Announcement • Aug 11
Elicio Therapeutics Announces Activation Of Investigator-Initiated Phase 1 Study Of Neoadjuvant ELI-002 7P For Pancreatic Ductal Adenocarcinoma Elicio Therapeutics, Inc. announced the opening of the investigator-initiated Phase 1 neoadjuvant study (NCT07671339) evaluating ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor in borderline resectable and resectable pancreatic ductal adenocarcinoma. The multi-center investigator-initiated trial is being conducted by Memorial Sloan Kettering Cancer Center and is being funded by a strategic partnership between The Lustgarten Foundation and Break Through Cancer. The randomized, open-label Phase 1 trial aims to enroll 20 patients with resectable or borderline resectable KRAS-mutant pancreatic ductal adenocarcinoma. Participants will receive ELI-002 7P with standard chemotherapy, mFOLFIRINOX, with or without tislelizumab, an anti-PD1 checkpoint inhibitor, starting before surgery. Throughout treatment, researchers plan to collect tumor tissue and blood samples to better understand immune activation, characterize changes within the tumor microenvironment, and identify biomarkers that could guide future clinical trials. Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy 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 proprietary 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 7P (7-peptide formulation) was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The Phase 2 AMPLIFY-7P trial included patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Elicio continues to evaluate pre-specified subgroups, including the R0 resected population, to further inform a refined Phase 3 development strategy. Elicio intends to initiate a Phase 1 study in metastatic pancreatic ductal adenocarcinoma designed to provide a rapid assessment of clinical activity using an open label design to assess the objective response rate including partial and complete radiographic responses. Elicio plans to use the study findings to further evaluate checkpoint inhibitor combinations and help inform future development strategies in metastatic pancreatic ductal adenocarcinoma and the adjuvant pancreatic ductal adenocarcinoma Phase 3 trial. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. 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. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer in Phase 1 studies. In the future, Elicio plans to expand ELI-002 7P to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer immunotherapy candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. New Risk • Jul 24
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 47% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (37% average weekly change). Negative equity (-US$1.4m). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (47% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$83m net loss in 3 years). Market cap is less than US$100m (US$74.3m market cap). Announcement • Jul 07
Elicio Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $15.024474 million. Elicio Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $15.024474 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,380,313
Price\Range: $3.43
Discount Per Security: $0.24
Transaction Features: Registered Direct Offering 
