Elevation Oncology Reports Second Quarter 2024 Financial Results and Highlights Recent Business Achievements
-- Today announced promising initial data from Phase 1 clinical trial of EO-3021; 42.8% confirmed ORR observed in Claudin 18.2-enriched subset of gastric and GEJ cancer, with differentiated safety profile --
-- Advancing into dose expansion portion of Phase 1 trial; additional monotherapy data expected in 1H 2025 --
-- Secured clinical supply agreements to evaluate EO-3021 in combination with ramucirumab and dostarlimab with Lilly and GSK, respectively; expect to initiate dosing in combination portion of the Phase 1 trial by year-end 2024 --
-- On-track to nominate development candidate for HER3-ADC program in 2H 2024 --
--
"Today, we announced promising initial data from our Phase 1 trial evaluating monotherapy EO-3021, which reinforce clinical proof-of-concept and support EO-3021's potential as a best-in-class Claudin 18.2 antibody drug conjugate. We are particularly excited to see encouraging anti-tumor activity in patients with Claudin 18.2-expressing gastric or GEJ cancer, as well as a differentiated safety profile, demonstrating the value of a targeted therapeutic approach and the benefit of EO-3021's site-specific conjugation," said
Recent Business Achievements
- Earlier today,
Elevation Oncology announced promising initial data from the dose escalation portion of the ongoing Phase 1 clinical trial of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction (GEJ), pancreatic or esophageal cancers. As of the data cutoff date ofJune 10, 2024 :- EO-3021 was observed to be generally well-tolerated. No neutropenia or peripheral neuropathy/hypoesthesia, both known toxicities associated with monomethyl auristatin E (MMAE), were observed in the safety population of 32 patients treated with EO-3021.
- In seven patients with Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+, the objective response rate (ORR) was 42.8% (three confirmed partial responses, one of which was confirmed following the
June 10, 2024 , data cutoff) and the disease control rate (DCR) was 71.4%, including two patients with stable disease (SD). - In eight patients with Claudin 18.2 in <20% of tumor cells at IHC 2+/3+, the ORR was 0% and the DCR was 50%, including four patients with SD.
- A press release with further details regarding these results is available in the News Releases section of
Elevation Oncology's investor relations website at https://investors.elevationoncology.com. - In
June 2024 ,Elevation Oncology announced plans to expand its ongoing Phase 1 clinical trial of EO-3021 to include two combination cohorts evaluating EO-3021 for the treatment of advanced gastric or GEJ cancer. Pursuant to clinical supply agreements with Lilly and Company and GSK, respectively,Elevation Oncology will evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in the second-line setting and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting.
Expected Upcoming Milestones
EO-3021:
- Initiate dosing in combination portion of the ongoing Phase 1 clinical trial of EO-3021 by year-end 2024.
- Share additional data from the ongoing Phase 1 clinical trial of monotherapy EO-3021, including from the dose expansion cohort, in the first half of 2025.
HER3-ADC:
- Nominate development candidate from HER3-ADC program in the second half of 2024.
Second Quarter 2024 Financial Results
As of
Research and development (R&D) expenses for the second quarter of 2024 were
General and administrative (G&A) expenses for the second quarter of 2024 were
Net loss for the second quarter of 2024 was
Financial Outlook
Conference Call Information
A webcast of the call will also be available on the Events page of
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) with best-in-class potential comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2. EO-3021 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 normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents.
About
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 results, potential benefits of
Elevation Oncology Investor and Media Contact
EVP, Managing Director, Precision AQ
hannah.deresiewicz@precisionaq.com
Selected Financial Information |
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(In thousands, except share and per share data) |
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(unaudited) |
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|
|
|
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Three months ended |
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|
|
2024 |
|
2023 |
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Statement of Operations items: |
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|
|
|
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Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
6,551 |
|
$ |
6,029 |
General and administrative |
|
|
4,412 |
|
|
3,805 |
Total operating expenses |
|
|
10,963 |
|
|
9,834 |
Loss from operations |
|
|
(10,963) |
|
|
(9,834) |
Other income (expense): |
|
|
|
|
|
|
Interest income (expense), net |
|
|
513 |
|
|
(271) |
Total other income (expense), net |
|
|
513 |
|
|
(271) |
Loss before income taxes |
|
|
(10,450) |
|
|
(10,105) |
Income tax expense |
|
|
11 |
|
|
5 |
Net loss |
|
$ |
(10,461) |
|
$ |
(10,110) |
Net loss per share, basic and diluted |
|
$ |
(0.18) |
|
$ |
(0.36) |
Weighted average common shares outstanding, basic and diluted |
|
|
59,018,340 |
|
|
28,405,046 |
Selected Financial Information |
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(In thousands, except share and per share data) |
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(unaudited) |
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|
|
|
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Selected Balance Sheet items: |
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Cash, cash equivalents and marketable securities |
|
$ |
110,849 |
|
$ |
83,107 |
Working capital1 |
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|
110,806 |
|
|
83,819 |
Total assets |
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|
114,597 |
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|
89,091 |
Long-term debt, net of discount |
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|
30,916 |
|
|
30,137 |
Total stockholders' equity |
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|
80,918 |
|
|
54,809 |
|
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1 We define working capital as current assets less current liabilities. |
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