UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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Item 2.02. Results of Operations and Financial Condition.
On May 15, 2023, Elevation Oncology, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this report.
The information in this Item 2.02, including Exhibit 99.1 to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) | Exhibits |
Exhibit |
| Description of Document |
99.1 | ||
104 | Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Elevation Oncology, Inc. | |||
Date: May 15, 2023 | By: | /s/ Joseph J. Ferra, Jr. | |
Joseph J. Ferra, Jr. | |||
Interim Chief Executive Officer and President, and Chief Financial Officer | |||
2
Elevation Oncology Reports First Quarter 2023 Financial Results and Highlights Recent Business Achievements
| ● | Partner CSPC Pharmaceutical Group Limited’s ongoing Phase 1 SYSA1801 (EO-3021) clinical trial data selected for poster presentation and poster discussion at ASCO 2023 |
| ● | Presented EO-3021 preclinical proof-of-concept data at AACR 2023 which demonstrated anti-tumor activity in models expressing varying levels of Claudin 18.2; clinical case study highlighted SYSA1801 (EO-3021) induced a confirmed partial response in a patient with metastatic gastric cancer |
NEW YORK, May 15, 2023 -- 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 financial results for the quarter ended March 31, 2023, and highlighted recent business achievements.
“Throughout the first quarter of 2023, we made significant progress as a company. Most recently, we presented preclinical data for our lead candidate, EO-3021, demonstrating anti-tumor activity in preclinical models expressing varying levels of Claudin 18.2, and highlighted a clinical case study showing EO-3021 induced a confirmed partial response in a patient with metastatic gastric cancer,” said Joseph Ferra, Interim Chief Executive Officer of Elevation Oncology. “This is an exciting time for us as we and our partner, CSPC Pharmaceutical Group Limited, embark on sharing initial clinical data from the ongoing Phase 1 study of EO-3021 at ASCO 2023. In addition, we remain on track to initiate our Phase 1 trial evaluating EO-3021 in the US in the second half of 2023.”
Recent Business Achievements
EO-3021
| ● | Presented preclinical proof-of-concept data at AACR 2023. Key preclinical findings included demonstrating anti-tumor activity in preclinical xenograft models of pancreatic and gastric cancers expressing varying levels of Claudin 18.2. A single-dose of EO-3021 demonstrated tumor regression across low, medium, and high Claudin 18.2-expressing models, with a lower minimal efficacious dose in models with medium and high levels of Claudin 18.2 relative to models with low levels of Claudin 18.2. EO-3021 also outperformed standard of care chemotherapy in gastric and pancreatic cancer preclinical xenograft models. |
| ● | Highlighted clinical case study of EO-3021 at AACR 2023. A clinical case study of a patient with metastatic gastric cancer in an ongoing Phase 1 clinical trial of SYSA1801 (EO-3021) in China (NCT05009966) conducted by CSPC Pharmaceutical Group Limited (HKEX: 01093) was also highlighted. The patient was treated with dose level 2, or 1.0mg/kg EO-3021, intravenously, every three weeks (treatment ongoing). The best overall response, as evaluated per RECIST v1.1, was a confirmed partial response (66.7% maximal tumor reduction), while the duration of response was approximately 11 months and ongoing. |
| ● | SYSA1801 (EO-3021) Phase 1 data selected for presentation at ASCO 2023. An abstract featuring SYSA1801 (EO-3021) Phase 1 clinical data has been selected for a poster presentation and poster discussion at the upcoming American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, being held June 2-6, 2023, in Chicago, IL. The ongoing Phase 1 dose escalation and dose expansion study is evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors and is being conducted in China by Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093). |
Other Pipeline Programs
| ● | Continue research and development efforts to advance novel therapeutic drug candidates and targets. Additional pipeline programs include those through its existing partnership with Caris Life Sciences. |
Expected Upcoming Milestones and Operational Objectives
| ● | Initiate Phase 1 clinical trial of EO-3021 in the US in the second half of 2023 |
| ● | Ongoing target evaluation for future pipeline expansion |
First Quarter 2023 Financial Results
As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $73.9 million, compared to $90.3 million as of December 31, 2022.
Research and development expenses for the first quarter 2023 were $7.3 million, compared to $13.6 million for the first quarter 2022. The decrease in R&D expense in the first quarter of 2023 was primarily related to the decrease in costs related to manufacturing clinical supply of seribantumab for use in the CRESTONE clinical trial. The Company prioritized its pipeline and realigned resources to advance its EO-3021 product candidate.
