Last update 10 Nov 2024
ELI-002 7P
Last update 10 Nov 2024
Overview
Basic Info
Drug Type Immune cell therapy |
Synonyms- |
Target |
Mechanism KRAS inhibitors(GTPase KRas inhibitors) |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 1/2 |
First Approval Date- |
Regulation- |
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Related
1
Clinical Trials associated with ELI-002 7PFirst in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
Start Date14 Apr 2023 |
Sponsor / Collaborator |
100 Clinical Results associated with ELI-002 7P
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100 Translational Medicine associated with ELI-002 7P
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100 Patents (Medical) associated with ELI-002 7P
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11
News (Medical) associated with ELI-002 7P07 Nov 2024
Preliminary data demonstrate durable and dose-dependent T cell responses targeting KRAS mutations and induced responses to patient-specific neoantigens Correlation observed between disease-free survival (“DFS”) and T cell response ELI-002 Phase 1 safety and tolerability profile remains favorable ELI-002 Phase 2 interim event-driven DFS analysis expected in H1 2025 BOSTON, Nov. 07, 2024 (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, presented updated preliminary results from the ongoing AMPLIFY-7P Phase 1 clinical trial (NCT05726864) of ELI-002, an Amphiphile (“AMP”) cancer vaccine that targets KRAS-mutant tumors at the Society for Immunotherapy of Cancer (“SITC”) 2024 Annual Meeting. The poster presentation includes updated translational data highlighting the relationship between vaccine immunogenicity and DFS. The AMPLIFY-7P study is evaluating ELI-002 in patients with mKRAS-driven solid tumors following standard locoregional treatment and who remain at risk of disease recurrence. The randomized Phase 2 portion of AMPLIFY-7P in patients with pancreatic cancer is ongoing, with enrollment expected to be completed in Q4 2024. ELI-002 immunogenicity was based on a longitudinal ex vivo analysis of peripheral T cells collected from a total of 12 evaluable patients who received either a 1.4 mg dose or the recommended Phase 2 dose (“RP2D”) of 4.9 mg, with a September 11, 2024 cutoff date. Key observations include: mKRAS-specific T cell responses versus baseline were observed in all evaluable patients; median response in 4.9 mg (RP2D) group was 12-fold higher than the 1.4 mg dose groupT cell specificities covered all seven KRAS mutants targeted by ELI-002; strongest responses observed were against the most common variants, including KRAS G12R, G12D, and G12VInduced mKRAS-specific T cells were fully functional and capable of secreting both granzyme B and perforinMagnitude of T cell response correlated with duration of DFS, based on a May 23, 2024 cutoff date; highest three quartiles of T cell responders have not yet reached mDFS, whereas the lowest quartile achieved a mDFS of 3.1 months (p=0.0027)T cell responses against mKRAS antigens were shown to be durable, extending up to 1.5 yearsAntigen spreading detected in 100% of RP2D-treated patients (n=6), with T cell responses observed against 67.5% of tested neoantigens identified from patient-specific mutanomes—suggesting ELI-002-induced tumor immunosurveillance to personalized tumor neoantigens beyond mKRASAs of a May 23, 2024 safety data cutoff, ELI-002 remains safe and well-tolerated, with no dose-limiting toxicities or cytokine release syndrome observed Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development and Chief Medical Officer, commented, “We are encouraged to see a robust expansion of T cells targeting mutant KRAS antigens as well as a clear relationship between T cell response and DFS in the Phase 1 portion of AMPLIFY-7P. Furthermore, we are encouraged by the observed induced T cell reactivity against personalized neoantigens, which could improve the breadth and durability of tumor immunosurveillance. These data recapitulate the previous findings from the separate AMPLIFY-201 study, published earlier this year in Nature Medicine. We expect to provide an additional clinical data update from AMPLIFY-201 in December.” About Elicio Therapeutics Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies to prevent the recurrence 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 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 Our 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 our 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 Our proprietary AMP platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe 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, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies. Our 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, we have 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 Elicio’s planned clinical programs, including planned clinical trials, the potential of Elicio’s product candidates, including the observed induced T cell reactivity against personalized neoantigens, which could improve the breadth and durability of tumor immunosurveillance; the expected participation and presentation at upcoming conferences and medical meetings, 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 Elicio’s expected completion of enrollment for the AMPLIFY-7P Phase 2 randomized clinical trial in the fourth quarter of 2024; the timing of the availability of data from Elicio’s clinical trials, including updated data from the AMPLIFY-201 trial expected in December 2024 and Phase 2 interim event-driven DFS analysis from the AMPLIFY-7P trial expected in the first half of 2025; 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 29, 2024, as amended on April 29, 2024, 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. Investor Relations Contact Carlo Tanzi, Ph.D.ctanzi@kendallir.com
