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,
2023, and provided recent business highlights.
“2023 was a momentous year for Elicio with the
completion of a successful reverse merger, presenting clinical data
from our first-in-human trial and advancing ELI-002 into a
randomized Phase 2 trial,” said Robert Connelly, Elicio’s Chief
Executive Officer. “Already in 2024 we have built on 2023’s
progress with our Phase 1a clinical data being published in Nature
Medicine and announcing the first patients were dosed in the
randomized Phase 2 trial. We continue to focus on advancing our
lead cancer vaccine candidate, ELI-002, and the progression of our
randomized Phase 2 study as a monotherapy for patients with PDAC.
We have an exciting year ahead as we expect to share data from the
AMPLIFY-7P Phase 1 study of ELI-002 7P in the second quarter.”
Corporate Updates
AMPLIFY-7P Phase 1a:
- Completed
enrollment of 14 patients in the third quarter of 2023 with initial
clinical data for ELI-002 7P expected in the second quarter of
2024.
- The
independent data monitoring committee completed the safety review
of ELI-002 7P Phase 1 trial patients and confirmed the recommended
Phase 2 trial dose.
AMPLIFY-7P Phase 2:
- First patients
dosed in a randomized Phase 2 study of ELI-002 7P, an
investigational therapeutic cancer vaccine, administered as an
adjuvant monotherapy treatment for patients with KRAS-mutated
pancreatic ductal adenocarcinoma (“PDAC”).
AMPLIFY-201 Phase 1a:
- Data from the first-in-human study
of ELI-002 2P published in Nature Medicine shows:
- The data were
as of September 6, 2023, based on 25 patients with solid tumors (20
pancreatic, 5 colorectal) who were positive for minimal residual
mKRAS disease after locoregional treatment.
- Direct ex vivo
mKRAS-specific T cell responses were observed in 21/25 patients
(84%; 59% both CD4+ and CD8+).
- Tumor
biomarker responses were observed in 21/25 patients (84%) and
biomarker clearance in 6/25 patients, as determined by
tumor-informed circulating tumor DNA (24%; 3 pancreatic, 3
colorectal).
- At 8.5 months
median follow-up the median RFS of the 25-patient cohort was 16.33
months.
- Efficacy
correlated with T cell response (≥ versus < median: 12.75-fold
over baseline):
- Median tumor
biomarker reduction was -76.0% compared to -10.2% in above versus
below median T cell responders, respectively (p<0.0014).
- Median RFS was
not reached compared to 4.01 months in above versus below median T
cell responders, respectively (HR 0.14, 95% CI 0.03 to 0.63,
p=0.0167).
- Patients with
greater than median T cell response had an 86% reduction in the
risk of progression or death.
- The
association of RFS with T cell response was not correlated to
baseline prognostic variables including tumor stage, recovery from
prior cytotoxic therapy as assessed by absolute neutrophil count or
immune system subsets such as %CD4+ or %CD8+ of CD3+
lymphocytes.
- RFS was
shorter in patients who began treatment with a low absolute
lymphocyte count.
- No safety
concerns were identified, and no dose limiting toxicities and no ≥
grade 3 treatment related adverse events were observed.
2023 Financial Results
R&D expense for 2023 was $23.8 million,
compared to $18.1 million for 2022. The increase in R&D expense
was primarily due to increased manufacturing and clinical trial
expenses as Elicio initiated the AMPLIFY-7P Phase 1a study and
generated a clinical trial product to supply the ongoing Phase 2
trial.
G&A expense for 2023 was $11.9 million,
compared to $5.6 million 2022. The increase in G&A expense was
primarily attributable to professional fees, personnel expenses,
and insurance associated with operating as a public company.
Net loss for 2023 was $35.2 million, compared to
$28.2 million for 2022. Net loss per share for 2023 was $6.96
compared to $89.27 for 2022. The reduction in net loss
per share was primarily due to an increase in weighted average
common shares outstanding as a result of the reverse merger with
Angion Biomedica Corp. in June 2023.
Cash and cash equivalents as of December 31,
2023, were $12.9 million, compared to $6.2 million as of December
31, 2022.
|
ELICIO THERAPEUTICS, INC.Condensed Consolidated
Statements of Operations and Comprehensive Loss (unaudited)(in
thousands, except share and per share amounts) |
|
|
|
|
|
Year Ended December 31, |
|
|
2023 |
|
2022 |
Operating
expenses: |
|
|
|
|
Research and development |
|
$ |
23,849 |
|
|
$ |
18,103 |
|
General and administrative |
|
|
11,896 |
|
|
|
5,630 |
|
Total operating expenses |
|
|
35,745 |
|
|
|
23,733 |
|
Loss from
operations |
|
|
(35,745 |
) |
|
|
(23,733 |
) |
Total other income
(expense) |
|
|
550 |
|
|
|
(4,475 |
) |
Net Loss |
|
|
(35,195 |
) |
|
|
(28,208 |
) |
Other comprehensive
income: |
|
|
|
|
Foreign currency translation adjustment |
|
|
(197 |
) |
|
|
— |
|
Comprehensive
loss |
|
$ |
(35,392 |
) |
|
$ |
(28,208 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(6.96 |
) |
|
$ |
(89.27 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
5,056,225 |
|
|
|
315,998 |
|
|
ELICIO THERAPEUTICS, INC.Condensed Consolidated
Balance Sheets(unaudited)(in thousands) |
|
|
December 31,2023 |
|
December 31,2022 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
12,894 |
|
$ |
6,156 |
Other current assets |
3,454 |
|
4,561 |
Total current assets |
16,348 |
|
10,717 |
Other assets |
10,798 |
|
11,947 |
Total
assets |
$ |
27,146 |
|
$ |
22,664 |
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Current liabilities |
$ |
9,766 |
|
$ |
6,868 |
Long-term liabilities |
6,007 |
|
6,881 |
Total
liabilities |
15,773 |
|
13,749 |
|
|
|
|
Total
stockholders’ equity (deficit) |
11,373 |
|
8,915 |
|
|
|
|
Total
liabilities and stockholders' equity |
$ |
27,146 |
|
$ |
22,664 |
|
|
|
|
|
|
About Elicio Therapeutics
Elicio Therapeutics is a clinical-stage
biotechnology company developing a pipeline of novel
immunotherapies for the treatment of cancer. By combining expertise
in immunology and immunotherapy, Elicio is engineering
investigational Amphiphile (“AMP”) immunotherapies intended to
precisely target and fully engage the lymph nodes, the site in our
bodies where the immune response is orchestrated. Elicio is
engineering lymph node-targeted AMPlifiers, immunomodulators,
adjuvants, and vaccines for an array of aggressive cancers.
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 the
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 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 Phase 2
randomized trial in PDAC in the fourth quarter of 2024; the timing
of the availability of data from Elicio’s clinical trials,
including data from the AMPLIFY-7P Phase 1 study of ELI-002 7P
expected in the second 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 that is expected to be 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 Politi LifeSci
Communications kpoliti@lifescicomms.com646-876-4783
Investor Relations ContactHeather
DiVecchiaElicio TherapeuticsIR@elicio.com 857-209-0153
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