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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 2, 2023

Elevation Oncology, Inc.

(Exact name of Registrant as Specified in its Charter)

Delaware

001-40523

84-1771427

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

101 Federal Street, Suite 1900

Boston, Massachusetts

02110

(Address of Principal Executive Offices)

(Zip Code)

(716) 371-1125

Registrant’s Telephone Number, Including Area Code

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.0001 per share

ELEV

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Item 2.02.

Results of Operations and Financial Condition.

On November 2, 2023 Elevation Oncology, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2023. A copy of the press release is attached as Exhibit 99.1 to this report.

The information furnished in this Item 2.02, including Exhibit 99.1, shall not be deemed “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, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

Item 9.01.

Financial Statements and Exhibits.

(d)

Exhibits

Exhibit 

Number

Description

99.1

104

Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101).

1

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: November 2, 2023

By: /s/ Tammy Furlong

Tammy Furlong

Chief Financial Officer

2

Exhibit 99.1

Elevation Oncology Reports Third Quarter 2023 Financial Results and Highlights Recent Business Achievements

-- Enrollment is ongoing in the Phase 1 clinical trial evaluating EO-3021 in patients with advanced solid tumors likely to express Claudin 18.2; preliminary safety and anti-tumor activity data expected in 1H 2025 --

Boston, Mass. November 2, 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 third quarter ended September 30, 2023, and highlighted recent business achievements.

“In the third quarter, we achieved a key milestone in our efforts to establish EO-3021 as a potential best-in-class anti-Claudin 18.2 ADC therapy, initiating patient enrollment in our Phase 1 clinical trial,” said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. “Claudin 18.2 is a validated target, expressed at varying levels in solid tumor types that affect millions of patients globally. As an ADC, EO-3021 is uniquely positioned to address a broad population by targeting tumors that express varying levels of Claudin 18.2, which may be inaccessible to other therapeutic approaches, while also potentially delivering improved efficacy and tolerability. As demonstrated by initial clinical data from our partner in China, we believe EO-3021 could deliver an important treatment option for patients.”

Recent Business Achievements

In August 2023, Elevation Oncology began enrolling patients in its Phase 1 clinical trial of EO-3021 (NCT05980416). The Phase 1 clinical trial is an open-label, multi-center, dose escalation and expansion study designed to evaluate the safety, tolerability and preliminary anti-tumor activity of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers. An additional objective of the study is to assess the association of Claudin 18.2 expression and objective response. Elevation Oncology expects to report preliminary safety and anti-tumor activity data during the first half of 2025.

Third Quarter 2023 Financial Results

As of September 30, 2023, Elevation Oncology had cash, cash equivalents and marketable securities totaling $94.8 million, compared to $90.3 million as of December 31, 2022. The increase in cash reflects net proceeds of approximately $46.5 million from Elevation Oncology’s underwritten public offering, which closed in June 2023, partially offset by cash used to fund operating activities.

Research and development (R&D) expenses for the third quarter 2023 were $7.4 million, compared to $34.3 million for the third quarter 2022. The decrease in R&D expenses in the third quarter of 2023 was primarily due to the cost related to the license agreement between Elevation Oncology and a subsidiary of CSPC Pharmaceutical Group Limited for rights to develop and commercialize EO-3021, which was recorded in the third quarter of 2022.

General and administrative (G&A) expenses for the third quarter 2023 were $3.5 million, compared to $4.2 million for the third quarter 2022. The decrease in G&A expenses in the third quarter of 2023 was primarily due to a decrease in administrative costs, including directors’ and officers’ insurance.

Net loss for the third quarter 2023 was $10.6 million, compared to $38.8 million for the third quarter 2022.


Financial Outlook

Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of September 30, 2023, to be sufficient to fund its current operations into the second half of 2025.

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. EO-3021is 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 normally expressed in gastric epithelial cells. During malignant transformations, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 study (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.

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 evaluating EO-3021 in a Phase 1 study in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal, pancreatic or esophageal cancers. We are also exploring other opportunities through new or existing partnerships and business development opportunities to expand our 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 clinical development activities, potential benefits of Elevation Oncology’s product candidates, potential market opportunities for Elevation Oncology’s product candidates, and the ability of Elevation Oncology’s product candidates to treat their targeted indications. 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

Results of Operations (unaudited)

    

Three months ended September 30, 

(In thousands, except share and per-share amounts)

    

2023

    

2022

Operating expenses:

    

  

    

  

Research and development

$

7,422

$

34,340

General and administrative

 

3,498

 

4,191

Total operating expenses

 

10,920

 

38,531

Loss from operations

 

(10,920)

 

(38,531)

Other income (expense), net

 

295

 

(306)

Loss before income taxes

(10,625)

(38,837)

Income tax expense

11

Net loss

(10,636)

(38,837)

Net loss per share, basic and diluted

$

(0.25)

$

(1.67)

Weighted average common shares outstanding, basic and diluted

 

42,402,489

 

23,290,249


Selected Financial Information

Consolidated Balance Sheets (unaudited)

September 30, 

December 31, 

(in thousands):

2023

2022

Cash, cash equivalents and marketable securities

$ 94,797

$ 90,280

Prepaid expenses and other current assets

4,000

2,697

Working Capital1

91,190

77,285

Total Assets

99,975

94,161

Long-term debt, net of discount

29,952

29,435

Total Stockholders' Equity

62,416

49,032

1 We define working capital as current assets less current liabilities.


v3.23.3
Document and Entity Information
Nov. 02, 2023
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Nov. 02, 2023
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 101 Federal Street
Entity Address, Address Line Two Suite 1900
Entity Address, City or Town Boston
Entity Address State Or Province MA
Entity Address, Postal Zip Code 02110
City Area Code 716
Local Phone Number 371-1125
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
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

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