company reports no other information for the period - None[573](index=573&type=chunk) [Exhibits](index=180&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with the Form 10-Q, including CEO and CFO certifications and XBRL data files - The report includes required certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32) and XBRL interactive data files[575](index=575&type=chunk)
What Makes Elevation Oncology (ELEV) a New Strong Buy Stock
ZACKS· 2024-10-10 17:05
Core Viewpoint - Elevation Oncology, Inc. (ELEV) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which have a strong correlation with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Company Performance Indicators - For the fiscal year ending December 2024, Elevation Oncology is expected to earn -$0.82 per share, reflecting a 38.8% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for Elevation Oncology has increased by 11.3%, indicating a positive trend in earnings outlook [8]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 5% of Zacks-covered stocks receive a 'Strong Buy' rating, highlighting the superior earnings estimate revision feature of these stocks [10].