— Offered preclinical knowledge for probably differentiated HER3 ADC, EO-1022, at AACR Annual Assembly —
— Expects to file IND software for EO-1022 in 2026 —
— Money runway into 2H 2026 —
BOSTON, Might 15, 2025 /PRNewswire/ — Elevation Oncology, Inc. (Nasdaq: ELEV), an modern oncology firm centered on the invention and improvement of selective most cancers therapies to deal with sufferers throughout a variety of stable tumors with important unmet medical wants, at present introduced monetary outcomes for the quarter ended March 31, 2025, and supplied latest enterprise updates.
“We just lately introduced preclinical proof-of-concept knowledge for EO-1022, reaffirming its potential as a differentiated HER3 ADC, and supporting our objective of offering a safer and more practical choice for sufferers with HER3-expressing stable tumors,” stated Joseph Ferra, President and Chief Govt Officer of Elevation Oncology. “In parallel, we’re engaged in efforts to discover a variety of strategic alternate options, with the target of figuring out and capitalizing on the chance that’s in the perfect curiosity of our shareholders. We stay up for offering an replace on the applicable time.”
Current Enterprise Updates
Pipeline
Elevation Oncology is creating EO-1022, a HER3 antibody-drug conjugate (ADC) for the remedy of sufferers with HER3-expressing stable tumors, together with breast most cancers and non-small cell lung most cancers. The Firm expects to file an Investigational New Drug (IND) software for EO-1022 in 2026.
- In April 2025, Elevation Oncology introduced new preclinical proof-of-concept knowledge supporting the event of EO-1022 in a late-breaking poster on the American Affiliation for Most cancers Analysis (AACR) Annual Assembly. The in vitro and in vivo knowledge point out EO-1022 could supply lowered payload-associated toxicity and an improved security profile, in addition to improved anti-tumor exercise, for sufferers residing with stable tumors that specific HER3. Particularly, knowledge present:
- EO-1022 is extremely secure in human serum, with a homogenous drug-to-antibody ratio (DAR) of 4 and minimal free payload in comparison with seribantumab-vcMMAE and patritumab-DXd, two benchmark HER3 ADCs, each of which use stochastic conjugation. These findings illustrate {that a} key function of EO-1022 is minimal systemic publicity to free payload, probably leading to lowered payload-associated toxicity in sufferers and an improved security profile.
- EO-1022 displays potent in vitro cytotoxicity that’s depending on HER3 expression ranges.
- EO-1022 elicits anti-tumor exercise in in vivo fashions of low, medium and excessive HER3 expression ranges, together with in a affected person derived xenograft (PDX) mannequin of low HER3-expressing EGFR-mutant lung most cancers.
Company
- In March 2025, Elevation Oncology elected to discontinue improvement of EO-3021. In parallel, the Firm carried out a workforce discount of roughly 70%. Elevation Oncology is within the means of evaluating strategic choices with a dedication to maximizing shareholder worth. There may be at present no timetable set for completion of the strategic alternate options assessment course of.
Monetary Outlook
Elevation Oncology ended the primary quarter of 2025 with $80.7 million in money, money equivalents and marketable securities. Subsequent to the primary quarter, on Might 2, 2025, Elevation Oncology voluntarily pay as you go the $32.3 million combination principal, curiosity, charges and bills due underneath its mortgage settlement with K2 HealthVentures LLC. Elevation Oncology expects {that a} important majority of bills incurred in relation to its workforce discount and EO-3021 program closure will probably be paid within the second quarter of 2025.
Elevation Oncology estimates that it’s going to have money, money equivalents and marketable securities in a variety of roughly $30 million to $35 million as of June 30, 2025, which is anticipated to fund its present operations into the second half of 2026.
First Quarter 2025 Monetary Outcomes
Analysis and improvement bills for the primary quarter of 2025 had been $6.9 million, in comparison with $6.0 million for the primary quarter of 2024. The rise of $0.9 million was primarily attributable to $1.3 million of elevated prices related to the preclinical improvement of EO-1022 and a $0.6 million improve in scientific trial bills for EO-3021, partially offset by a $1.0 million lower in scientific trial bills for seribantumab.
Basic and administrative bills for the primary quarter of 2025 had been $4.0 million, in comparison with $3.9 million for the primary quarter of 2024. The rise of $0.1 million was primarily attributable to elevated personnel prices, together with stock-based compensation.
Restructuring costs had been $3.4 million for the primary quarter of 2025 and consisted primarily of costs associated to the workforce discount in reference to the discontinuation of improvement of EO-3021. No such costs had been incurred throughout the first quarter of 2024.
Web loss for the primary quarter of 2025 was $14.2 million, in comparison with $10.7 million for the primary quarter of 2024.
