Immuneering Reports Third Quarter 2022 Financial Results and Recent Business Highlights
November 10 2022 - 9:00AM
Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical
company that aims to create medicines for all patients with solid
tumors driven by RAS mutations and other MAPK pathway activation
events, today reported financial results for the third quarter
ended September 30, 2022, and provided recent business
highlights.
“The third quarter was a turning point for Immuneering as we
submitted and cleared our first IND. Our Phase 1/2a trial for
IMM-1-104 is now recruiting in what we believe is the first
all-comers RAS clinical trial conducted to date,” said Ben Zeskind,
Chief Executive Officer of Immuneering Corporation. “Cancer
patients need new treatment options, regardless of the specific
mutations in KRAS, NRAS, or HRAS that might be driving their
tumors. IMM-1-104 has shown pan-RAS activity in preclinical studies
with good tolerability. The conventional wisdom has been that a
pan-RAS approach makes it difficult to avoid hitting wild-type RAS
in healthy cells, but IMM-1-104’s novel deep cyclic inhibition
mechanism aims to focus the therapeutic activity against RAS-driven
malignant cells with the goal of largely sparing healthy
cells.”
Dr. Zeskind continued, “Today, we also shared promising
preclinical data on our second program IMM-6-415 at the 37th Annual
Meeting of SITC. IMM-6-415 is designed to target RAF and RAS mutant
tumors as monotherapy and enhance therapeutic activity in select
drug-drug combinations, including checkpoint inhibitors. We are
very encouraged by this data and look forward to completing ongoing
IND-enabling studies and expect to submit an IND for IMM-6-415 in
Q4 2023.”
Corporate Highlights
- IND Cleared for Phase 1/2a Trial of IMM-1-104 in
September 2022; Clinical Trial (NCT05585320) is Recruiting, and
First Patient is Expected to be Dosed this Quarter. On
September 30, 2022, the company announced its IND application for
IMM-1-104 had been cleared. The Phase 1/2a clinical trial is now
recruiting and the company intends to dose its first patient this
quarter. The Phase 1/2a clinical trial will interrogate IMM-1-104's
safety, tolerability, pharmacokinetics, pharmacodynamics and
preliminary anti-cancer activity for the treatment of advanced RAS
mutant solid tumors. Five internationally recognized clinical sites
in the United States will evaluate IMM-1-104 following a Bayesian
mTPI-2 escalation design in order to determine a Recommended Phase
2 Dose. Following the Phase 1 portion, the company anticipates a
dose expansion Phase 2a in RAS mutated pancreatic, melanoma,
colorectal and lung cancers.
- IMM-6-415 Presentation at SITC. Today,
Immuneering presented data on its second program, IMM-6-415, during
a poster session at the 37th Annual Meeting of the Society for
Immunotherapy of Cancer (SITC). IMM-6-415 demonstrates promising
preclinical activity as a single agent in RAF and RAS mutant tumors
and enhances PD1 and CTLA4 checkpoint blockade. IMM-6-415 is
designed to provide deep cyclic inhibition of the MAPK pathway with
an accelerated cadence relative to the once-daily dosing of
IMM-1-104.
- Chief People Officer Appointed. In October
2022, the company announced the appointment of Leah R. Neufeld to
the newly created Chief People Officer position. Ms. Neufeld brings
decades of experience in life sciences as well as human resources
and will join the senior leadership team in continuing to make the
company a great place for the all-star team of Immuneers to work
and grow, while also helping to add new talent as the company
advances a robust pipeline of novel product candidates.
Key Development Highlights
- IMM-1-104 IND submission cleared in Q3 2022:
The IND for IMM-1-104 cleared in under 30 days.
- First patient in Phase 1/2a trial expected to be dosed
this quarter: Immuneering expects to dose the first
patient in its Phase 1/2a clinical trial evaluating IMM-1-104 in
advanced solid tumors with RAS mutations this quarter.
