Elevation Oncology, Inc. (ELEV) Bundle
A Brief History of Elevation Oncology
Elevation Oncology, Inc., founded in 2019, is a clinical-stage biotechnology company focused on developing targeted therapies for patients with genomically defined cancers. The company’s lead product candidate, EO-3021, is a monoclonal antibody designed for the treatment of various solid tumors driven by neuregulin-1 (NRG1) fusions.
Company Milestones
- 2019: Elevation Oncology was established with a focus on precision medicine in oncology.
- 2020: The company announced the initiation of clinical trials for EO-3021.
- 2021: Completed a Series B financing round, raising $60 million to support its clinical programs.
- 2022: Entered into a license agreement with CSPC Pharmaceutical Group for the development of EO-3021, paying a one-time upfront fee of $27 million.
- 2023: Paused the clinical development of seribantumab to prioritize resources towards EO-3021.
- September 2024: Announced a license agreement for technology related to its HER3-ADC program, with potential milestone payments up to $365.5 million.
Financial Performance
As of September 30, 2024, Elevation Oncology reported the following financial metrics:
| Metric | 2024 (9 months) | 2023 (9 months) | Change |
|---|---|---|---|
| Research and Development Expenses | $21.95 million | $20.74 million | $1.21 million |
| General and Administrative Expenses | $12.11 million | $11.65 million | $0.46 million |
| Total Operating Expenses | $34.06 million | $37.50 million | $(3.44) million |
| Net Loss | $(34.05) million | $(37.81) million | $3.76 million |
| Cash and Marketable Securities | $103.1 million | — | — |
Stock Performance
As of September 30, 2024, the company had approximately 59.12 million shares outstanding, following the exercise of various warrants and options. The weighted average common stock outstanding for the nine months ended was 56.65 million shares.
Future Outlook
Elevation Oncology anticipates continued investment in EO-3021 and related clinical trials. The company expects to incur significant operating losses as it advances its product candidates through clinical development. The estimated future capital requirements will depend largely on the progress of clinical trials and potential partnerships for commercialization.
Recent Developments
In the latest quarterly report, the company highlighted its ongoing efforts to raise additional capital and manage operational expenditures effectively. The total interest expense for the nine months ended September 30, 2024, was $3.0 million, reflecting the company's financing strategies amidst its development phase.
The company’s stock performance has been influenced by its strategic decisions, clinical trial outcomes, and partnerships, with a net loss per share of $(0.60) for the nine months ended September 30, 2024.
A Who Owns Elevation Oncology, Inc. (ELEV)
Major Shareholders
As of September 30, 2024, the ownership structure of Elevation Oncology, Inc. (ELEV) reflects a combination of institutional and individual investors. The company has a total of 59,119,055 shares of common stock outstanding.
| Shareholder Type | Number of Shares | Percentage Ownership |
|---|---|---|
| Institutional Investors | 38,250,000 | 64.6% |
| Insider Ownership | 7,000,000 | 11.8% |
| Public Float | 13,869,055 | 23.6% |
Institutional Investors
The institutional ownership of Elevation Oncology includes several prominent investment firms. As of the latest filings, the following institutions hold significant stakes:
| Institution | Shares Owned | Percentage of Total Shares |
|---|---|---|
| BlackRock, Inc. | 10,000,000 | 16.9% |
| Vanguard Group, Inc. | 8,000,000 | 13.5% |
| State Street Corporation | 6,000,000 | 10.1% |
| Fidelity Investments | 4,250,000 | 7.2% |
Insider Ownership
Insider ownership includes shares held by executives and board members. The following table outlines the key insiders and their holdings:
| Name | Position | Shares Owned |
|---|---|---|
| Dr. Jennifer R. Kwan | CEO | 3,000,000 |
| Mr. James E. McCarthy | CFO | 2,000,000 |
| Ms. Lisa J. Smith | Board Member | 1,000,000 |
Stock Performance
Elevation Oncology's stock has experienced fluctuations in its market value. The closing price as of September 30, 2024, was $1.75 per share. The company reported a net loss of $34.0 million for the nine months ended September 30, 2024, compared to a net loss of $37.8 million for the same period in 2023.
Recent Financing Activity
In the nine months ended September 30, 2024, Elevation Oncology raised approximately $44.2 million through at-the-market offerings, selling 11,625,295 shares of common stock. The company also has a sales agreement with TD Securities for potential gross proceeds of up to $75.0 million, allowing for additional capital raising opportunities.
Market Capitalization
As of September 30, 2024, the market capitalization of Elevation Oncology is approximately $103.5 million, reflecting its share price and total number of outstanding shares.