ImmunotherapyVaccinePhase 1Clinical ResultPhase 2
31 Oct 2024
Poster presentation at SITC to highlight extended follow-up data from AMPLIFY-7P Phase 1 study Oral presentation at SU2C Innovation Summit to highlight data from AMPLIFY-7P and AMPLIFY-201 Phase 1 studies BOSTON, Oct. 31, 2024 (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 announced two upcoming presentations in November. The first presentation will take place at the upcoming Society for Immunotherapy of Cancer (“SITC”) 39th Annual Meeting, being held November 6-10, 2024, in Houston, Texas. The presentation will include updated T cell and Disease-Free Survival (“DFS”) data from the ongoing AMPLIFY-7P Phase 1 clinical trial (NCT05726864) of ELI-002, an Amphiphile (“AMP”) cancer vaccine that targets KRAS-mutant tumors. The Phase 2 portion of AMPLIFY-7P is ongoing in patients with pancreatic cancer with enrollment expected to complete in Q4 2024. Poster Presentation Details Title: AMPLIFY-7P Phase 1a: Lymph node-targeted amphiphile therapeutic cancer vaccine in patients with high relapse risk KRAS mutated pancreatic ductal adenocarcinoma and colorectal cancer (Abstract #1473) Session Date and Time: Friday, November 8, 2024, 12:15-1:45 p.m. ET The second presentation will take place at the Stand Up To Cancer (“SU2C”) Innovation Summit: Cancer Detection and Vaccines, being held November 4, 2024, in New York. Peter Demuth, Ph.D., Executive Vice President, Chief Scientific Officer of Elicio Therapeutics, will present updates on the AMP platform and data from the AMPLIFY-7P (NCT05726864) and AMPLIFY-201 (NCT04853017) Phase 1 trials. Oral Presentation Details Title: Targeting Cancer Vaccination to the Lymph Nodes to Promote Anti-tumor Immunity Session Date and Time: Monday, November 4, 2024, 2:45 p.m. ET About Elicio Therapeutics Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing a pipeline of novel lymph node-targeted immunotherapies for the treatment of some of the most aggressive cancers. By combining expertise in immunology and immunotherapy, Elicio is harnessing the natural power of the immune system with the AMP technology, which allows for therapeutic payloads to be delivered directly to the lymph nodes, with the goal of enhancing the immune system’s cancer-fighting capabilities. By targeting cancer immunotherapies to the core of the immune response, AMP aims to optimize the lymph nodes’ natural ability to educate, activate and amplify cancer-specific T cells, which are essential for recognizing and eliminating tumor cells. Engineered to synchronize immunity in these highly potent sites, AMP is built to enhance the magnitude, potency, quality and durability of the immune response to drive antitumor activity. Elicio’s R&D pipeline includes off-the-shelf therapeutic cancer vaccines ELI-002, (targeting mKRAS-driven cancers) as well as ELI-007 and ELI-008 (targeting BRAF-driven cancers and p53 hotspot mutations, respectively). For more information, please visit www.elicio.com. 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 KRAS-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 the Amphiphile Platform Our proprietary AMP platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe 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, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies. Our 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 bloodstream, as it travels to lymphatic tissue. In preclinical models, we have 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 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 medical meetings, 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; the timing of the availability of data from Elicio’s clinical trials, including updated T cell and DFS data from the ongoing AMPLIFY-7P Phase 1 clinical trial of ELI-002; 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 29, 2024, as amended on April 29, 2024, 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. Investor Relations Contact Carlo Tanzi, Ph.D.ctanzi@kendallir.com
ImmunotherapyPhase 1VaccineAACR
13 Aug 2024
