Immuneering Reports Second Quarter 2022 Financial Results and Recent Business Highlights
August 10 2022 - 4:05PM
Immuneering Corporation (NASDAQ: IMRX), a biopharmaceutical company
using translational bioinformatics to advance a pipeline of product
candidates designed to benefit large populations of patients with
cancer and other diseases, today reported financial results for the
second quarter ended June 30, 2022 and provided recent business
highlights.
“We believe IMM-1-104 has great potential to benefit the many
cancer patients with tumors driven by KRAS or NRAS mutations,” said
Ben Zeskind, Ph.D., MBA, chief executive officer of Immuneering
Corporation. “We are thrilled to be gearing up to file our IND
for IMM-1-104, which remains on track to be filed this quarter, and
we expect to enroll the first patient in our planned Phase 1
clinical trial in the fourth quarter of 2022. To date, we have
generated strong preclinical results across a broad range of animal
tumor models including KRAS-G12C, KRAS-G12D, KRAS-G12S, KRAS-G12V,
NRAS-Q61R, and BRAF-V600E mutations. This compelling
preclinical data package demonstrates IMM-1-104’s potential as a
third generation MEK inhibitor to have broad activity that is
independent of the specific mutation activating the MAPK pathway.”
Corporate Highlights
- IMM-1-104 strongly inhibits tumor growth in an animal
model of KRAS-G12V Mutant Pancreatic Cancer: In May 2022,
Immuneering reported preclinical data at the ASCO 2022 meeting
titled “Head-to-head comparison of the dual-MEK inhibitor IMM-1-104
versus sotorasib or adagrasib in KRAS mutant pancreatic tumors” in
an online publication. In the Capan-2 PDAC KRAS-G12V xenograft
animal model, all doses and schedules of IMM-1-104 (75, 100,
150mg/kg BID p.o. or 150mg/kg QD p.o.) showed tumor growth
inhibition (TGI) of 49-84% after 21 days of treatment. Taken
together with IMM-1-104’s demonstrated preclinical activity across
KRAS-G12C, KRAS-G12D, KRAS-G12S, NRAS-Q61R and BRAF-V600E, this new
data in KRAS-G12V shows the potential to offer a unique advantage
in pancreatic cancer where a broad range of KRAS mutations
occur.
- IMM-1-104 translational modeling shows models sensitive
to IMM-1-104 were enriched for MAPK Driver Mutations: In
May 2022, Immuneering reported a second preclinical abstract at the
ASCO 2022 meeting entitled “Translational modeling for patients
with RAS mutant tumors: Profiling the dual-MEK inhibitor IMM-1-104
in a humanized 3D assay” in an online publication. IMM-1-104’s
pharmacological activity was profiled across 52 human tumor cell
lines spanning a variety of mutations in a 3D tumor growth assay
(3D-TGA). KRAS mutant pancreatic cancer and NRAS mutant melanoma
demonstrated broad sensitivity followed closely by KRAS mutant
NSCLC and KRAS mutant CRC to IMM-1-104 in the 3D-TGA, and thus are
included in Immuneering’s expected Phase 1/2a clinical trials.
Key Development Highlights
- IMM-1-104 IND submission expected this
quarter: Immuneering remains on track to file its IND for
IMM-1-104 this quarter.
- IMM-1-104 first patient enrolled expected in Q4
2022: Immuneering expects to enroll the first patient in
its Phase 1/2a clinical trial evaluating IMM-1-104 in advanced
solid tumors in patients with tumors driven by RAS mutations in the
fourth quarter of 2022.
- Second IND submission for
IMM-6-415 expected in 2023:
IMM-6-415, the company’s MEK-io program, is currently in
IND-enabling studies. Immuneering expects to file an IND
application for IMM-6-415 in 2023. IMM-6-415 is a dual-MEK
inhibitor that has drug-like properties optimized for immune
normalization and may enhance and/or expand clinical responses to
checkpoint inhibitors.
Second Quarter 2022 Financial
Highlights
- Cash Position: Cash and cash equivalents and marketable
securities as of June 30, 2022 were $128.1 million, compared with
$150.2 million as of December 31, 2021.
- Research and Development (R&D) Expenses: R&D expenses
for the second quarter ended June 30, 2022 were $8.0 million,
compared with $7.0 million for the same period in 2021. The
increase in R&D expenses was primarily attributable to higher
preclinical costs related to the company’s lead programs and
increased personnel to support ongoing research and development
activities.