Elevation Oncology, Inc. (ELEV) Mission Statement
The mission of Elevation Oncology, Inc. is to develop innovative therapies for patients with cancer, focusing on solid tumors characterized by specific genomic alterations. The company aims to leverage its expertise in antibody-drug conjugates (ADCs) to create targeted treatments that address significant unmet medical needs in oncology.
Financial Overview
As of September 30, 2024, Elevation Oncology reported:
- Net loss for the nine months: $34.0 million
- Net loss for the three months: $12.9 million
- Accumulated deficit: $230.0 million
- Cash, cash equivalents, and marketable securities: $103.1 million
- Weighted average common shares outstanding: 59,108,724
- Net loss per share (basic and diluted): $(0.60)
| Category | Q3 2024 | Q3 2023 | YTD 2024 | YTD 2023 |
|---|---|---|---|---|
| Net Loss | $12.9 million | $10.6 million | $34.0 million | $37.8 million |
| Cash, Cash Equivalents, Marketable Securities | $103.1 million | N/A | N/A | N/A |
| Accumulated Deficit | $230.0 million | N/A | N/A | N/A |
| Weighted Average Common Shares Outstanding | 59,108,724 | 46,842,489 | 56,655,302 | 33,040,434 |
| Net Loss per Share | $(0.60) | $(1.14) | N/A | N/A |
Research and Development Focus
Elevation Oncology's primary research and development efforts are concentrated on:
- EO-3021, a novel ADC targeting Claudin 18.2, currently in Phase 1 clinical trials.
- Seribantumab, with further development contingent on collaboration with partners.
For the nine months ended September 30, 2024, the company reported:
| Research and Development Expense Category | Q3 2024 | Q3 2023 | YTD 2024 | YTD 2023 |
|---|---|---|---|---|
| EO-3021 | $3.1 million | $1.7 million | $9.1 million | $3.3 million |
| Seribantumab | $1.5 million | $3.2 million | $3.6 million | $9.5 million |
| Unallocated and Other R&D Expenses | $2.7 million | $0.6 million | $3.0 million | $1.8 million |
Funding and Capital Resources
As of September 30, 2024, Elevation Oncology's financial position includes:
- Equity Financing: Raised $44.2 million from the sale of 11,625,295 shares through at-the-market offerings.
- Long-term Debt: Total long-term debt of $31.0 million.
- Expected Capital Requirements: The company anticipates needing additional funds to support ongoing clinical trials and development of its pipeline.
Net cash used in operating activities for the nine months ended September 30, 2024, was $26.2 million, compared to $44.0 million for the same period in 2023.
| Cash Flow Data | Q3 2024 | Q3 2023 |
|---|---|---|
| Net Cash Used in Operating Activities | $(26.2 million) | $(44.0 million) |
| Net Cash Provided by Financing Activities | $44.9 million | $48.0 million |
| Net Cash Used in Investing Activities | $(19.8 million) | $5.0 million |
Outlook
Elevation Oncology expects to continue incurring significant losses as it advances its clinical programs and invests in research and development. The company is focused on obtaining regulatory approvals and progressing its product candidates through clinical trials.
How Elevation Oncology, Inc. (ELEV) Works
Company Overview
Elevation Oncology, Inc. is a clinical-stage biotechnology company focused on the development of targeted therapies for patients with cancer. The company's lead product candidate, EO-3021, is an antibody-drug conjugate (ADC) designed to target Claudin 18.2, a protein expressed in several solid tumors.
Financial Performance
For the nine months ended September 30, 2024, Elevation Oncology reported a net loss of $34.0 million, a decrease from a net loss of $37.8 million for the same period in 2023. The weighted average common shares outstanding were 56,655,302 for the nine months ended September 30, 2024, resulting in a net loss per share of $0.60.
Operating Expenses
The total operating expenses for the nine months ended September 30, 2024, were $34.1 million, compared to $37.5 million in 2023. The breakdown is as follows:
| Expense Type | 2024 (in thousands) | 2023 (in thousands) | Change (in thousands) |
|---|---|---|---|
| Research and Development | $21,950 | $20,743 | $1,207 |
| General and Administrative | $12,111 | $11,649 | $462 |
| Restructuring Charges | $0 | $5,107 | ($5,107) |
| Total Operating Expenses | $34,061 | $37,499 | ($3,438) |
Research and Development Expenses
Research and development expenses were $9.4 million for the three months ended September 30, 2024, an increase from $7.4 million for the same period in 2023. The increase is primarily attributed to:
- $2.5 million related to in-licensing certain technology.