- Second IND submission for IMM-6-415 expected in Q4
2023: IMM-6-415 is currently in
IND-enabling studies. Immuneering expects to file an IND
application for IMM-6-415 in Q4 2023.
Third Quarter 2022 Financial
Highlights
- Cash Position: Cash and cash equivalents and marketable
securities as of September 30, 2022, were $117.2 million, compared
with $150.2 million as of December 31, 2021.
- Research and Development (R&D) Expenses: R&D expenses
for the third quarter ended September 30, 2022, were $9.4 million,
compared with $6.2 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 third quarter ended September 30, 2022, were $3.8 million,
compared with $2.6 million for the same period of 2021. The
increase in G&A expenses was primarily attributable to an
increase in headcount in the company’s general and administrative
functions to support its business and to costs related to operating
as a public company.
- Net Loss: Net loss attributable to common stockholders was
$12.8 million, or $0.49 per share, for the third quarter ended
September 30, 2022, compared to $8.5 million, or $0.47 per share,
for the third quarter ended September 30, 2021.
2022 Financial Guidance
- Immuneering expects full year GAAP operating expenses to be
between $53.0 million and $56.0 million including estimated
non-cash stock-based compensation. This compares to previous
guidance of between $55.0 million and $60.0 million. The difference
is primarily due to the timing of certain R&D expenses. Based
on cash, cash equivalents and marketable securities as of September
30, 2022, and current operating plans, the company continues to
expect its cash runway to extend into the third quarter of
2024.
About Immuneering Corporation
Immuneering aims to create medicines for all patients with
solid tumors driven by RAS mutations and other MAPK pathway
activation events. 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-RAS activity that selectively
impacts cancer cells to a greater extent than healthy cells.
IMM-1-104 is designed to be a highly selective third generation
dual MEK inhibitor that modulates 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, normalized level of signaling
designed 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 currently evaluating IMM-6-415
in IND-enabling studies. The earlier Immuneering drug discovery
pipeline includes five additional oncology programs as well as
two 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 treatment potential of IMM-1-104 and IMM-6-415, the
timing of enrollment and dosing of the first patient in the Phase
1/2a clinical trial for IMM-1-104, the design, enrollment criteria
and conduct of the Phase 1/2a clinical trial, the timing of
submission of the IND and commencement of clinical trials for
IMM-6-415, that the Phase 1/2a trial of IMM-1-104 is believed to be
the first all-comers RAS trial conducted to date, statements
regarding Immuneering’s financial guidance 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 research and 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 undertakes no duty to update
such information except as required under applicable law.
Corporate Contact: Rebecca Kusko,
Ph.D. Immuneering
Corporation rkusko@immuneering.com 617-500-8080 Investor
Contact: Susan A. Noonan S.A. Noonan
Communications susan@sanoonan.com 917-513-5303
IMMUNEERING CORPORATION
CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
38,380 |
|
|
$ |
482,130 |
|
|
$ |
316,497 |
|
|
$ |
1,890,370 |
|
Cost of
revenue |
|
|
19,343 |
|
|
|
219,088 |
|
|
|
158,122 |
|
|
|
946,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit |
|
|
19,037 |
|
|
|
263,042 |
|
|
|
158,375 |
|
|
|
943,518 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
