Group 1 - Halper Sadeh LLC is investigating potential violations of federal securities laws and breaches of fiduciary duties related to the sale of Know Labs, Inc. to Goldeneye 1995 LLC [1] - Elevation Oncology, Inc. is set to be sold to Concentra Biosciences, LLC, with shareholders receiving $0.36 in cash per share and contingent value rights based on future net cash and proceeds from EO-1022 [1] - Crown Electrokinetics Corp. is being sold to Crown EK Acquisition LLC for $3.15 per share [2] Group 2 - Halper Sadeh LLC may seek increased consideration for shareholders and additional disclosures regarding the proposed transactions [3] - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options at no charge [4] - The firm represents investors globally who have experienced securities fraud and corporate misconduct, recovering millions for defrauded investors [4]

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Elevation Oncology's beliefs and expectations and statements about the Offer, the merger and related transactions contemplated by the Merger Agreement and the CVR Agreement (the "Transactions"), the ability to complete the transactions contemplated by the Merger Agreement, including the ability to satisfy the conditions to th ...

[Highlights](index=1&type=section&id=Highlights) Elevation Oncology reported Q1 2025 results, highlighting positive preclinical data for its HER3 ADC, EO-1022, with an IND filing expected in 2026, alongside exploring strategic alternatives and projecting a cash runway into the second half of 2026 after program discontinuation - Presented promising preclinical proof-of-concept data for its potentially differentiated **HER3 ADC, EO-1022**, at the AACR Annual Meeting[1](index=1&type=chunk)[2](index=2&type=chunk)[5](index=5&type=chunk) - Expects to file an **Investigational New Drug (IND) application for EO-1022 in 2026**[1](index=1&type=chunk)[3](index=3&type=chunk) - The company is exploring a range of **strategic alternatives** to maximize shareholder value[2](index=2&type=chunk)[4](index=4&type=chunk) - **Cash runway** is expected to fund operations into the **second half of 2026**[1](index=1&type=chunk)[7](index=7&type=chunk) [Business and Pipeline Updates](index=1&type=section&id=Recent%20Business%20Updates) The company strategically shifted its focus to developing the HER3 ADC, EO-1022, after discontinuing the EO-3021 program and reducing its workforce by 70%, with preclinical data for EO-1022 suggesting improved safety and potent anti-tumor activity - In March 2025, the company **discontinued the development of EO-3021** and implemented an associated **workforce reduction of approximately 70%**[4](index=4&type=chunk) - The primary pipeline focus is now on **EO-1022, a HER3 ADC for solid tumors**, with an **IND filing planned for 2026**[3](index=3&type=chunk)[11](index=11&type=chunk) - Preclinical data for EO-1022 showed **high stability**, a **homogenous drug-to-antibody ratio (DAR) of 4**, and **minimal free payload**, suggesting a potential for **reduced toxicity** and an **improved safety profile**[5](index=5&type=chunk) - EO-1022 demonstrated **potent anti-tumor activity** in in-vivo models with varying HER3 expression levels, including low-expressing cancer models[5](index=5&type=chunk) [Financial Results and Outlook](index=2&type=section&id=Financial%20Results%20and%20Outlook) Elevation Oncology reported a Q1 2025 net loss of $14.2 million, up from $10.7 million in Q1 2024 due to restructuring charges, and projects a cash balance of $30-$35 million by Q2 2025, sufficient to fund operations