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)
Assets |
June 30, 2024 |
|
December 31, 2023 |
Cash and cash equivalents |
$ |
3,425 |
|
$ |
12,894 |
Other current assets |
3,264 |
|
3,454 |
Total current assets |
6,689 |
|
16,348 |
Other assets |
9,061 |
|
10,798 |
Total
assets |
$ |
15,750 |
|
$ |
27,146 |
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities |
$ |
7,585 |
|
$ |
9,755 |
Long-term liabilities |
9,817 |
|
6,018 |
Total
liabilities |
17,402 |
|
15,773 |
Total stockholders’
equity (deficit) |
(1,652) |
|
11,373 |
Total 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
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