About EO-1022
Elevation Oncology is creating EO-1022, a probably differentiated HER3 ADC for the remedy of HER3-expressing stable tumors, together with breast most cancers and non-small cell lung most cancers. EO-1022 consists of seribantumab, a totally human IgG2 anti-HER3 antibody, site-specifically conjugated at glycan to the MMAE payload with a DAR of 4. It leverages seribantumab’s fascinating internalization properties and superior site-specific ADC expertise which makes potential the usage of the potent cytotoxic MMAE payload. Elevation Oncology expects to file an IND software in 2026.
About Elevation Oncology, Inc.
Elevation Oncology is an modern oncology firm centered on the invention and improvement of selective most cancers therapies to deal with sufferers throughout a variety of stable tumors with important unmet medical wants. We’re leveraging our ADC experience to advance EO-1022, a HER3 ADC for the remedy of sufferers with HER3-expressing stable tumors. EO-1022 is at present progressing by means of preclinical improvement, with an IND software anticipated in 2026. For extra data, go to www.ElevationOncology.com.
Ahead-Wanting Statements
This press launch comprises forward-looking statements inside the that means of the “secure harbor” provisions of the Personal Securities Litigation Reform Act of 1995, together with, however not restricted to, anticipated scientific and preclinical improvement actions, anticipated timing of regulatory submissions, potential advantages of product candidates, potential market alternatives for product candidates, the flexibility of product candidates to deal with their focused indications, anticipated prices related to company restructuring, the analysis of strategic choices and Elevation Oncology’s expectations about its money, money equivalents and marketable securities and its money runway. All statements aside from statements of historic truth are statements that might be deemed forward-looking statements. These forward-looking statements could also be accompanied by such phrases as “purpose,” “anticipate,” “imagine,” “may,” “estimate,” “anticipate,” “forecast,” “objective,” “intend,” “could,” “may,” “plan,” “potential,” “potential,” “will,” “would,” and different phrases and phrases of comparable that means. Though Elevation Oncology believes that the expectations mirrored in such forward-looking statements are cheap, Elevation Oncology can’t assure future occasions, outcomes, actions, ranges of exercise, efficiency or achievements, and the timing and outcomes of biotechnology improvement and potential regulatory approval are inherently unsure. Ahead-looking statements are topic to dangers and uncertainties that will trigger Elevation Oncology’s precise actions or outcomes to vary considerably from these expressed in any forward-looking assertion, together with dangers and uncertainties associated to Elevation Oncology’s potential to advance its product candidates, the timing and outcomes of preclinical research and scientific trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology’s potential to fund improvement actions and obtain improvement targets, Elevation Oncology’s potential to guard mental property, Elevation Oncology’s potential to ascertain and keep collaborations with third events, and different dangers and uncertainties described underneath the heading “Danger Components” in paperwork Elevation Oncology recordsdata now and again with the Securities and Change Fee. These forward-looking statements communicate solely as of the date of this press launch, and Elevation Oncology undertakes no obligation to revise or replace any forward-looking statements to mirror occasions or circumstances after the date hereof.
Elevation Oncology Investor and Media Contact
Gracie Tong
Senior Director, Investor Relations and Company Communications
[email protected]
Chosen Monetary Info | ||||||
Three months ended March 31, | ||||||
2025 | 2024 | |||||
Assertion of Operations gadgets: | ||||||
Working bills: | ||||||
Analysis and improvement | $ | 6,876 | $ | 6,011 | ||
Basic and administrative | 3,965 | 3,858 | ||||
Restructuring costs | 3,375 | — | ||||
Complete working bills | 14,216 | 9,869 | ||||
Loss from operations | (14,216) | (9,869) | ||||
Different revenue (expense): | ||||||
Curiosity revenue, internet | 11 | 115 | ||||
Loss on extinguishment of debt | — | (942) | ||||
Complete different revenue (expense), internet | 11 | (827) | ||||
Loss earlier than revenue taxes | (14,205) | (10,696) | ||||
Earnings tax expense | 6 | 11 | ||||
Web loss | $ | (14,211) | $ | (10,707) | ||
Web loss per share, fundamental and diluted | $ | (0.24) | $ | (0.21) | ||
Weighted common frequent shares excellent, fundamental and diluted | 59,173,854 | 51,811,882 |
Chosen Monetary Info | ||||||
Chosen Steadiness Sheet gadgets: | March 31, 2025 | December 31, 2024 | ||||
Money, money equivalents and marketable securities | $ | 80,659 | $ | 93,184 | ||
Working capital1 | 77,958 | 90,259 | ||||
Complete belongings | 82,223 | 95,626 | ||||
Lengthy-term debt, internet of low cost | 31,253 | 31,134 | ||||
Complete stockholders’ fairness | 46,734 | 60,025 |
1. | We outline working capital as present belongings much less present liabilities. |
SOURCE Elevation Oncology