Immuneering Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates
March 01 2024 - 8:00AM
Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology
company seeking to develop and commercialize universal-RAS/RAF
medicines for broad populations of cancer patients, today reported
financial results for the fourth quarter and full year ended
December 31, 2023, and provided recent business updates.
“We look forward to sharing topline data from
the Phase 1 portion of the Phase 1/2a trial of IMM-1-104 this
month. IMM-1-104’s unique deep cyclic inhibition mechanism was
designed for broad universal-RAS activity and a differentiated
safety profile. We believe this update will provide important
insights on the primary and secondary endpoints of the Phase 1
portion of the trial, and is a key milestone that builds on the
substantial progress made in 2023,” said Ben Zeskind, Chief
Executive Officer, Immuneering. “Importantly, 2024 is shaping up to
be even more exciting, as we look forward to data readouts from
multiple arms of the expanded Phase 2a portion of our Phase 1/2a
trial of IMM-1-104, and launch our Phase 1/2a trial of
IMM-6-415.”
Full Year 2023 and Subsequent Corporate
Highlights
- Topline data from the Phase 1 portion of the Phase 1/2a
clinical trial of IMM-1-104 expected in March
2024: The update is expected to include data on the
primary and secondary endpoints of the Phase 1 portion of the Phase
1/2a trial (tolerability, candidate RP2D, and PK), as well as PD,
circulating tumor DNA (ctDNA), and initial clinical activity
data.
- Dosing of the first patient in the expanded Phase 2a
portion of the Phase 1/2a clinical trial of IMM-1-104 expected in
March 2024: The clinical development plan for the trial
was expanded in November 2023 to include 5 arms and additional
clinical sites and investigators.
- The Phase 2a portion of the trial is evaluating IMM-1-104 as a
single-agent in approximately 90 patients across three arms:
- IMM-1-104 monotherapy in patients with pancreatic ductal
adenocarcinoma (PDAC) in the first- or second-line setting
(n=30).
- IMM-1-104 monotherapy in RAS-mutant melanoma in the second- or
third-line setting after patients have received immunotherapy
(n=30), or in the first line setting for patients who are not
candidates for existing therapies.
- IMM-1-104 monotherapy in RAS-mutant non-small cell lung cancer
(NSCLC) in the second- or third-line setting (n=30).
- The Phase 2a combination portion of the trial is evaluating
approximately 60 PDAC patients in the first-line setting across two
arms:
- IMM-1-104 in combination with mFOLFIRINOX (n=30).
- IMM-1-104 in combination with modified
gemcitabine/nab-paclitaxel (n=30).
- The first patient in the expanded Phase 2a portion of the Phase
1/2a study is expected to be dosed in March 2024, with initial data
from multiple arms expected in 2024.
- Received FDA Fast Track designation for IMM-1-104 in
pancreatic cancer: In February 2024, Immuneering announced
that the U.S. Food and Drug Administration (FDA) granted Fast Track
Designation for its lead clinical-stage program, IMM-1-104, for the
treatment of patients with pancreatic ductal adenocarcinoma (PDAC)
who have failed one line of treatment. IMM-1-104 is designed to
provide universal-RAS activity through deep cyclic inhibition of
the MAPK pathway with once-daily oral dosing.
- Dosing of the first patient in the Phase 1/2a clinical
trial of IMM-6-415 expected in March 2024: The Phase 1
portion of the open-label trial is designed to evaluate the safety,
tolerability, PK, and PD of IMM-6-415, as well as identify a
candidate RP2D. The Phase 2a portion of the trial will further
evaluate safety, tolerability, pharmacokinetics and clinical
activity of IMM-6-415, all in patients with advanced solid tumors
harboring RAF or RAS mutations. The Phase 1 portion of the clinical
trial, which may enroll up to approximately 60 patients, will
evaluate IMM-6-415 following a Bayesian mTPI-2 escalation design.
Following the Company’s selection of the RP2D candidate, the
Company expects to conduct a Phase 2a dose expansion phase in
approximately 180 patients in multiple dose expansion arms.
