- ELI-002 2P Phase 1 preliminary data published in Nature Medicine
- ELI-002 2P Phase 1 data characterizing the CD4 and CD8 profile of the KRAS immune response and ELI-002-generated antigen spreading presented at the AACR Annual Meeting
- ELI-002 7P Phase 1 preliminary data to be presented at the ASCO Annual Meeting (“ASCO”) in
June 2024 - ELI-002 7P randomized Phase 2 trial enrollment expected to complete in fourth quarter 2024
“During the first quarter, we continued to make great progress with our lead program, ELI-002, seeing the first-in-human Phase 1 data on the 2P formulation published in Nature Medicine. We also began enrolling patients with pancreatic cancer in the randomized Phase 2 trial of the 7P formulation,” said Robert Connelly, Elicio’s Chief Executive Officer. “We look forward to sharing preliminary data from the ELI-002 7P Phase 1 cohort at ASCO while focusing on completing enrollment for the Phase 2 randomized cohort, which is expected by the end of 2024.”
Corporate Updates
AMPLIFY-201 trial: Multicenter Phase 1 trial assessing the safety, immunogenicity, and antitumor activity of ELI-002 2P monotherapy in patients with mutant KRAS-driven solid tumors who are at high risk for relapse following standard surgery and chemotherapy.
- Data from the first-in-human study of ELI-002 2P published in Nature Medicine
- Presented clinical data at the AACR Annual Meeting highlighting results suggesting durable immunogenicity of ELI-002 2P with high relapse-risk mKRAS-driven colorectal cancer (“CRC”) and pancreatic ductal adenocarcinoma (“PDAC”).
- A majority of patients who received ELI-002 booster immunizations maintained or increased mKRAS-specific T cell responses relative to baseline. Durable responses were associated with increased memory T cell phenotype compared to baseline.
- ELI-002 induced increased mKRAS-specific CD4 and CD8 T cells with cytotoxic function, associated with increased memory phenotype in a majority of patients.
- CD4+ T regulatory cells were not induced after ELI-002 2P immunization.
- Antigen spreading was observed with T cell responses to patient-specific tumor mutations (not mKRAS) after ELI-002 2P vaccination in a majority of patients tested.
- No safety concerns were identified. No dose limiting toxicities and no ≥ grade 3 treatment related adverse events were observed.
- Data suggested several advantages of ELI-002 including lymph node-targeted vaccine design, potent immunogenicity with durable and balanced CD4+ and CD8+ T cell responses, increased T cell cytotoxic function, and antigen spreading to induce T cells targeting additional tumor mutations beyond mKRAS.
AMPLIFY-7P trial: A multicenter Phase 1/2 trial assessing ELI-002 7P in patients with high relapse risk mutant KRAS-driven solid tumors. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations expanding the number of patients eligible for inclusion and potentially reducing the chance of bypass resistance mechanisms.
- Preliminary data from the Phase 1a trial to be presented at ASCO in
June 2024 . - Randomized Phase 2 trial enrollment initiated in
January 2024 .
Upcoming Anticipated Milestones
- AMPLIFY-7P: Present preliminary data on ELI-002 7P monotherapy from Phase 1a arm at ASCO in
June 2024 . - AMPLIFY-7P: Complete enrollment in the randomized Phase 2 trial in the fourth quarter of 2024 with interim analysis expected in the first quarter of 2025.
- AMPLIFY-201: Provide updated immunogenicity and relapse-free survival data in the fourth quarter of 2024.
First Quarter 2024 Financial Results
R&D expense for the first quarter of 2024 was
G&A expense for the first quarter of 2024 was
Net loss for the first quarter of 2024 was
Cash and cash equivalents as of
Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (unaudited) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 7,559 | $ | 5,484 | ||||
General and administrative | 2,682 | 2,321 | ||||||
Total operating expenses | 10,241 | 7,805 | ||||||
Loss from operations | (10,241 | ) | (7,805 | ) | ||||
Total other expense, net | (1,586 | ) | (224 | ) | ||||
Net Loss | (11,827 | ) | (8,029 | ) | ||||
Other comprehensive loss: | ||||||||
Foreign currency translation adjustment | (73 | ) | — | |||||
Comprehensive loss | $ | (11,900 | ) | $ | (8,029 | ) | ||
Net loss per common share, basic and diluted | $ | (1.15 | ) | $ | (24.77 | ) | ||
Weighted average common shares outstanding, basic and diluted | 10,273,925 | 324,106 |
Condensed Consolidated Balance Sheets (in thousands) (unaudited) | |||||
2024 | 2023 | ||||
Assets | |||||
Cash and cash equivalents | $ | 11,853 | $ | 12,894 | |
Other current assets | 2,277 | 3,454 | |||
Total current assets | 14,130 | 16,348 | |||
Other assets | 10,350 | 10,798 | |||
Total assets | $ | 24,480 | $ | 27,146 | |
Liabilities and stockholders’ equity | |||||
Current liabilities | $ | 5,951 | $ | 9,755 | |
Long-term liabilities | 13,659 | 6,018 | |||
Total liabilities | 19,610 | 15,773 | |||
Total stockholders’ equity | 4,870 | 11,373 | |||
Total liabilities and stockholders' equity | $ | 24,480 | $ | 27,146 |
About ELI-002
Our lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (“AMP”) cancer vaccine that targets cancers that are driven by mutations in the mKRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with our AMP technology consisting of AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG adjuvant that is available as an off-the-shelf subcutaneous administration.
ELI-002 2P (2 peptide formulation) is currently being studied in an ongoing Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7 peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.
About
Cautionary Note on Forward-Looking Statements
Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding Elicio’s planned clinical programs, including planned clinical trials, the potential of Elicio’s product candidates, the expected participation and presentation at upcoming conferences, and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s financial condition, including its ability to obtain the funding necessary to advance the development of ELI-002 and any other future product candidates, and Elicio’s ability to continue as a going concern; Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of initiation of Elicio’s planned clinical trials, including Elicio’s expected completion of enrollment for the AMPLIFY-7P Phase 2 randomized trial in the fourth quarter of 2024; the timing of the availability of data from Elicio’s clinical trials, including data from the Phase 1a arm of the AMPLIFY-7P trial expected at ASCO in
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