• AMPLIFY-7P Phase 1 preliminary disease-free (“DFS”) survival demonstrates strong correlation between T cell response and reduced risk of progression or death• AMPLIFY-7P Phase 1 data presented at ASCO demonstrated 100% of patients develop mKRAS-specific T-cell response with ~66% of responses including both CD4+ and CD8+ T cells• Long term follow up of the AMPLIFY-201 Phase 1 study will be terminated, and long term follow up of the AMPLIFY-7P Phase 1 study will be minimized to collect only overall survival to preserve resources with updated data to be shared at upcoming medical meetings• AMPLIFY-7P Phase 2 randomized clinical trial anticipated to complete 135-patient enrollment in the fourth quarter of 2024• $43 million raised in 2024 funds Elicio into the second quarter of 2025 BOSTON, Aug. 13, 2024 (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 second quarter ended June 30, 2024 and provided recent corporate and clinical updates. “During the second quarter, we continued to make great progress with our lead program sharing the first clinical data from the 7-peptide version of ELI-002 and are continuing to see robust enrollment in the randomized Phase 2 trial. We remain encouraged by the early clinical data from the ELI-002 Phase 1 trial, including T-cell response and biomarker reduction, and are energized by the rate of enrollment in the ongoing Phase 2 trial. Having completed enrollment and dosing of 39 patients across both Phase 1 trials, we will be winding down the Phase 1 trials after conducting a final data cut later this summer and look forward to sharing the longer-term follow up data at upcoming medical meetings,” said Robert Connelly, Chief Executive Officer of Elicio. “With the recently announced financings we are funded into the second quarter of 2025 beyond when we expect to have the interim analysis readout of the ongoing randomized Phase 2 trial of ELI-002 monotherapy in PDAC.” Christopher Haqq, M.D., Ph.D., Elicio’s Chief Medical Officer, added, “We were encouraged by and excited to share the initial clinical data from the 7-peptide ELI-002 Phase 1 trial. The data demonstrated the 7-peptide formulation is well-tolerated while generating a significantly larger T cell response compared to the 2-peptide formulation. Importantly, the ELI-002 7P immune response included CD4+ and CD8+ T cells and generated antigen-spreading as was seen in the 2-peptide data shared earlier this year. As of our May 24, 2024 data cutoff date, preliminary data showed patients receiving ELI-002 7P at the recommended Phase 2 dose (“RP2D”) of 4.9 mg AMP-peptide were yet to reach the median disease-free survival (“mDFS”). Based on the potential to target mutant KRAS using the immune response supported by initial Phase 1 data, we look forward to demonstrating the potential of ELI-002 in late phase trials as clinical development proceeds.” 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 treatment and potentially reducing the chance of bypass resistance mechanisms. Preliminary Phase 1a trial data based on the May 24, 2024 data cutoff date was shared in June 2024. The mDFS has not yet been reached (n=14).The mDFS has not been reached in patients receiving the 4.9mg AMP-peptide dose (n=8) vs. 12.6 weeks for patients receiving the 1.4mg AMP-peptide dose (n=6).Patients achieving a reduction in their tumor biomarker levels had no progression events vs. mDFS of 11.0 weeks for patients whose tumor biomarker did not respond to ELI-002 7P.Patients with an above median T cell response to ELI-002 have had no progression events. As of the December 18, 2023 data cutoff date, polyfunctional mKRAS-specific T cells were observed in 100% (n = 11/11) of evaluable patients. Both CD8+ and CD4+ responses were induced in 66.7% (4/6) of evaluable patients, at the RP2D 4.9 mg dose level, with higher median fold-change from baseline.Biomarker reductions were observed in 2/5 (40%) at the 1.4 mg AMP-Peptides 7P dose level and in 5/7 (71%) at the RP2D 4.9 mg dose level in patients with reductions/clearance observed for all the common G12 (G12D, G12V, G12R) and G13 (D) KRAS mutations enrolled in the study to date.Minimum residual disease clearance was observed in one (1) G12V pancreatic (“PDAC”) patient at 4.9 mg.Antigen-spreading was observed with increased T cell responses targeting non-immunizing, personalized tumor neoantigens were observed in 7/10 (70%) evaluable patients, 6/6 (100%) evaluable patients treated at the 4.9 mg RP2D dose level.No dose-limiting toxicities, no treatment-related serious adverse events and no cytokine release syndrome were observed. Randomized Phase 2 trial enrollment expected to complete in the fourth quarter of 2024. Upcoming Anticipated Milestones AMPLIFY-201: Provide updated immunogenicity and relapse free survival data in the fourth quarter of 2024.AMPLIFY-7P: Provide updated preliminary DFS data from ELI-002 7P monotherapy Phase 1a arm in the first quarter of 2025.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. Second Quarter 2024 Financial Results R&D expense for the second quarter of 2024 was $8.2 million, compared to $4.9 million for the second quarter of 2023. The increase in R&D expense was primarily due to increased clinical trial expenses associated with the ongoing AMPLIFY-7P Phase 1a and Phase 2 trials. G&A expense for the second quarter of 2024 was $2.7 million, compared to $2.8 million for the second quarter of 2023. Net loss for the second quarter of 2024 was $7.2 million, compared to $7.6 million for the second quarter of 2023. Net loss for the second quarter of 2024 includes $3.6 million of non-cash other income resulting from the change in fair value of the warrant liability. Net loss per share for the second quarter of 2024 was $0.64 compared to $2.61 for the second quarter of 2023. Cash and cash equivalents as of June 30, 2024, were $3.4 million, compared to $12.9 million as of December 31, 2023. Cash and cash equivalents as of June 30, 2024 does not include $9.9 million of net proceeds from the public offering that was received on July 1, 2024 and the $19.7 million of net proceeds from the