into the second half of 2026 [Financial Performance (Q1 2025)](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) For Q1 2025, the company's net loss widened to $14.2 million ($0.24 per share) from $10.7 million ($0.21 per share) in Q1 2024, primarily due to increased R&D expenses for EO-1022 and $3.4 million in restructuring charges | Metric | Q1 2025 ($ thousands) | Q1 2024 ($ thousands) | Change | | :--- | :--- | :--- | :--- | | Research and development | 6,876 | 6,011 | +$865k | | General and administrative | 3,965 | 3,858 | +$107k | | Restructuring charges | 3,375 | — | +$3,375k | | **Total operating expenses** | **14,216** | **9,869** | **+$4,347k** | | **Net loss** | **(14,211)** | **(10,707)** | **Worsened** | | **Net loss per share** | **(0.24)** | **(0.21)** | **Worsened** | - The **$0.9 million increase in R&D expenses** was primarily due to a **$1.3 million increase** in costs for the preclinical development of EO-1022[8](index=8&type=chunk) - The company incurred **$3.4 million in restructuring charges** related to the workforce reduction and discontinuation of the EO-3021 program[10](index=10&type=chunk) [Financial Position and Outlook](index=2&type=section&id=Financial%20Outlook) As of March 31, 2025, Elevation Oncology held $80.7 million in cash and equivalents, and after a $32.3 million loan prepayment, projects a cash balance of $30-$35 million by June 30, 2025, expected to fund operations into the second half of 2026 | Selected Balance Sheet Data ($ thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | 80,659 | 93,184 | | Total assets | 82,223 | 95,626 | | Total stockholders' equity | 46,734 | 60,025 | - On May 2, 2025, the company voluntarily prepaid its **$32.3 million loan** (including principal, interest, fees, and expenses) with K2 HealthVentures[6](index=6&type=chunk) - The company projects its cash, cash equivalents, and marketable securities to be between **$30 million and $35 million** as of June 30, 2025[7](index=7&type=chunk) - The current cash position is expected to fund operations into the **second half of 2026**[7](index=7&type=chunk) [About Elevation Oncology & EO-1022](index=2&type=section&id=About%20Elevation%20Oncology%2C%20Inc.) Elevation Oncology is a clinical-stage company developing selective cancer therapies, with its lead candidate EO-1022, a next-generation HER3-targeting antibody-drug conjugate (ADC) constructed for enhanced efficacy and safety - EO-1022 is an ADC composed of the fully human IgG2 anti-HER3 antibody seribantumab, site-specifically conjugated to the MMAE payload with a **drug-to-antibody ratio (DAR) of 4**[11](index=11&type=chunk) - The company is leveraging its ADC expertise to develop therapies for solid tumors with significant unmet medical needs, with an **IND for EO-1022 expected in 2026**[12](index=12&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section contains standard "safe harbor" provisions, cautioning that statements regarding future events, including clinical development, regulatory submissions, cash runway, and strategic options, are subject to risks and uncertainties and are not guarantees of future performance - The press release includes **forward-looking statements** concerning clinical development activities, regulatory submission timing, potential benefits of product candidates, and the company's cash runway[13](index=13&type=chunk) - These statements are subject to **significant risks and uncertainties**, and actual results may differ materially from expectations, as detailed in SEC filings under "Risk Factors"[14](index=14&type=chunk)

