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 first quarter
ended March 31, 2024, and provided recent corporate and
clinical updates.
“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.”
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice
President, Head of Research and Development, and Chief Medical
Officer, added, “We have continued to analyze and publish data from
our first-in-human study characterizing the robust and
differentiated T cell response generated by ELI-002. Building on
the magnitude of the KRAS-specific T cell response including both
CD4+ and CD8+ recent data presented at AACR, we also demonstrated
that ELI-002’s mechanism of action includes antigen-spreading,
where personal neoantigens are targeted alongside the KRAS-specific
response that may enhance clinical activity.”
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 $7.6 million,
compared to $5.5 million for the first 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
trial and initiation of the AMPLIFY-7P Phase 2 trial.
G&A expense for the first quarter of 2024 was $2.7 million,
compared to $2.3 million for the first quarter of 2023. The
increase in G&A expense was primarily attributable to
professional fees, personnel expense and insurance associated with
operating as a public company.
Net loss for the first quarter of 2024 was $11.8 million,
compared to $8.0 million for the first quarter of 2023. Net loss
per share for the first quarter of 2024 was $1.15 compared to
$24.77 for the first quarter of 2023.
Cash and cash equivalents as of March 31, 2024, were $11.9
million, compared to $12.9 million as of December 31, 2023.
ELICIO THERAPEUTICS, INC.Condensed Consolidated
Statements of Operations and Comprehensive Loss(in thousands,
except share and per share amounts)(unaudited) |
|
|
|
|
Three Months Ended March 31, |
|
|
|
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 |
|
|
ELICIO THERAPEUTICS, INC.Condensed Consolidated
Balance Sheets(in thousands)(unaudited) |
|
|
March 31,2024 |
|
December 31,2023 |
|
|
|
|
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 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. The Company’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.
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
June 2024, interim analysis from the Phase 2 AMPLIFY-7P trial in
the first quarter of 2025, and updated immunogenicity and relapse
free survival data from the AMPLIFY-201 trial in the fourth quarter
of 2024; 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, 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.
Media ContactKristin PolitiLifeSci
Communicationskpoliti@lifescicomms.com646-876-4783
Investor Relations ContactHeather
DiVecchiaElicio TherapeuticsIR@elicio.com 857-209-0153
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