- Presented preclinical data demonstrating encouraging
anti-tumor activity for IMM-1-104 and IMM-6-415: In
October 2023, Immuneering presented preclinical data at
AACR-NCI-EORTC. Expanded benchmarking of IMM-1-104 as a single
agent across 193 patient-aligned models in humanized 3D-tumor
growth assays demonstrated high sensitivity in a wide range of
MAPK-driven tumors, including melanoma, pancreatic cancer and lung
cancer. IMM-1-104 in combination with gemcitabine or paclitaxel
drove enhanced anti-tumor activity in humanized 3D-tumor growth
assays across multiple pancreatic cancer models. Benchmarking of
IMM-6-415 as a single agent across more than 60 patient-aligned
models in humanized 3D-tumor growth assays demonstrated high
sensitivity in a wide range of MAPK-driven tumors, including models
of RAS and RAF mutant disease. IMM-6-415 in combination with
encorafenib drove deeper regressions and superior durability
compared to binimetinib plus encorafenib in a head-to-head study in
animal models of RAF mutant melanoma and colorectal cancer.
- Completed dose escalation of the Phase 1 portion of the
Phase 1/2a clinical trial evaluating IMM-1-104 for RAS-mutant,
advanced solid tumors: In June 2023, the trial’s Safety
Review Committee (SRC) completed its evaluation and observed that
doses up to and including 320 mg once daily were tolerated with no
dose-limiting toxicities. The dose evaluation portion of the trial
was designed to evaluate two dosing cohorts of approximately 20
patients each at an oral dose of 240mg or 320mg once daily.
- Raised $30 million in an underwritten
offering: In April 2023, Immuneering completed an
underwritten offering of 2,727,273 shares of its Class A common
stock at an offering price of $11.00 per share. The aggregate net
proceeds received by the Company from the offering were $28.2
million, after deducting underwriting discounts and commissions,
but before deducting offering expenses payable by Immuneering.
- Reported positive initial Phase 1 PK, PD, and safety
data for IMM-1-104: In April 2023, Immuneering presented
initial Phase 1 PK, PD, and safety data for IMM-1-104 at the
American Association for Cancer Research (AACR) annual meeting.
IMM-1-104 achieved significant levels of PK Cmax, demonstrated a
half-life of approximately two hours, as predicted, and was well
tolerated with no dose-limiting toxicities. These data support the
potential of IMM-1-104 to drive deep cyclic inhibition of the MAPK
pathway.
Near-Term Milestone Expectations
IMM-1-104
- Topline data from the Phase 1 portion of the Phase 1/2a
clinical trial expected in March 2024. The update is expected to
include data on the primary and secondary endpoints of the Phase 1
portion of the Phase 1/2a study (tolerability, candidate RP2D, and
PK), as well as PD, ctDNA, and initial clinical activity data.
- First patient expected to be dosed in the Phase 2a portion of
the Phase 1/2a trial in March 2024.
- Initial data from multiple Phase 2a arms expected in 2024.
- Additional trial updates expected on a periodic basis.
IMM-6-415
- First patient expected to be dosed in the Phase 1 portion of
the Phase 1/2a trial in March 2024.
Fourth Quarter and Full
Year 2023 Financial
Highlights
- Cash Position:
Cash, cash equivalents and marketable securities as of
December 31, 2023 were $85.7 million, compared with $105.5
million as of December 31, 2022.
- Research and Development
(R&D) Expenses: R&D expenses for the fourth
quarter of 2023 were $11.9 million compared with $9.9 million for
the fourth quarter of 2022. Full year 2023 R&D expenses were
$41.6 million compared to $36.3 million for full year 2022. The
increase in R&D expenses from both periods of 2023 was
primarily attributable to higher clinical costs related to the
Company’s lead program and increased personnel to support ongoing
research and development activities.
- General and Administrative
(G&A) Expenses: G&A expenses for the fourth
quarter of 2023 were $4.4 million compared with $4.1 million for
the same period of 2022. Full year 2023 G&A expenses were $16.8
million compared to $15.6 million for full year 2022. The increase
in G&A expenses for both periods of 2023 was primarily
attributable to an increase in headcount in the Company’s general
and administrative functions to support the business, and costs
related to operating as a public company.
- Net Loss: Net loss
attributable to common stockholders was $15.1 million, or $0.52 per
share, for the quarter ended December 31, 2023, compared to $13.2
million, or $0.50 per share, for the quarter ended December 31,
2022. Net loss attributable to common stockholders for full year
2023 was $53.5 million, or $1.88 per share compared to $50.5
million, or $1.91 per share, for full year 2022.
