Elevation Oncology(ELEV) - 2022 Q4 - Annual Report

Part I Business Elevation Oncology is a clinical-stage company strategically focused on its lead antibody-drug conjugate candidate, EO-3021, targeting Claudin 18.2 in solid tumors Overview and Strategy - The company's primary focus is now on advancing its lead product candidate, EO-3021, an ADC targeting Claudin 18.2, with plans to initiate a U.S. Phase 1 clinical trial in the second half of 2023[19][20][24] - In January 2023, the company paused further investment and enrollment for its seribantumab program (anti-HER3 mAb for NRG1 fusion tumors) and will only pursue its development in collaboration with a partner[21] - A key strategy is to expand the pipeline by leveraging partnerships, such as the one with Caris Life Sciences, to identify new cancer targets and in-license or acquire promising assets[22][30] Our Lead Product Candidate: EO-3021 - EO-3021 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 that delivers a clinically validated monomethyl auristatin E (MMAE) cytotoxic payload to cancer cells, causing microtubule disruption and apoptosis[27][29] - The company licensed the exclusive worldwide rights (outside of Greater China) from CSPC in July 2022, and the drug has received orphan drug designation for both gastric and pancreatic cancer from the FDA[20][28] Global Market Opportunity for Claudin 18.2 Targeting | Cancer Type | Total U.S. Incidence (approx.) | Total Worldwide Incidence (approx.) | Claudin 18.2 Expression (approx.) | | :--- | :--- | :--- | :--- | | Gastric & Esophageal | 47,000 | 1,700,000 | 77% | | Pancreatic | 62,000 | 496,000 | 70-80% | | Ovarian | 20,000 | 314,000 | 24% | | Lung | 237,000 | 2,200,000 | 6% | - The company believes an ADC approach could be effective in tumors with both low and high levels of Claudin 18.2 expression, potentially capturing a broader patient population than other therapies[39] Competition - The company faces intense competition from various pharmaceutical and biotechnology companies in the oncology space, many with greater financial resources and more established capabilities[45][47] - Direct competition for EO-3021 comes from other companies developing ADCs targeting Claudin 18.2, including Antengene, Keymed Biosciences, KLUS Pharma, RemeGen, and Bristol Myers Squibb[50] - Further competition exists from other therapeutic modalities targeting Claudin 18.2, such as those being developed by Astellas Pharma, CARsgen Therapeutics, and Zai Lab[50] Licensing, collaboration and asset purchase agreements CSPC License Agreement for EO-3021 (July 2022) | Payment Type | Amount | | :--- | :--- | | Upfront Payment | $27.0 million | | Potential Development & Regulatory Milestones | Up to $148.0 million | | Potential Commercial Milestones | Up to $1.0 billion | | Royalties | Mid-single to low-double digits on net sales | | Sublicense Income Share | A percentage up to an aggregate of $50.0 million | - Under the CSPC agreement, CSPC will supply EO-3021 for clinical trials in the U.S. at no cost until the completion of the first Phase 2 trial[54] - The company has a collaboration with Caris Life Sciences to identify novel cancer targets, with a tiered sharing of proceeds from any resulting commercial transaction[57][58] - The company entered into a loan agreement with K2 HealthVentures (K2HV) in July 2022 for up to $50.0 million in term loans, with an initial tranche of $30.0 million funded at closing[69] Intellectual Property - The company's wholly-owned patent portfolio for seribantumab includes U.S. patents expiring between February 2028 and October 2029[80][81] - An additional patent family has been filed for seribantumab's use in treating NRG1 fusion patients, with any resulting patents set to expire in March 2042[82] Governmental Regulation and Product Approval - Biological products in the U.S. are regulated by the FDA and require an approved Biologics License Application (BLA) for marketing[89] - The FDA offers several programs to expedite development and review, including Fast Track, Priority Review, Breakthrough Therapy, and Accelerated Approval, which may apply to the company's candidates[103][104][105][108] - EO-3021 has been granted Orphan Drug Designation for gastric and pancreatic cancer, providing eligibility for a seven-year marketing exclusivity period in the U.S[20][112] - The Inflation Reduction Act (IRA) allows the U.S. government to negotiate prices for certain drugs under Medicare, which could impact future product pricing[148][297] Risk Factors The company faces substantial risks from its limited operating history, significant net losses, and high dependency on its single lead product candidate, EO-3021 - The company has a limited operating history, has incurred significant operating losses since its 2019 inception ($95.1 million in 2022), and expects to incur continued losses[168][171] - Future success is highly dependent on the lead product candidate, EO-3021, which has not completed clinical development[168][196] - The company relies on third parties, primarily its licensor CSPC in China, for the manufacturing of EO-3021, increasing risks related to supply chain, quality, and geopolitics[174][322] - Substantial additional funding is required to continue operations, as existing cash is expected to fund operations only into Q4 2024[181][183] - The company faces substantial competition from numerous companies developing therapies targeting Claudin 18.2 and other cancer treatments, many with significantly greater resources[174][354][357] Unresolved Staff Comments The company reports that it has no unresolved staff comments from the SEC - None[495] Properties The company is a remote-first organization and does not maintain a corporate headquarters or lease any corporate facilities - The company operates as a remote-first