Core Insights - Elevation Oncology presented preclinical data for EO-1022, a HER3 antibody-drug conjugate (ADC), at the AACR Annual Meeting, indicating its potential as a differentiated treatment option for HER3-expressing solid tumors [1][2][7] - The company plans to file an Investigational New Drug (IND) application for EO-1022 in 2026 [1][3][11] - Elevation Oncology has a cash runway expected to last into the second half of 2026, with an estimated cash balance of $30 million to $35 million by June 30, 2025 [5][6] Recent Business Updates - The company is focusing on EO-1022 for treating HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer [3][11] - In March 2025, Elevation Oncology discontinued the development of EO-3021 and reduced its workforce by approximately 70% [4] - The company is exploring strategic alternatives to maximize shareholder value, with no set timetable for completion of this review [4][2] Financial Outlook - As of March 31, 2025, Elevation Oncology reported $80.7 million in cash, cash equivalents, and marketable securities [5][14] - Research and development expenses for Q1 2025 were $6.9 million, an increase from $6.0 million in Q1 2024, primarily due to costs associated with EO-1022 [8][14] - The net loss for Q1 2025 was $14.2 million, compared to a net loss of $10.7 million in Q1 2024 [10][14]

Part I Financial Information [Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, reflecting a net loss of **$14.2 million** and a strategic shift to EO-1022 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$82.2 million** as of March 31, 2025, primarily due to reduced marketable securities, while total stockholders' equity declined to **$46.7 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $60,494 | $49,464 | | Marketable securities, available for sale | $20,165 | $43,720 | | **Total current assets** | **$82,194** | **$94,726** | | **Total assets** | **$82,223** | **$95,626** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $4,236 | $4,467 | | Long-term debt, net of discount | $31,253 | $31,134 | | **Total liabilities** | **$35,489** | **$35,601** | | **Total stockholders' equity** | **$46,734** | **$60,025** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to **$14.2 million** for the three months ended March 31, 2025, primarily due to **$3.4 million** in restructuring charges Statement of Operations Summary (in thousands, except per share data) | Metric | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $6,876 | $6,011 | | General and administrative | $3,965 | $3,858 | | Restructuring charges | $3,375 | $0 | | **Total operating expenses** | **$14,216** | **$9,869** | | Loss from operations | ($14,216) | ($9,869) | | **Net loss** | **($14,211)** | **($10,707)** | | Net loss per share, basic and diluted | ($0.24) | ($0.21) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$12.7 million**, while investing activities provided **$23.8 million**, leading to an **$11.0 million** increase in cash and equivalents Cash Flow Summary (in thousands) | Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,711) | ($9,575) | | Net cash provided by investing activities | $23,758 | $20,700 | | Net cash (used in) provided by financing activities | ($17) | $30,250 | | **Increase in cash and cash equivalents** | **$11,030** | **$41,375** | | **Cash and cash equivalents, end of period** | **$60,494** | **$90,630** | [Notes to Condensed Consolidated Financial Statements (unaudited)](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Notes detail the strategic shift to EO-1022, discontinuation of EO-3021, a **70%** workforce reduction, **$3.4 million** in restructuring charges, and debt prepayment - In March 2025, the company discontinued development of EO-3021 (a Claudin 18.2 ADC) and initiated a process to evaluate strategic options. The company is now focusing on advancing EO-1022, a HER3-targeting ADC[20](index=20&type=chunk) - The company believes its cash, cash equivalents, and marketable securities of **$80.7 million** as of March 31, 2025, are sufficient to fund operations through at least 12 months from the financial statement issuance date[23](index=23&type=chunk) - In connection with discontinuing EO-3021, the company implemented a **70%** workforce reduction and incurred **$3.4 million** in restructuring charges, including **$2.2 million** for severance and benefits and **$1.2 million** in asset write-offs[55](index=55&type=chunk)[56](index=56&type=chunk) - In May 2025, the company voluntarily prepaid its **$32.3 million** Term Loan with K2HV in full, satisfying all obligations under the Loan Agreement[117](index=117&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to focus on EO-1022, the discontinuation of EO-3021, a **70%** workforce reduction, and the **$14.2 million** net loss for Q1 2025 - The company is leveraging its