2024 Financial
Guidance
- Based on cash, cash equivalents and
marketable securities, as of December 31, 2023, and current
operating plans, the Company expects its cash runway to be
sufficient to fund operations into the second half of 2025.
About Immuneering
Corporation
Immuneering is a clinical-stage oncology company
seeking to develop and commercialize universal-RAS/RAF medicines
for broad populations of cancer patients. The Company aims to
achieve universal activity through deep cyclic inhibition of the
MAPK pathway, impacting cancer cells while sparing healthy cells.
Immuneering’s lead product candidate, IMM-1-104, is an oral,
once-daily deep cyclic inhibitor currently in a Phase 1/2a study in
patients with advanced solid tumors harboring RAS mutations.
IMM-6-415 is an oral, twice-daily deep cyclic inhibitor and will be
evaluated in a Phase 1/2a study in patients with advanced solid
tumors harboring RAS or RAF mutations. The Company’s development
pipeline also includes several early-stage programs. For more
information, please visit www.immuneering.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including within the meaning of the Private Securities
Litigation Reform Act of 1995. All statements contained in this
press release that do not relate to matters of historical fact
should be considered forward-looking statements, including without
limitation statements concerning: the expected design, timing,
enrollment and advancement of, and data results from, preclinical
studies and clinical trials involving our product candidates; the
potential of our product candidates to be used as monotherapies and
/ or in combination with other therapeutic agents, including to
treat RAS or RAF mutant diseases; our expected cash runway; and the
clinical development of IMM-1-104 and IMM-6-415.
These forward-looking statements are based on
management’s current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not
limited to, the following: the risks inherent in oncology drug
research and development, including target discovery, target
validation, lead compound identification, and lead compound
optimization; we have incurred significant losses, are not
currently profitable and may never become profitable; our projected
cash runway; our need for additional funding; our unproven approach
to therapeutic intervention; our ability to address regulatory
questions and the uncertainties relating to regulatory filings,
reviews and approvals; the lengthy, expensive, and uncertain
process of clinical drug development, including potential delays in
or failure to obtain regulatory approvals; our reliance on third
parties and collaborators to conduct our clinical trials,
manufacture our product candidates, and develop and commercialize
our product candidates, if approved; failure to compete
successfully against other drug companies; protection of our
proprietary technology and the confidentiality of our trade
secrets; potential lawsuits for, or claims of, infringement of
third-party intellectual property or challenges to the ownership of
our intellectual property; our patents being found invalid or
unenforceable; costs and resources of operating as a public
company; and unfavorable or no analyst research or reports.
These and other important factors discussed
under the caption “Risk Factors” in our Annual Report on Form 10-K
for the annual period ended December 31, 2023, and our other
reports filed with the United States Securities and Exchange
Commission, could cause actual results to differ materially from
those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management's estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, except as required by law, we disclaim any
obligation to do so, even if subsequent events cause our views to
change. These forward-looking statements should not be relied upon
as representing our views as of any date subsequent to the date of
this press release.
Media Contact:Gina NugentNugent
Communications617-460-3579gina@nugentcommunications.com
Investor Contacts:Laurence WattsGilmartin
Group619-916-7620laurence@gilmartinir.com
or
Kiki Patel, PharmDGilmartin Group
