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 second quarter ended June 30, 2024,
and provided business updates.
“Our IMM-1-104 Phase 2a trial is enrolling well
across all arms, and we are on track to share initial data from
multiple arms this year,” said Ben Zeskind, Ph.D., Co-founder, and
Chief Executive Officer of Immuneering. “Each arm represents an
important unmet need, including first-line pancreatic cancer
patients, which are the focus of both our recent Fast Track
designation and multiple arms of the trial, including two arms
evaluating IMM-1-104 in combination with established chemotherapy
regimens. As we reported at AACR in April, these combinations in
animal models showed deeper and more durable tumor growth
inhibition than either treatment alone. We believe these arms are
also of interest because of the Phase 1 topline data we released in
March, in which IMM-1-104 monotherapy was observed to be
exceptionally well-tolerated and shrank at least one target lesion
in about half of pancreatic cancer patients. We are also evaluating
IMM-1-104 in monotherapy arms for patients with RAS mutant melanoma
and RAS mutant lung cancer, cancer types for which IMM-1-104 has
demonstrated encouraging preclinical data, along with a monotherapy
arm evaluating IMM-1-104 in first and second-line pancreatic cancer
patients. Finally, the Phase 1 dose escalation of IMM-6-415 is
progressing well in patients with advanced solid tumors with RAF or
RAS mutations, and we plan to report initial PK, PD and safety data
this year. All in all, we are looking forward to a data-rich second
half of 2024.”
Corporate Highlights
- FDA Fast Track Designation
for IMM-1-104 in First-line Pancreatic Cancer: In July
2024, the U.S. Food and Drug Administration (FDA) granted Fast
Track designation for IMM-1-104, as a first-line treatment for
patients with pancreatic ductal adenocarcinoma (PDAC).
- Preclinical Data Presented
at AACR Demonstrating that IMM-1-104 is Synergistic with
Chemotherapy in Pancreatic Cancer Models: In April 2024,
Immuneering presented preclinical data at the American Association
for Cancer Research (AACR) Annual Meeting, demonstrating that
combining IMM-1-104 with chemotherapies used in the treatment of
first-line pancreatic cancer yielded deeper and more durable tumor
growth inhibition than either treatment alone, which the Company
views as supportive of its ongoing Phase 2a clinical trial of
IMM-1-104 in RAS-mutated advanced or metastatic solid tumors.
Near-Term Milestone
Expectations
IMM-1-104
- Initial data from multiple arms of
the Phase 2a portion of the Company’s Phase 1/2a trial expected in
2H 2024.
IMM-6-415
- Initial pharmacokinetic (PK),
pharmacodynamic (PD) and safety data from the Phase 1 portion of
the Company’s Phase 1/2a trial expected in 2H 2024.
Second Quarter
2024 Financial Highlights
Cash Position: Cash, cash
equivalents and marketable securities as of June 30, 2024 were
$59.7 million, compared with $85.7 million as of
December 31, 2023.
Research and Development (R&D)
Expenses: R&D expenses for the second quarter of 2024,
were $10.7 million compared with $9.5 million for the second
quarter of 2023. The increase in R&D expenses 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 second quarter of 2024
were $4.3 million, compared with $4.0 million for the same period
of 2023. The increase in G&A is primarily attributed to an
increase in the Company’s stock-based compensation costs and
various other costs related to the general and administrative
functions.
Net Loss: Net loss attributable
to common stockholders was $14.1 million, or $0.47 per share, for
the second quarter ended June 30, 2024, compared to $12.2
million, or $0.43 per share, for the second quarter ended
June 30, 2023.
2024 Financial Guidance
Based on cash and cash equivalents as of
June 30, 2024, 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 with an initial aim to
develop a universal-RAS therapy. 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 trial in
patients with advanced solid tumors harboring RAS mutations.
IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor currently
in a Phase 1/2a trial 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 regarding: Immuneering’s plans to develop,
manufacture and commercialize its product candidates; the
sufficiency of the Company’s cash, cash equivalents, and cash
runway; its current operating plans; the treatment potential of
IMM-1-104 and IMM-6-415, alone or in combination with other agents,
including the ability to shrink tumors in a well-tolerated way
relative to other MAPK pathway inhibitors; the design, enrollment
criteria and progress of the Phase 1/2a clinical trials of
IMM-1-104 and IMM-6-415; the translation of preclinical data into
human clinical data; the potential advantages and effectiveness of
Immuneering’s clinical and preclinical candidates; and the pace of
enrollment and timing of reporting data from the Phase 2a portion
of the trial for IMM-1-104 and from the Phase 1 portion of the
trial for 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 (or timing thereof) to be
materially different from any future results, performance or
achievements (or timing thereof) 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 Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2024, and our other
reports filed with the U.S. Securities and Exchange Commission,
could cause actual results (or timing thereof) 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
Nugentgina@nugentcommunications.com
Investor Contact:Laurence
Watts619-916-7620laurence@newstreetir.com
IMMUNEERING CORPORATIONCONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Research and development |
|
10,651,958 |
|
|
|
9,452,711 |
|
|
|
21,854,372 |
|
|
|
19,663,637 |
|
General and administrative |
|
4,254,473 |
|
|
|
4,044,960 |
|
|
|
8,370,493 |
|
|
|
8,506,291 |
|
Amortization of intangible asset |
|
7,317 |
|
|
|
7,317 |
|
|
|
14,633 |
|
|
|
14,633 |
|
Total operating expenses |
|
14,913,748 |
|
|
|
13,504,988 |
|
|
|
30,239,498 |
|
|
|
28,184,561 |
|
Loss from operations |
|
(14,913,748 |
) |
|
|
(13,504,988 |
) |
|
|
(30,239,498 |
) |
|
|
(28,184,561 |
) |
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
Interest income |
|
826,104 |
|
|
|
1,166,047 |
|
|
|
1,630,988 |
|
|
|
1,997,321 |
|
Other income, net |
|
7,717 |
|
|
|
150,193 |
|
|
|
220,754 |
|
|
|
394,322 |
|
Net loss |
$ |
(14,079,927 |
) |
|
$ |
(12,188,748 |
) |
|
$ |
(28,387,756 |
) |
|
$ |
(25,792,918 |
) |
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.47 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.96 |
) |
|
$ |
(0.94 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
29,653,355 |
|
|
|
28,647,450 |
|
|
|
29,511,856 |
|
|
|
27,550,922 |
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
Unrealized gains (losses) from marketable securities |
|
1,084 |
|
|
|
(2,724 |
) |
|
|
778 |
|
|
|
27,902 |
|
Comprehensive
Loss |
$ |
(14,078,843 |
) |
|
$ |
(12,191,472 |
) |
|
$ |
(28,386,978 |
) |
|
$ |
(25,765,016 |
) |
IMMUNEERING CORPORATIONCONDENSED
CONSOLIDATED BALANCE
SHEETS(Unaudited) |
|
|
June 30, 2024 |
|
December 31, 2023 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
59,728,455 |
|
|
$ |
59,405,817 |
|
Marketable securities |
|
— |
|
|
|
26,259,868 |
|
Prepaids and other current assets |
|
3,957,220 |
|
|
|
3,417,984 |
|
Total current assets |
|
63,685,675 |
|
|
|
89,083,669 |
|
|
|
|
|
Property and equipment, net |
|
1,290,091 |
|
|
|
1,400,582 |
|
Goodwill |
|
6,690,431 |
|
|
|
6,690,431 |
|
Intangible asset, net |
|
365,047 |
|
|
|
379,680 |
|
Right-of-use assets, net |
|
3,827,943 |
|
|
|
3,995,730 |
|
Other assets |
|
1,228,088 |
|
|
|
1,034,446 |
|
Total assets |
$ |
77,087,275 |
|
|
$ |
102,584,538 |
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,622,237 |
|
|
$ |
2,111,666 |
|
Accrued expenses |
|
3,757,148 |
|
|
|
5,173,960 |
|
Other liabilities |
|
90,242 |
|
|
|
259,770 |
|
Lease liabilities |
|
311,459 |
|
|
|
300,107 |
|
Total current liabilities |
|
6,781,086 |
|
|
|
7,845,503 |
|
|
|
|
|
Long-term liabilities: |
|
|
|
Lease liabilities, net of current portion |
|
4,000,554 |
|
|
|
4,162,852 |
|
Total liabilities |
|
10,781,640 |
|
|
|
12,008,355 |
|
Commitments and contingencies
(Note 10) |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized at June 30, 2024 and
December 31, 2023; 0 shares issued or outstanding at
June 30, 2024 and December 31, 2023 |
|
— |
|
|
|
— |
|
Class A common stock, $0.001 par
value, 200,000,000 shares authorized at June 30, 2024 and
December 31, 2023; 29,653,355 and 29,271,629 shares issued and
outstanding at June 30, 2024 and December 31, 2023,
respectively |
|
29,653 |
|
|
|
29,272 |
|
Class B common stock, $0.001 par
value, 20,000,000 shares authorized at June 30, 2024 and
December 31, 2023; 0 shares issued and outstanding at
June 30, 2024 and December 31, 2023 |
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
257,922,316 |
|
|
|
253,806,267 |
|
Accumulated other comprehensive
loss |
|
— |
|
|
|
(778 |
) |
Accumulated deficit |
|
(191,646,334 |
) |
|
|
(163,258,578 |
) |
Total stockholders' equity |
|
66,305,635 |
|
|
|
90,576,183 |
|
Total liabilities and stockholders' equity |
$ |
77,087,275 |
|
|
$ |
102,584,538 |
|
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