ADC expertise to advance EO-1022, a potentially differentiated HER3 ADC, and expects to file an IND application in 2026[120](index=120&type=chunk)[121](index=121&type=chunk) - In March 2025, the company discontinued development of the Claudin 18.2 ADC, EO-3021, based on data from its Phase 1 trial, which showed an objective response rate of **22.2%**[123](index=123&type=chunk)[125](index=125&type=chunk) - The company implemented a workforce reduction of approximately **70%** in March 2025, resulting in restructuring charges of **$3.4 million** in the first quarter[129](index=129&type=chunk)[148](index=148&type=chunk) Results of Operations Comparison (in thousands) | | Three months ended March 31, | | | :--- | :--- | :--- | | | 2025 | 2024 | | **Research and development** | $6,876 | $6,011 | | **General and administrative** | $3,965 | $3,858 | | **Restructuring charges** | $3,375 | $0 | | **Net loss** | $(14,211) | $(10,707) | - As of March 31, 2025, the company had **$80.7 million** in cash, cash equivalents, and marketable securities, which is expected to fund operations into the second half of 2026[159](index=159&type=chunk)[168](index=168&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=58&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$80.7 million** in cash, cash equivalents, and marketable securities, with no significant foreign currency risk - The company's primary market risk is interest rate sensitivity on its **$80.7 million** in cash, cash equivalents, and marketable securities[184](index=184&type=chunk) - The company is not currently exposed to significant risk from foreign currency exchange rates[185](index=185&type=chunk) [Controls and Procedures](index=58&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Based on an evaluation as of March 31, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[186](index=186&type=chunk) - No changes in internal control over financial reporting occurred during the three months ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[188](index=188&type=chunk) Part II Other Information [Legal Proceedings](index=61&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no involvement in any legal proceedings - The company reports no legal proceedings[191](index=191&type=chunk) [Risk Factors](index=61&type=section&id=Item%201A.%20Risk%20Factors) Key risks include strategic review uncertainty, limited operating history with significant losses, high dependency on EO-1022, need for additional funding, and potential Nasdaq delisting - The company has initiated a process to evaluate strategic options, but there is no assurance that this will result in a suitable transaction or that it will be completed on attractive terms[194](index=194&type=chunk)[195](index=195&type=chunk) - The company has a limited operating history, has incurred significant losses since inception (accumulated deficit of **$254.7 million** as of March 31, 2025), and expects to incur continued losses[197](index=197&type=chunk) - Future success is highly dependent on a single product candidate, EO-1022, which has not completed clinical development or obtained regulatory approval[215](index=215&type=chunk) - The company relies on third parties, some based in China, to manufacture clinical supplies, which increases risks related to supply chain, cost, quality, and geopolitical tensions[332](index=332&type=chunk)[333](index=333&type=chunk)[334](index=334&type=chunk) - The company's common stock does not meet the Nasdaq minimum bid price requirement. It has until September 15, 2025, to regain compliance or face delisting[488](index=488&type=chunk)[489](index=489&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=173&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds from public offerings during the period - There were no unregistered sales of equity securities in the period[499](index=499&type=chunk) [Defaults Upon Senior Securities](index=173&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon its senior securities - There were no defaults upon senior securities[501](index=501&type=chunk) [Mine Safety Disclosures](index=174&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[502](index=502&type=chunk) [Other Information](index=174&type=section&id=Item%205.%20Other%20Information) The company did not report any other information under this item - None[503](index=503&type=chunk) [Exhibits](index=174&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including a separation agreement and SOX certifications by the Principal Executive and Financial Officers - The report includes as exhibits the CEO and CFO certifications required under Sections 302 and 906 of the Sarbanes-Oxley Act[506](index=506&type=chunk) - A separation agreement dated March 31, 2025, with Valerie Malyvanh Jansen was filed as Exhibit 10.1[506](index=506&type=chunk)