9,363,838 |
|
|
|
6,207,486 |
|
|
|
26,395,355 |
|
|
|
18,590,471 |
|
General and administrative |
|
|
3,836,032 |
|
|
|
2,598,940 |
|
|
|
11,500,144 |
|
|
|
5,123,361 |
|
Amortization of intangible asset |
|
|
7,317 |
|
|
|
— |
|
|
|
22,737 |
|
|
|
— |
|
Total operating expenses |
|
|
13,207,187 |
|
|
|
8,806,426 |
|
|
|
37,918,236 |
|
|
|
23,713,832 |
|
Loss from operations |
|
|
(13,188,150 |
) |
|
|
(8,543,384 |
) |
|
|
(37,759,861 |
) |
|
|
(22,770,314 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
222,985 |
|
|
|
17,400 |
|
|
|
498,288 |
|
|
|
27,014 |
|
Other income (expense) |
|
|
120,835 |
|
|
|
(8,089 |
) |
|
|
(6,434 |
) |
|
|
(8,089 |
) |
Net loss |
|
$ |
(12,844,330 |
) |
|
$ |
(8,534,073 |
) |
|
$ |
(37,268,007 |
) |
|
$ |
(22,751,389 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.41 |
) |
|
$ |
(2.41 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
26,394,490 |
|
|
|
18,286,352 |
|
|
|
26,380,101 |
|
|
|
9,445,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains/(losses) from marketable securities |
|
|
39,088 |
|
|
|
(4,751 |
) |
|
|
(93,464 |
) |
|
|
(4,751 |
) |
Comprehensive
Loss |
|
$ |
(12,805,242 |
) |
|
$ |
(8,538,824 |
) |
|
$ |
(37,361,471 |
) |
|
$ |
(22,756,140 |
) |
IMMUNEERING CORPORATION
CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
|
|
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Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
76,417,850 |
|
|
$ |
74,888,145 |
|
Marketable securities, current |
|
|
40,779,440 |
|
|
|
74,311,203 |
|
Accounts receivable |
|
|
70,180 |
|
|
|
246,040 |
|
Prepaids and other current assets |
|
|
2,757,220 |
|
|
|
2,888,608 |
|
Total current assets |
|
|
120,024,690 |
|
|
|
152,333,996 |
|
|
|
|
|
|
|
|
Marketable securities,
non-current |
|
|
— |
|
|
|
996,560 |
|
Property and equipment, net |
|
|
1,310,067 |
|
|
|
807,223 |
|
Goodwill |
|
|
6,690,431 |
|
|
|
6,701,726 |
|
Intangible asset |
|
|
416,263 |
|
|
|
439,000 |
|
Right-of-use assets, net |
|
|
4,512,883 |
|
|
|
5,324,198 |
|
Other assets |
|
|
737,293 |
|
|
|
102,129 |
|
Total assets |
|
$ |
133,691,627 |
|
|
$ |
166,704,832 |
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,338,380 |
|
|
$ |
1,394,340 |
|
Accrued expenses |
|
|
4,564,136 |
|
|
|
3,965,447 |
|
Other liabilities, current |
|
|
44,562 |
|
|
|
— |
|
Lease liabilities, current |
|
|
308,694 |
|
|
|
274,039 |
|
Total current liabilities |
|
|
7,255,772 |
|
|
|
5,633,826 |
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
Lease liabilities, non-current |
|
|
4,542,653 |
|
|
|
5,090,897 |
|
Total liabilities |
|
|
11,798,425 |
|
|
|
10,724,723 |
|
Commitments and contingencies
(Note 12) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized at September 30, 2022 and
December 31, 2021; 0 shares issued or outstanding at September 30,
2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Class A common stock, $0.001 par
value, 200,000,000 shares authorized at September 30, 2022 and
December 31, 2021; 26,404,732 and 26,320,199 shares issued and
outstanding at September 30, 2022 and
December 31, 2021, respectively |
|
|
26,405 |
|
|
|
26,320 |
|
Class B common stock, $0.001 par
value, 20,000,000 shares authorized at September 30, 2022 and
December 31, 2021; 0 shares issued and outstanding at
September 30, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
218,550,665 |
|
|
|
215,276,186 |
|
Accumulated other comprehensive
loss |
|
|
(142,473 |
) |
|
|
(49,009 |
) |
Accumulated deficit |
|
|
(96,541,395 |
) |
|
|
(59,273,388 |
) |
Total stockholders' equity |
|
|
121,893,202 |
|
|
|
155,980,109 |
|
Total liabilities and stockholders' equity |
|
$ |
133,691,627 |
|
|
$ |
166,704,832 |
|
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