0001783032false00017830322024-03-062024-03-06

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): March 6, 2024

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 March 6, 2024, Elevation Oncology, Inc. issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 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: March 6, 2024

By: /s/ Tammy Furlong

Tammy Furlong

Chief Financial Officer

2

Exhibit 99.1

Elevation Oncology Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Achievements

--Expanded ongoing Phase 1 clinical trial of EO-3021 globally, dosing first patient in Japan; on track to provide update in mid-2024 and to report additional data in 1H 2025 --

-- Preclinical proof-of-concept data for HER3-ADC program to be presented at AACR Annual Meeting; plan to nominate development candidate in 2024 –

-- Raised approximately $17.0M in net proceeds through at-the-market (ATM) facility and refinanced debt facility with K2 Health Ventures; cash runway into the fourth quarter of 2025 --

Boston, Mass. March 6, 2024 – 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 and full-year ended December 31, 2023, and highlighted recent business achievements.

“We are entering 2024 with tremendous momentum across our pipeline of differentiated ADC therapies,” said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. “We continue to advance EO-3021 and remain on-track to share an update from our Phase 1 clinical trial mid-year, as well as details on our combination strategy in the months ahead. In addition, we recently expanded our Phase 1 clinical trial into Japan, a geography with a particularly high prevalence of gastric cancer. This will allow us to potentially address a significant unmet need for new gastric cancer therapies outside of the U.S., while also enabling us to characterize the safety and efficacy profile of our anti-Claudin 18.2 agent in a diverse patient population.”

“In parallel, we continue to advance our HER3-ADC program and look forward to sharing preclinical proof-of-concept data at AACR next month, which highlight the promising therapeutic potential of our program and support our plans to nominate a development candidate later this year. We look forward to continuing our efforts to advance important therapies for patients with significant unmet medical needs.”

Recent Business Achievements

EO-3021: A differentiated antibody-drug conjugate (ADC) for the treatment of patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers.

In February 2024, Elevation Oncology dosed the first patient in Japan in the ongoing Phase 1 clinical trial of EO-3021.

HER3-ADC: A HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3.

In March 2024, Elevation Oncology announced plans to present preclinical proof of concept data from its HER3-targeting ADC program at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10, 2024, in San Diego, CA. The abstract includes proof-of-concept data from in vitro and in vivo studies, which highlight the therapeutic potential of Elevation Oncology’s HER3-ADC program across a range of HER3-expressing cancers.

Corporate:

Elevation Oncology recently announced the appointment of three new members to its Board of Directors.
oDarcy Mootz., Ph.D. – Dr.Mootz is an experienced life sciences executive, who brings expertise across corporate strategy, corporate development, finance, and operations to the Board.
oJulie M. Cherrington, Ph.D. – Dr. Cherrington is an experienced life sciences executive, who brings insights and extensive experience advancing novel product candidates into the clinic and through commercialization to the Board.

oAlan Sandler, M.D. – Dr. Sandler is an accomplished leader in oncology and drug development, who brings experience leading clinical development and operations, regulatory affairs, drug safety and asset development strategy across industry and academia to the Board.
In March 2024, Elevation Oncology refinanced its debt facility with existing lender, K2 HealthVentures (K2HV). Under the refinanced debt facility, the interest-only payment period was extended from March 1, 2025, to June 1, 2026. Elevation Oncology issued a new common stock purchase warrant to an affiliate of K2HV, and certain terms relating to the lenders’ conversion election were amended.

Expected Upcoming Milestones:

EO-3021:

Share detail on planned Phase 1 combination study evaluating EO-3021 in the first half of 2024.
Provide update from ongoing Phase 1 clinical trial of EO-3021 in mid-2024, with additional data expected in the first half of 2025.

HER3-ADC:

Present preclinical proof-of-concept data on HER3-ADC program at the AACR Annual Meeting in April 2024.
Nominate development candidate from HER3-ADC program in 2024.

Fourth Quarter and Full Year 2023 Financial Results

As of December 31, 2023, Elevation Oncology had cash, cash equivalents and marketable securities totaling $83.1 million, compared to $90.3 million as of December 31, 2022. The decrease in cash reflects cash used to fund operating activities, partially offset by net proceeds of approximately $46.5 million from Elevation Oncology's underwritten public offering, which closed in June 2023. Subsequent to year-end, Elevation Oncology raised net proceeds of approximately $17.0 million through its at-the-market (ATM) facility.

Research and development (R&D) expenses for the fourth quarter of 2023 were $4.7 million, compared to $14.5 million for the fourth quarter of 2022. The decrease in R&D expenses in the fourth quarter of 2023 was primarily due to decreased clinical trial expenses associated with Elevation Oncology’s former lead program, partially offset by increased clinical trial expenses associated with the EO-3021 clinical trial. For the year ended December 31, 2023, R&D expenses were $25.4 million, compared to $78.7 million for the year ended December 31, 2022. The decrease 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, and decreased clinical trial expenses associated with Elevation Oncology’s former lead program, partially offset by increased clinical trial expenses associated with the EO-3021 clinical trial.

General and administrative (G&A) expenses for the fourth quarter of 2023 were $3.3 million, compared to $4.0 million for the fourth quarter of 2022. The decrease in G&A expenses in the fourth quarter of 2023 was primarily due to decreased administrative costs, including directors’ and officers’ insurance, and decreased personnel costs, including stock-based compensation. For the year ended December 31, 2023, G&A expenses were $14.9 million, compared to $15.8 million for the year ended December 31, 2022. The decrease was primarily related to a decrease in administrative costs, including directors’ and officers’ insurance.

Net loss for the fourth quarter of 2023 was $7.9 million, compared to $19.0 million for the fourth quarter of 2022.

Financial Outlook

Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of December 31, 2023, together with the approximately $17.0 million in net proceeds raised under its ATM facility, to be sufficient to fund its current operations into the fourth quarter of 2025.

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 leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. 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 and preclinical development activities, expected timing of announcements of clinical and preclinical results and trial details, 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,” “possible,” “potential,” “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, 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)

Year ended December 31, 

 

Three months ended December 31, 

    

2023

    

2022

 

2023

    

2022

Statement of Operations items:

 

  

 

  

  

 

  

Research and development

$

25,434

$

78,717

$

4,691

$

14,502

General and administrative

 

14,904

 

15,832

 

3,255

 

4,035

Restructuring charges

5,107

Total operating expenses

 

45,445

 

94,549

 

7,946

 

18,537

Loss from operations

 

(45,445)

 

(94,549)

 

(7,946)

 

(18,537)

Other income (expenses), net

 

(229)

 

(506)

 

56

 

(480)

Loss before income taxes

(45,674)

(95,055)

(7,890)

(19,017)

Income tax expense

30

25

9

25

Net loss

$

(45,704)

$

(95,080)

$

(7,899)

$

(19,042)

Net loss per share, basic and diluted

$

(1.34)

$

(4.09)

$

(0.19)

$

(0.82)

Weighted average common shares outstanding, basic and diluted

 

34,077,675

 

23,267,120

 

42,416,011

 

23,302,066


Selected Financial Information

(In thousands, except share and per share data)

(unaudited)

    

December 31, 

Selected Balance Sheet items:

2023

2022

Cash, cash equivalents and marketable securities

$

83,107

$

90,280

Working capital1

 

83,819

 

77,285

Total assets

 

89,091

 

94,161

Long-term debt, net of discount

30,137

29,435

Total stockholders' equity

 

54,809

 

49,032

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


v3.24.0.1
Document and Entity Information
Mar. 06, 2024
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Mar. 06, 2024
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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