Completed enrollment of Phase 2 AMPLIFY-7P randomized study; disease-free survival (“DFS”) event-driven interim analysis expected in Q3 2025
Aligned with U.S. Food and Drug Administration (“FDA”) on key elements of planned ELI-002 Phase 3 study design, including dose, patient population and primary endpoint analysis
Strengthened cash position to support operations beyond the anticipated AMPLIFY-7P Phase 2 interim analysis
BOSTON, March 31, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the year ending December 31, 2024 and provided recent corporate and clinical updates.
“We made substantial progress in 2024 advancing our cancer immunotherapy pipeline and achieving major milestones, including completing enrollment in our first randomized Phase 2 clinical trial. We believe that ELI-002 could play a transformational role in preventing the recurrence of difficult-to-treat KRAS-mutant cancers,” said Robert Connelly, Chief Executive Officer of Elicio. “During the fourth quarter, we presented highly encouraging ELI-002 Phase 1a data at major medical meetings. Across two monotherapy trials that enrolled a total of 39 patients, we observed strong concordance between T cell response and anti-tumor activity—with antigen spreading beyond KRAS to other personalized tumor neo-antigens. Data presented at the Society for Immunotherapy of Cancer (“SITC”) 2024 Annual Meeting and the European Society for Medical Oncology (“ESMO”)Immuno-Oncology Congress 2024 pointed to a potential DFS benefit for patients. Reflecting strong interest from patients and trial investigators, enrollment in our Phase 2 AMPLIFY-7P trial was completed on schedule, and the study is progressing toward a DFS event-driven interim analysis expected in Q3 2025, depending on rate of event accrual. We’re looking forward to working with our investigators to initiate a clinical study of ELI-002 in additional KRAS-mutated tumor indications. Additionally, we have taken steps to strengthen our balance sheet to support operations into Q4 2025, beyond the upcoming interim analysis.”
Recent Highlights
In March 2025, Elicio appointed Preetam Shah, Ph.D., MBA, as Chief Strategy and Financial Officer.
In January 2025, Elicio strengthened its cash position with a $10.0 million registered direct offering of common stock.
In January 2025, Elicio reached alignment with regulatory authorities on a registrational strategy for ELI-002 in post-resection (adjuvant setting) mKRAS pancreatic ductal adenocarcinoma (“PDAC”). Specifically, Elicio aligned with the FDA on key elements of a planned Phase 3 study design—including dose, schedule, patient population and primary endpoint analysis based on DFS.
In December 2024, Elicio announced the completion of enrollment of the randomized Phase 2 AMPLIFY-7P clinical trial (NCT05726864). The trial has successfully enrolled 144 post-resection mKRAS PDAC patients, randomized 2:1 to receive ELI-002 or observational standard-of-care.
In December 2024, Elicio presented updated results from the Phase 1a AMPLIFY-201 clinical trial (NCT04853017) of ELI-002 at the ESMO Immuno-Oncology Congress 2024. Updated Phase 1a results included a 16.3-month median recurrence-free survival (“mRFS”), a 28.9-month median overall survival (“mOS”) from full study population and a strong correlation between mRFS and strength of T cell response.
In November 2024, Elicio presented updated translational data from the Phase 1a AMPLIFY-7P clinical trial (NCT05726864) at the SITC 2024 Annual Meeting, demonstrating favorable safety, durable and dose-dependent T cell responses targeting KRAS mutations and induced responses to patient-specific neoantigens and a strong correlation between DFS and T cell response.
Upcoming Anticipated Milestones
DFS event-driven interim analysis of Phase 2 AMPLIFY-7P clinical trial in Q3 2025, depending on rate of event accrual
Potential to finalize pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS PDAC in H2 2025
2024 Financial Results
R&D expense for 2024 was $33.7 million, compared to $23.8 million 2023. The increased R&D expense was primarily related to clinical trial expenses associated with the ongoing Phase 2 AMPLIFY-7P Phase 2, partially offset by cost-cutting operational changes implemented during Q3 2024.
G&A expense for 2024 was $11.3 million, compared to $11.9 million for 2023.
Net loss for 2024 was $51.9 million, compared to $35.2 million for 2023. Net loss for 2024 includes $6.9 million of non-cash other income resulting from the change in fair value of the warrant liability. Net loss per share for 2024 was $4.25 compared to $6.96 for 2023.
Cash and cash equivalents, as of December 31, 2024, were $17.6 million, compared to $12.9 million as of December 31, 2023.
Including $10.0 million in gross proceeds from the January 2025 registered direct offering, the Company expects current cash and cash equivalents to support operations into Q4 2025, beyond the anticipated AMPLIFY-7P Phase 2 interim analysis.
ELICIO THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
Year Ended December 31,
2024
2023
Operating expenses:
Research and development
$
33,656
$
23,849
General and administrative
11,330
11,896
Total operating expenses
44,986
35,745
Loss from operations
(44,986
)
(35,745
)
Total other (expense) income, net
(6,912
)
550
Net loss
(51,898
)
(35,195
)
Other comprehensive gain (loss):
Foreign currency translation adjustment
22
(197
)
Comprehensive loss
$
(51,876
)
$
(35,392
)
Net loss per common share, basic and diluted
$
(4.25
)
$
(6.96
)
Weighted average common shares and pre-funded warrants outstanding, basic and diluted
12,202,996
5,056,225
ELICIO THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31, 2024
December 31, 2023
Assets
Cash and cash equivalents
$
17,618
$
12,894
Other current assets
3,075
3,454
Total current assets
20,693
16,348
Other assets
7,485
10,798
Total assets
$
28,178
$
27,146
Liabilities and stockholders' (deficit) equity
Current liabilities
$
11,523
$
9,755
Long-term liabilities
27,967
6,018
Total liabilities
39,490
15,773
Total stockholders' (deficit) equity
(11,312
)
11,373
Total liabilities and stockholders' (deficit) equity
$
28,178
$
27,146
Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical successes in the personalized cancer vaccine space to develop effective, off-the-shelf vaccines. Elicio’s Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 lead program is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. ELI-002 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer vaccines, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit www.elicio.com.
About ELI-002
Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer vaccine that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.
ELI-002 2P (2-peptide formulation) has been studied in the 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 the Amphiphile Platform
Elicio’s proprietary AMP platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies.
Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.
The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. In preclinical models, Elicio observed lymph node-specific engagement driving immune responses of increased magnitude, function and durability.
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 the sufficiency of Elicio’s existing cash and cash equivalents to support operations; expectations about Elicio’s financial and operating results; Elicio’s planned clinical programs, including planned clinical trials and the potential to finalize pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS PDAC in the second half of 2025, the potential of Elicio’s product candidates, including the potential transformational role ELI-002 could play in preventing the recurrence of difficult-to-treat KRAS-mutant cancers 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 anticipated cash runway and 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 working with investigators to initiate the ELI-002 clinical study in additional KRAS-mutated tumor indications; the timing of the availability of data from Elicio’s clinical trials, including the DFS event-driven interim analysis, from the AMPLIFY-7P trial expected in the third quarter of 2025, depending on rate of event accrual; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; and Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in the Annual Report on Form 10-K filed with the SEC on March 31, 2025, under the heading “Risk Factors” and any subsequent reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.