General and administrative expenses for the first quarter 2023 were $4.3 million, compared to $3.8 million for the first quarter 2022. The increase in G&A expense in the first quarter of 2023 was primarily related to increases in personnel costs, professional services and other administrative costs.
Restructuring charges were $5.1 million for the first quarter 2023, and consisted primarily of one-time charges related to the pipeline prioritization and realignment of resources to advance our EO-3021 product candidate, including $1.6 million of termination and contractual termination benefits for severance, healthcare and related benefits.
Net loss for the first quarter 2023 was $17.1 million, compared to $17.3 million for the first quarter 2022.
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is only expressed in gastric epithelial cells. During malignant transformation of gastric cancer, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Claudin 18.2 can also be expressed in other solids tumors. An Investigational New Drug application for EO-3021 has been cleared by the U.S. Food and Drug Administration.
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 rethinking drug development by seeking out innovative, selective cancer therapies that can be matched to a patient's unique tumor characteristics. Our lead candidate, EO-3021, is a potential best-in-class antibody drug conjugate (ADC) designed to target Claudin 18.2, a clinically validated molecular target. EO-3021 selectively delivers a cytotoxic payload directly to cancer cells expressing Claudin 18.2. We are working to rapidly advance EO-3021 into the clinic in the US across a range of solid tumor indications, as well as exploring other opportunities through new or existing partnerships and business development opportunities to expand our novel oncology pipeline. 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 preclinical and clinical development activities, expected timing of announcements of clinical results, 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," "potential," "possible," "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, the impact of the continued presence of COVID-19 on Elevation Oncology's business, 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)
|
| Three months ended March 31, | ||||
|
| 2023 |
| 2022 | ||
Operating expenses: |
| |
|
| |
|
Research and development | | $ | 7,292 | | $ | 13,575 |
General and administrative | |
| 4,346 | |
| 3,793 |
Restructuring charges | | | 5,107 | | | — |
Total operating expenses | |
| 16,745 | |
| 17,368 |
Loss from operations | |
| (16,745) | |
| (17,368) |
Other income (expense), net | |
| (309) | |
| 93 |
Loss before income taxes | | | (17,054) | | | (17,275) |
Income tax expense | | | 5 | | | — |
Net loss | | $ | (17,059) | | $ | (17,275) |
Net loss per share, basic and diluted | | $ | (0.72) | | $ | (0.74) |
Weighted average common shares outstanding, basic and diluted | |
| 23,618,559 | |
| 23,216,206 |
| | | | | | |
Comprehensive loss: | | | | | | |
Net loss | | $ | (17,059) | | $ | (17,275) |
Other comprehensive gain (loss): | | | | | | |
Unrealized gain (loss) on marketable securities | | | 110 | | | (204) |
Total other comprehensive gain (loss) | | $ | 110 | | $ | (204) |
Total comprehensive loss | | $ | (16,949) | | $ | (17,479) |
Selected Financial Information
(In thousands, except share and per share data)
(unaudited)
| | March 31, | | December 31, |
Selected Balance Sheet items (in thousands): |
| 2023 |
| 2022 |
Cash, cash equivalents and marketable securities | | $ 73,929 | | $ 90,280 |
Prepaid expenses and other current assets | | 1,906 | | 2,697 |
Working Capital1 | | 62,301 | | 77,285 |
Total Assets | | 76,898 | | 94,161 |
Long-term debt, net of discount | | 29,600 | | 29,435 |
Total Stockholders' Equity | | 33,764 | | 49,032 |
1 We define working capital as current assets less current liabilities.
Document and Entity Information |
May 15, 2023 |
|---|---|
| Document and Entity Information [Abstract] | |
| Document Type | 8-K |
| Written Communications | false |
| Document Period End Date | May 15, 2023 |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Entity Registrant Name | Elevation Oncology, Inc. |
| Entity File Number | 001-40523 |
| Entity Incorporation, State or Country Code | DE |
| Entity Tax Identification Number | 84-1771427 |
| Entity Address, Address Line One | 888 Seventh Ave. |
| Entity Address, Adress Line Two | 12th Floor |
| Entity Address, City or Town | New York |
| Entity Address State Or Province | NY |
| Entity Address, Postal Zip Code | 10106 |
| City Area Code | 716 |
| Local Phone Number | 371-1125 |
| Title of 12(b) Security | Common stock, par value $0.0001 per share |
| Trading Symbol | ELEV |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Entity Ex Transition Period | false |
| Entity Central Index Key | 0001783032 |
| Amendment Flag | false |