convertible note financing that was received on August 12, 2024. ELICIO THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts)(unaudited) Three Months Ended June 30, 2024 2023 Operating expenses: Research and development$8,180 $4,944 General and administrative 2,744 2,833 Total operating expenses 10,924 7,777 Loss from operations (10,924) (7,777) Total other income 3,695 218 Net Loss (7,229) (7,559) Other comprehensive income (loss): Foreign currency translation adjustment 32 (2) Comprehensive loss$ (7,197) $(7,561) Net loss per common share, basic and diluted$(0.64) $(2.61) Weighted average common shares outstanding, basic and diluted 11,284,853 2,893,244 ELICIO THERAPEUTICS, INC. Condensed Consolidated Balance Sheets(in thousands)(unaudited) AssetsJune 30, 2024 December 31, 2023Cash and cash equivalents$3,425 $12,894Other current assets3,264 3,454Total current assets6,689 16,348Other assets9,061 10,798Total assets$15,750 $27,146
Liabilities and stockholders’ equity Current liabilities$7,585 $9,755Long-term liabilities9,817 6,018Total liabilities17,402 15,773Total stockholders’ equity (deficit)(1,652) 11,373Total liabilities and stockholders' equity$15,750 $27,146 About Elicio Therapeutics Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing a pipeline of novel lymph node-targeted immunotherapies for the treatment of some of the most aggressive cancers. By combining expertise in immunology and immunotherapy, Elicio is harnessing the natural power of the immune system with the AMP technology, which allows for therapeutic payloads to be delivered directly to the lymph nodes, with the goal of enhancing the immune system’s cancer-fighting capabilities. By targeting cancer immunotherapies to the core of the immune response, AMP aims to optimize the lymph nodes’ natural ability to educate, activate and amplify cancer-specific T cells, which are essential for recognizing and eliminating tumor cells. Engineered to synchronize immunity in these highly potent sites, AMP is built to enhance the magnitude, potency, quality and durability of the immune response to drive antitumor activity. Elicio’s R&D pipeline includes off-the-shelf therapeutic cancer vaccines ELI-002, (targeting mKRAS-driven cancers) as well as ELI-007 and ELI-008 (targeting BRAF-driven cancers and p53 hotspot mutations, respectively). For more information, please visit www.elicio.com. About the Amphiphile Platform Our proprietary Amphiphile (“AMP”) platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe 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, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies. Our 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 bloodstream, as it travels to lymphatic tissue. In preclinical models, we have 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 fund operating expenses and capital expenditure requirements into the second quarter of 2025, 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 medical meetings, 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 Elicio’s expected completion of enrollment for the AMPLIFY-7P Phase 2 randomized clinical trial in the fourth quarter of 2024; the timing of the availability of data from Elicio’s clinical trials, including updated immunogenicity and relapse free survival data from the AMPLIFY-201 trial in the fourth quarter of 2024, updated data from the Phase 1a arm of the AMPLIFY-7P trial expected in the first quarter of 2025, and interim analysis from the Phase 2 AMPLIFY-7P trial in the first quarter of 2025; 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; Elicio’s ability to successfully collaborate with existing collaborators or enter into new collaborations, and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of Elicio’s product candidates; Elicio’s commercialization, marketing and manufacturing capabilities and strategy; Elicio’s ability to identify additional products or product candidates with significant commercial potential; Elicio’s ability to advance ELI-002 outside of PDAC monotherapy and Elicio’s pipeline programs; developments and projections relating to Elicio’s competitors and our industry; the impact of government laws and regulations; Elicio’s ability to protect its intellectual property position; 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 29, 2024, as amended on April 29, 2024, 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. Investor Relations ContactBrian PiekosElicio TherapeuticsIR@elicio.com 857-209-0153
Phase 2ImmunotherapyPhase 1Clinical ResultFinancial Statement
100 Deals associated with ELI-002 7P
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Colorectal Cancer | Phase 2 | US | 14 Apr 2023 | |
| KRAS mutant pancreatic ductal adenocarcinoma | Phase 2 | US | 14 Apr 2023 |
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Clinical Result
Clinical Result
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1 | Colorectal Cancer | Pancreatic Cancer Circulating Tumor-Derived DNA Positive | CA 19-9 tumor marker | KRAS G12V | ... View more | 14 | ELI-002 7P 1.4 mg + Amph-CpG-7909 | ykmqfiducz(gxxuzgvmle) = pbvvftnenk kkumjqdfqc (tcyrpskxdw ) View more | Positive | 24 May 2024 | |
ELI-002 7P 4.9 mg + Amph-CpG-7909 | ykmqfiducz(gxxuzgvmle) = dnnhqkaico kkumjqdfqc (tcyrpskxdw ) View more |
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