company and does not lease or own any corporate facilities[158] Legal Proceedings As of December 31, 2022, the company is not a party to any material legal proceedings - The company is not currently a party to any legal proceedings that would have a material adverse effect on its business[159][497] Mine Safety Disclosures This item is not applicable to the company - Not applicable[498] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on Nasdaq under "ELEV", and the company has never paid cash dividends and does not plan to in the foreseeable future - Common stock trades on The Nasdaq Stock Market under the symbol "ELEV" since June 25, 2021[499] - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[501] [Reserved] This item is reserved Management's Discussion and Analysis of Financial Condition and Results of Operations The company's net loss increased to $95.1 million in 2022, driven by higher R&D expenses for the EO-3021 license, with existing cash expected to fund operations into Q4 2024 Results of Operations Comparison of Operations (Years Ended Dec 31) | (in thousands) | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $78,717 | $23,595 | $55,122 | | General and administrative | $15,832 | $8,451 | $7,381 | | Total operating expenses | $94,549 | $32,046 | $62,503 | | Net loss | $(95,080) | $(32,039) | $(63,041) | - R&D expenses increased by $55.1 million in 2022, primarily due to the $27.0 million upfront payment for the EO-3021 license and a $20.5 million increase in seribantumab manufacturing[542] - General & Administrative expenses increased by $7.4 million in 2022, mainly due to higher personnel and administrative costs[543] Liquidity and Capital Resources - As of December 31, 2022, the company had $90.3 million in cash, cash equivalents, and marketable securities[525] - Management believes existing cash will fund operating expenses and capital requirements into the fourth quarter of 2024[525][556] Summary of Cash Flows (Years Ended Dec 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Cash used in operating activities | $(85,483) | $(30,167) | | Cash used in investing activities | $(44,398) | $0 | | Cash provided by financing activities | $29,514 | $97,051 | - In July 2022, the company secured a loan agreement with K2HV for up to $50.0 million, drawing an initial tranche of $30.0 million[549] Quantitative and Qualitative Disclosures About Market Risk The company's funds are held with a single financial institution and invested in high-grade U.S. Treasuries, representing minimal credit risk - The company holds its cash and money market funds with a single financial institution and invests in high-grade U.S. Treasuries, representing minimal credit risk[577] Financial Statements and Supplementary Data This section contains the company's audited consolidated financial statements for the fiscal years ended December 31, 2022 and 2021 Consolidated Balance Sheet Data (as of Dec 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $45,917 | $146,284 | | Total current assets | $92,977 | $149,424 | | Total assets | $94,161 | $149,494 | | Total current liabilities | $15,692 | $8,789 | | Total liabilities | $45,129 | $8,797 | | Total stockholders' equity | $49,032 | $140,697 | Consolidated Statement of Operations Data (Years Ended Dec 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Research and development | $78,717 | $23,595 | | General and administrative | $15,832 | $8,451 | | Loss from operations | $(94,549) | $(32,046) | | Net loss | $(95,080) | $(32,039) | | Net loss per share | $(4.09) | $(2.64) | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[707] Controls and Procedures Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[708] - Based on the COSO 2013 framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[713] - No material changes occurred in the company's internal control over financial reporting during the fourth quarter of 2022[715] Other Information The company reports no other information for this item - None[716] Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - None[717] Part III Directors, Executive Officers and Corporate Governance Required information will be incorporated by reference from the company's 2023 Annual Meeting of Stockholders proxy statement - Information is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[719] Executive Compensation Required information regarding executive compensation will be incorporated by reference from the company's 2023 proxy statement - Information is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[721] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Required information on security ownership will be incorporated by reference from the company's 2023 proxy statement - Information is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[722] Certain Relationships and Related Transactions, and Director Independence Required information on related transactions and director independence will be incorporated by reference from the company's 2023 proxy statement - Information is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[723] Principal Accountant's Fees and Services Required information on accountant fees and services will be incorporated by reference from the company's 2023 proxy statement - Information is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[724] Part IV Exhibits and Financial Statement Schedules This section lists the exhibits filed as part of the Annual Report, noting that all financial statement schedules have been omitted - This section provides an index of all exhibits filed with the Form 10-K[727] - All financial statement schedules have been omitted because they are not applicable or the information is already present in the financial statements[726] Form 10-K Summary The company provides no summary for Form 10-K - None[732]