- General and Administrative (G&A) Expenses: G&A expenses
for the second quarter ended June 30, 2022 were $3.7 million,
compared with $1.3 million for the same period of 2021. The
increase in G&A expenses was primarily attributable to an
increase in headcount to support the company’s business and to
costs related to operating as a public company.
- Net Loss: Net loss attributable to common stockholders was
$11.5 million, or $0.44 per share, for the second quarter ended
June 30, 2022, compared to $8.0 million, or $1.61 per share, for
the second quarter ended June 30, 2021.
2022 Financial Guidance
- Immuneering reiterates full year GAAP operating expenses to be
between $55.0 million and $60.0 million including estimated
non-cash stock-based compensation. Based on cash, cash equivalents
and marketable securities as of June 30, 2022, and current
operating plans, the company expects its cash runway to extend into
the third quarter of 2024.
About Immuneering
Corporation Immuneering aims to improve patient
outcomes by advancing a pipeline of product candidates designed to
benefit large populations of patients with cancer and other
diseases, developed using its translational
bioinformatics platform. Immuneering has more than a
decade of experience applying translational bioinformatics to
generate insights into drug mechanism of action and patient
treatment response. Building on this
experience, Immuneering's disease-agnostic discovery
platform enables the company to create product candidates
based on 1) biological insights that are both counterintuitive and
deeply rooted in data, and 2) novel
chemistry. Immuneering's lead product candidate,
IMM-1-104, aims to achieve pan-KRAS/NRAS activity that selectively
impacts cancer cells to a greater extent than healthy cells.
IMM-1-104 is designed to be a highly selective dual-MEK inhibitor
that further disrupts KSR to modulate the signaling dynamics of the
MAPK pathway by driving deep cyclic inhibition that deprives tumor
cells of the sustained proliferative signaling required for rapid
growth, while providing a cadenced, moderate level of signaling
sufficient to spare healthy cells. IMM-1-104 is being developed to
treat advanced solid tumors in patients harboring RAS mutations,
and is translationally guided
by Immuneering's proprietary, human-aligned 3D tumor
modeling platform combined with patient-aligned bioinformatics. In
addition to IMM-1-104, Immuneering
is evaluating its MEK-io product candidate,
IMM-6-415, in IND-enabling studies, and has five other
oncology programs in the discovery stage that are designed to
target components of the MAPK or mTOR pathway, as well as two
discovery stage neuroscience programs.
Forward-Looking
Statements This press release includes certain
disclosures that contain "forward-looking statements," including,
without limitation, statements regarding Immuneering’s expectations
regarding the sufficiency of Immuneering’s cash, cash equivalents
and marketable securities, its full year GAAP operating expenses
for 2022, the treatment potential of IMM-1-104 and IMM-6-415, the
timing of submission of the IND and commencement of clinical trials
for IMM-1-104 and IMM-6-415, and Immuneering’s ability to advance
its pipeline and further diversify its portfolio and make progress
towards its longstanding goal of creating better medicines for
cancer patients. Forward-looking statements are based on
Immuneering’s current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict.
Factors that could cause actual results to differ include, but are
not limited to, the risks inherent in oncology and neuroscience
drug development, including target discovery, target validation,
lead compound identification, lead compound optimization,
preclinical studies and clinical trials. These and other risks and
uncertainties are described more fully in the section titled "Risk
Factors" in Immuneering’s most recent Form 10-Q filed with the U.S.
Securities and Exchange Commission. Forward-looking statements
contained in this announcement are made as of this date, and
Immuneering
Corporate Contact: Rebecca Kusko,
Ph.D. Immuneering
Corporation rkusko@immuneering.com 617-500-8080
Investor Contact: Susan A. NoonanS.A.