Core Insights - Elevation Oncology is advancing EO-1022, a differentiated HER3 antibody-drug conjugate (ADC) aimed at addressing unmet medical needs in various solid tumors, with an IND application expected in 2026 [1][4][6] Group 1: Product Development - EO-1022 is designed with features such as glycan site-specific conjugation and MMAE payloads, which may enhance efficacy and safety for patients with solid tumors [2] - The ADC consists of seribantumab, a fully human IgG2 anti-HER3 monoclonal antibody, conjugated to the MMAE payload with a drug-to-antibody ratio (DAR) of 4 [2][4] - Preclinical data indicate that EO-1022 shows enhanced stability and anti-tumor activity compared to benchmark HER3 ADCs in both in vitro and in vivo models [2][5] Group 2: Clinical Potential - EO-1022 demonstrates potent in vitro cytotoxicity that is dependent on HER3 expression levels and elicits anti-tumor activity across various HER3 expression levels in vivo [5] - The ADC is being developed for HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer [4][6] Group 3: Company Overview - Elevation Oncology focuses on the discovery and development of selective cancer therapies to meet significant unmet medical needs in oncology [5][6] - The company leverages its expertise in ADC technology to advance EO-1022, which is currently in preclinical development [5][6]

Core Insights - Elevation Oncology is developing EO-1022, a differentiated HER3 antibody-drug conjugate (ADC) aimed at treating solid tumors, including breast cancer and non-small cell lung cancer, with an Investigational New Drug (IND) application expected to be filed in 2026 [1][5][6] Company Overview - Elevation Oncology focuses on discovering and developing selective cancer therapies for patients with significant unmet medical needs [6] - The company is leveraging advanced site-specific conjugation technology licensed from Synaffix B.V. to enhance the efficacy of EO-1022 [2][5] Product Details - EO-1022 consists of seribantumab, a fully human IgG2 anti-HER3 monoclonal antibody, conjugated to the monomethyl auristatin E (MMAE) payload with a drug-to-antibody ratio (DAR) of 4 [2][5] - The ADC is designed to target HER3-expressing solid tumors, providing a potential new treatment option for patients who are refractory to existing HER3-targeting agents [3][5] Upcoming Presentation - Preclinical data for EO-1022 will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, scheduled for April 25-30 in Chicago, Illinois [1][4] - The late-breaking abstract will be available on the AACR website starting April 25, 2025 [4][8]

Core Viewpoint - Elevation Oncology's shares dropped over 40% following disappointing phase I study results for its lead drug EO-3021, which showed an objective response rate of only 22.2% in patients with advanced gastric and gastroesophageal junction cancers [1][2]. Company Developments - Following the poor study results, Elevation Oncology has decided to halt further clinical development of EO-3021 and will focus on a new solid tumor candidate, EO-1022, with an IND filing expected next year [2]. - The company is now without any pipeline candidates in clinical development, contributing to the significant decline in share price [2]. - Elevation Oncology plans to reduce its workforce by 70% as part of a restructuring effort to cut costs, which includes the departure of its Chief Medical Officer [5]. - The restructuring is expected to incur around $3 million in costs, primarily by the end of June [6]. Financial Performance - Year-to-date, Elevation Oncology's shares have decreased nearly 51%, contrasting with a 7% growth in the industry [3]. - The company has a cash balance of approximately $93 million as of the end of 2024, which is projected to last into the second half of 2026 following the restructuring [5].

Core Viewpoint - Elevation Oncology has decided to discontinue the development of EO-3021, an antibody-drug conjugate for treating advanced gastric and gastroesophageal junction cancers, due to disappointing trial data [1][3]. Group 1: Clinical Trial Results - EO-3021 as a monotherapy showed an objective response rate of 22.2%, with 1 confirmed complete response and 7 confirmed partial responses among 36 evaluable patients [2]. - The disease control rate for EO-3021 was reported at 72.2% for patients with Claudin 18.2 expression in ≥20% of tumor cells [2]. - Despite being generally well-tolerated in a safety analysis of 85 enrolled patients, EO-3021 did not meet the company's success criteria [3]. Group 2: Strategic Decisions - The company will continue to develop EO-1022, a HER3 ADC for patients with HER3-expressing solid tumors, with plans to file an Investigational New Drug (IND) application in 2026 [3]. - Elevation Oncology is evaluating strategic options to maximize shareholder value and is implementing a workforce reduction of approximately 70%, resulting in costs of about $3 million [4]. Group 3: Financial Position - As of December 31, Elevation Oncology reported cash, cash equivalents, and marketable securities totaling $93.2 million, which is expected to fund operations into the second half of 2026 [5]. - Following the announcement, ELEV stock experienced a decline of 47.1%, trading at 25 cents [5].

Core Insights - Elevation Oncology has decided to discontinue the development of EO-3021, a Claudin 18.2 ADC, due to insufficient efficacy data despite a reasonable safety profile [1][3] - The company will continue to advance EO-1022, a HER3 ADC, with plans to present preclinical data at the AACR Annual Meeting in 2025 and file an IND application in 2026 [1][7] - A workforce reduction of approximately 70% is being implemented, with estimated costs of around $3 million associated with this restructuring [4][6] Development Updates - EO-3021 demonstrated an objective response rate (ORR) of 22.2% and a disease control rate (DCR) of 72.2% in a Phase 1 trial involving 36 evaluable patients [2] - The safety profile of EO-3021 was generally well-tolerated, with minimal hematological toxicity and no peripheral neuropathy observed [2] Financial Position - As of December 31, 2024, Elevation Oncology reported cash, cash equivalents, and marketable securities totaling $93.2 million, which is expected to fund operations into the second half of 2026 [6]