- $1.9 million increase in preclinical, clinical, regulatory, and other expenses for EO-3021.
- Partially offset by a $2.4 million decrease in manufacturing costs.
Cash Flow and Liquidity
As of September 30, 2024, Elevation Oncology had cash, cash equivalents, and marketable securities totaling $103.1 million. This amount is projected to support the company's operations into 2026.
For the nine months ended September 30, 2024, the company experienced net cash used in operating activities of $26.2 million. The cash flow from investing activities was a net outflow of $19.8 million, while financing activities provided a net cash inflow of $44.9 million.
Debt and Financing Activities
Elevation Oncology entered into a loan and security agreement with K2 HealthVentures, providing up to $50 million in term loans. The first tranche of $30 million has been funded.
In the nine months ended September 30, 2024, the company sold 11,625,295 shares of common stock under its at-the-market offering facility, generating net proceeds of approximately $44.2 million.
Clinical Development and Pipeline
EO-3021 is currently being evaluated in a Phase 1 clinical trial for patients with advanced solid tumors expressing Claudin 18.2. The drug has received orphan drug designation from the FDA for gastric and pancreatic cancers and Fast Track designation for advanced or metastatic gastric cancer.
Stock Performance
The stock performance of Elevation Oncology has been impacted by its clinical development progress and financial results. As of September 30, 2024, the company had 59,119,055 shares of common stock outstanding, with a reported accumulated deficit of $230.0 million.
Future Funding Requirements
Elevation Oncology anticipates significant increases in operating expenses as it advances clinical trials for EO-3021. Future funding may be sought through additional equity offerings or partnerships.
How Elevation Oncology, Inc. (ELEV) Makes Money
Business Model Overview
Elevation Oncology, Inc. (ELEV) operates as a clinical-stage biotechnology company focused on developing targeted therapies for patients with solid tumors. The company primarily aims to advance its product candidates through clinical trials, particularly EO-3021, which is an antibody-drug conjugate (ADC) targeting Claudin 18.2. As of 2024, ELEV has not yet commercialized any products, and its revenue generation is primarily anticipated through future product sales post-approval.
Revenue Generation Potential
As of September 30, 2024, ELEV reported an accumulated deficit of $230 million, indicating that the company has yet to generate significant revenue from product sales. The potential revenue streams will depend on the successful development and commercialization of EO-3021 and other product candidates. The company has entered into licensing agreements that may involve milestone payments and royalties on future sales, which could contribute to revenue generation.
Financial Performance
For the nine months ended September 30, 2024, ELEV reported a net loss of $34.0 million, compared to a net loss of $37.8 million for the same period in 2023. This decrease in net loss reflects the company's efforts to manage costs while advancing its clinical programs. The operating expenses for 2024 were $34.1 million, down from $37.5 million in 2023.
Research and Development Expenses
Research and development (R&D) expenses are a significant component of ELEV's operational costs. For the nine months ending September 30, 2024, R&D expenses totaled $21.9 million, up from $20.7 million in the previous year. The following table summarizes the R&D expenses by major categories:
| Category | 2024 (Nine months) | 2023 (Nine months) |
|---|---|---|
| EO-3021 | $9.1 million | $3.3 million |
| Seribantumab | $3.6 million | $9.5 million |
| Unallocated and Other R&D Expenses | $3.0 million | $1.8 million |
| Unallocated Personnel Costs | $6.1 million | $6.0 million |
| Total R&D Expenses | $21.9 million | $20.7 million |
Funding and Capital Structure
As of September 30, 2024, ELEV maintained cash, cash equivalents, and marketable securities amounting to $103.1 million, which is projected to fund operations into 2026. The company has financed its operations through various means, including:
- Sales of common stock and warrants
- Debt financing
- Collaboration and licensing agreements
Market Opportunities and Future Plans
Elevation Oncology is focused on advancing its lead product candidate, EO-3021, which has received orphan drug designation from the FDA for gastric cancer and pancreatic cancer. The company has plans to expand its pipeline and could potentially generate revenue through milestone payments from licensing agreements, estimated to reach up to $365.5 million in development and regulatory milestones.
Conclusion on Financial Strategy
While Elevation Oncology has not yet generated revenue from product sales, its financial strategy involves significant investments in R&D to develop its product candidates, with the expectation of future revenue generation through successful commercialization and strategic partnerships.
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Resources:
- Elevation Oncology, Inc. (ELEV) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Elevation Oncology, Inc. (ELEV)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Elevation Oncology, Inc. (ELEV)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.