Noonan Communicationssusan@sanoonan.com917-513-5303
IMMUNEERING CORPORATION
CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
94,419 |
|
|
$ |
660,040 |
|
|
$ |
278,117 |
|
|
$ |
1,408,240 |
|
Cost of
revenue |
|
|
47,933 |
|
|
|
318,601 |
|
|
|
138,778 |
|
|
|
727,763 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit |
|
|
46,486 |
|
|
|
341,439 |
|
|
|
139,339 |
|
|
|
680,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
7,981,075 |
|
|
|
6,991,965 |
|
|
|
17,031,517 |
|
|
|
12,382,985 |
|
General and administrative |
|
|
3,704,143 |
|
|
|
1,340,398 |
|
|
|
7,664,112 |
|
|
|
2,524,422 |
|
Amortization of intangible asset |
|
|
7,317 |
|
|
|
— |
|
|
|
15,420 |
|
|
|
— |
|
Total operating expenses |
|
|
11,692,535 |
|
|
|
8,332,363 |
|
|
|
24,711,049 |
|
|
|
14,907,407 |
|
Loss from operations |
|
|
(11,646,049 |
) |
|
|
(7,990,924 |
) |
|
|
(24,571,710 |
) |
|
|
(14,226,930 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
142,799 |
|
|
|
3,259 |
|
|
|
275,304 |
|
|
|
9,614 |
|
Other expense |
|
|
(24,053 |
) |
|
|
— |
|
|
|
(127,271 |
) |
|
|
- |
|
Net loss |
|
$ |
(11,527,303 |
) |
|
$ |
(7,987,665 |
) |
|
$ |
(24,423,677 |
) |
|
$ |
(14,217,316 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.44 |
) |
|
$ |
(1.61 |
) |
|
$ |
(0.93 |
) |
|
$ |
(2.87 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
26,386,343 |
|
|
|
4,954,553 |
|
|
|
26,372,787 |
|
|
|
4,952,352 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized losses from marketable securities |
|
|
(14,166 |
) |
|
|
— |
|
|
|
(132,552 |
) |
|
|
— |
|
Comprehensive
Loss |
|
$ |
(11,541,469 |
) |
|
$ |
(7,987,665 |
) |
|
$ |
(24,556,229 |
) |
|
$ |
(14,217,316 |
) |
IMMUNEERING CORPORATION
CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
87,937,479 |
|
|
$ |
74,888,145 |
|
Marketable securities, current |
|
|
40,163,875 |
|
|
|
74,311,203 |
|
Accounts receivable |
|
|
178,425 |
|
|
|
246,040 |
|
Prepaids and other current assets |
|
|
890,409 |
|
|
|
2,888,608 |
|
Total current assets |
|
|
129,170,188 |
|
|
|
152,333,996 |
|
|
|
|
|
|
|
|
Marketable securities,
non-current |
|
|
— |
|
|
|
996,560 |
|
Property and equipment, net |
|
|
985,007 |
|
|
|
807,223 |
|
Goodwill |
|
|
6,690,431 |
|
|
|
6,701,726 |
|
Intangible asset |
|
|
423,580 |
|
|
|
439,000 |
|
Right-of-use assets, net |
|
|
4,691,157 |
|
|
|
5,324,198 |
|
Other assets |
|
|
89,579 |
|
|
|
102,129 |
|
Total assets |
|
$ |
142,049,942 |
|
|
$ |
166,704,832 |
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,240,241 |
|
|
$ |
1,394,340 |
|
Accrued expenses |
|
|
2,226,687 |
|
|
|
3,965,447 |
|
Other liabilities, current |
|
|
47,213 |
|
|
|
— |
|
Lease liabilities, current |
|
|
286,374 |
|
|
|
274,039 |
|
Total current liabilities |
|
|
3,800,515 |
|
|
|
5,633,826 |
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
Other liabilities, non-current |
|
|
9,898 |
|
|
|
— |
|
Lease liabilities, non-current |
|
|
4,644,683 |
|
|
|
5,090,897 |
|
Total liabilities |
|
|
8,455,096 |
|
|
|
10,724,723 |
|
Commitments and contingencies
(Note 12) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized at June 30, 2022 and December
31, 2021, respectively; 0 shares issued or outstanding at June 30,
2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Class A common stock, $0.001 par
value, 200,000,000 shares authorized at June 30, 2022 and December
31, 2021; 26,392,299 and 26,320,199 shares issued and outstanding
at June 30, 2022 and December 31, 2021,
respectively |
|
|
26,392 |
|
|
|
26,320 |
|
Class B common stock, $0.001 par
value, 20,000,000 shares authorized at June 30, 2022 and December
31, 2021; 0 shares issued and outstanding at
June 30, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
217,447,080 |
|
|
|
215,276,186 |
|
Accumulated other comprehensive
loss |
|
|
(181,561 |
) |
|
|
(49,009 |
) |
Accumulated deficit |
|
|
(83,697,065 |
) |
|
|
(59,273,388 |
) |
Total stockholders' equity |
|
|
133,594,846 |
|
|
|
155,980,109 |
|
Total liabilities and stockholders' equity |
|
$ |
142,049,942 |
|
|
$ |
166,704,832 |
|
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