332-895-3225kiki@gilmartinir.com
IMMUNEERING CORPORATION |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(Unaudited) |
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
Revenue |
$ |
— |
|
|
$ |
456 |
|
|
$ |
— |
|
|
$ |
316,952 |
|
Cost of
revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
158,122 |
|
|
|
|
|
|
|
|
|
Gross
profit |
|
— |
|
|
|
456 |
|
|
|
— |
|
|
|
158,830 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Research and development |
|
11,910,183 |
|
|
|
9,871,761 |
|
|
|
41,624,018 |
|
|
|
36,267,116 |
|
General and
administrative |
|
4,384,488 |
|
|
|
4,106,385 |
|
|
|
16,759,602 |
|
|
|
15,606,529 |
|
Amortization of intangible
asset |
|
7,317 |
|
|
|
7,317 |
|
|
|
29,267 |
|
|
|
30,053 |
|
Total operating expenses |
|
16,301,988 |
|
|
|
13,985,463 |
|
|
|
58,412,887 |
|
|
|
51,903,698 |
|
Loss from
operations |
|
(16,301,988 |
) |
|
|
(13,985,007 |
) |
|
|
(58,412,887 |
) |
|
|
(51,744,868 |
) |
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
Interest income |
|
754,144 |
|
|
|
516,167 |
|
|
|
3,606,996 |
|
|
|
1,014,456 |
|
Other income, net |
|
464,352 |
|
|
|
223,278 |
|
|
|
1,334,269 |
|
|
|
216,844 |
|
Net loss |
$ |
(15,083,492 |
) |
|
$ |
(13,245,562 |
) |
|
$ |
(53,471,622 |
) |
|
$ |
(50,513,568 |
) |
|
|
|
|
|
|
|
|
Net
loss per share attributable to common stockholders, basic and
diluted |
|
(0.52 |
) |
|
|
(0.50 |
) |
|
|
(1.88 |
) |
|
|
(1.91 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
29,269,842 |
|
|
|
26,406,933 |
|
|
|
28,416,558 |
|
|
|
26,386,864 |
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
Unrealized gain from
marketable securities |
|
(6,385 |
) |
|
|
112,353 |
|
|
|
29,342 |
|
|
|
18,889 |
|
Comprehensive
Loss |
$ |
(15,089,877 |
) |
|
$ |
(13,133,209 |
) |
|
$ |
(53,442,280 |
) |
|
$ |
(50,494,679 |
) |
IMMUNEERING CORPORATION |
CONSOLIDATED BALANCE SHEETS |
|
|
December 31,2023 |
|
December 31,2022 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
59,405,817 |
|
|
$ |
72,636,886 |
|
Marketable securities, current |
|
26,259,868 |
|
|
|
32,887,970 |
|
Accounts receivable |
|
— |
|
|
|
12,417 |
|
Prepaids and other current assets |
|
3,417,984 |
|
|
|
3,209,536 |
|
Total current assets |
|
89,083,669 |
|
|
|
108,746,809 |
|
|
|
|
|
Property and equipment,
net |
|
1,400,582 |
|
|
|
1,369,608 |
|
Goodwill |
|
6,690,431 |
|
|
|
6,690,431 |
|
Intangible asset, net |
|
379,680 |
|
|
|
408,947 |
|
Right-of-use assets, net |
|
3,995,730 |
|
|
|
4,407,785 |
|
Other assets |
|
1,034,446 |
|
|
|
743,703 |
|
Total assets |
$ |
102,584,538 |
|
|
$ |
122,367,283 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,111,666 |
|
|
$ |
3,154,557 |
|
Accrued expenses |
|
5,173,960 |
|
|
|
4,500,993 |
|
Other liabilities |
|
259,770 |
|
|
|
19,796 |
|
Lease liabilities |
|
300,107 |
|
|
|
378,723 |
|
Total current liabilities |
|
7,845,503 |
|
|
|
8,054,069 |
|
|
|
|
|
Long-term liabilities: |
|
|
|
Lease liabilities, net of current portion |
|
4,162,852 |
|
|
|
4,462,959 |
|
Total liabilities |
|
12,008,355 |
|
|
|
12,517,028 |
|
Commitments and contingencies
(Note 11) |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
December 31, 2023 and December 31, 2022; 0 shares issued
or outstanding at December 31, 2023 and December 31,
2022 |
|
— |
|
|
|
— |
|
Class A common stock, $0.001
par value, 200,000,000 shares authorized at December 31, 2023
and December 31, 2022; 29,271,629 and 26,418,732 shares issued
and outstanding at December 31, 2023 and December 31,
2022, respectively |
|
29,272 |
|
|
|
26,419 |
|
Class B common stock, $0.001
par value, 20,000,000 shares authorized at December 31, 2023
and December 31, 2022; 0 shares issued and outstanding at
December 31, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
Additional paid-in
capital |
|
253,806,267 |
|
|
|
219,640,912 |
|
Accumulated other
comprehensive loss |
|
(778 |
) |
|
|
(30,120 |
) |
Accumulated deficit |
|
(163,258,578 |
) |
|
|
(109,786,956 |
) |
Total stockholders' equity |
|
90,576,183 |
|
|
|
109,850,255 |
|
Total liabilities and stockholders' equity |
$ |
102,584,538 |
|
|
$ |
122,367,283 |
|
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